SAGES Annual Meeting 2011

It's time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care.

In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor's work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it's extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it's time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn't be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them.

Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn't happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business.

The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors.

Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I'm sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It's time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care.

In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor's work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it's extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it's time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn't be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them.

Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn't happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business.

The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors.

Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I'm sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It's time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care.

In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor's work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it's extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it's time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn't be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them.

Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn't happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business.

The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors.

Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I'm sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care. In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it’s extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it’s time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn’t be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business. The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors. Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I’m sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. He is a former president of the Society of American Gastrointestinal and Endoscopic Surgeons. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care. In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it’s extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it’s time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn’t be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business. The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors. Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I’m sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. He is a former president of the Society of American Gastrointestinal and Endoscopic Surgeons. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care. In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it’s extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it’s time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn’t be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business. The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors. Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I’m sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. He is a former president of the Society of American Gastrointestinal and Endoscopic Surgeons. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care. In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it’s extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it’s time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn’t be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business. The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors. Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I’m sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. He is a former president of the Society of American Gastrointestinal and Endoscopic Surgeons. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care. In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it’s extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it’s time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn’t be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business. The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors. Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I’m sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. He is a former president of the Society of American Gastrointestinal and Endoscopic Surgeons. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

It’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry. The insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care. In reality, we need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

The Institute of Medicine defines a professional conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal" (N. Engl. J. Med. 2009;360:2160-3).

Many of us find ourselves conflicted professionally when we participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. In such situations, we are asked to use our judgment and place the interest of what we are trying to do above our own personal interests. We are never asked to disclose these other kinds of conflicts, and it’s extremely rare that we are asked to excuse ourselves from the process.

In fact, one of the greatest conflicts of interest we have as physicians is the way in which we are reimbursed – whether by capitation or fee for service. What is in our personal best interest may not line up with what is best for our patients, but this is not something we disclose. So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively? In the spirit of evidence-based medicine, it’s time to bring balance to this heated debate.

I have been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years, and I am certain that this society wouldn’t be what it is today if the conflict-of-interest rules currently being forced on us had existed in the 1990s or the early part of the past decade.

When I joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. Our leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass. To the best of my knowledge, no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that our patients will benefit.

Similarly, most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques. If future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.

With respect to research, the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous. Certainly companies want to be successful, but doing so at the expense of patient health and safety would simply be bad business. The financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it. Additionally, drug and device companies anticipate the rigors of the Food and Drug Administration review that is required before their products are brought to market. If fraud is discovered or a patient harmed, the consequences can put the company out of business.

Investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly. The research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors. Before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities. I’m sure that conflicts were ubiquitous, but the bottom line is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.

The onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.

Financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.

Dr. David William Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston. He is a former president of the Society of American Gastrointestinal and Endoscopic Surgeons. The comments presented here are drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting. He disclosed financial relationships with Olympus and Transenterix-SAB.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.