DALLAS – Salpingectomy – which can reduce the risk for later ovarian cancer – was completed successfully in about two-thirds of women who desired permanent contraception at cesarean delivery and were randomized to receive this procedure rather than simple tubal ligation.
In a study of 80 patients, operative times were longer by 15 minutes for those who received salpingectomy, and neither group had adverse outcomes or serious complications, according to Akila Subramaniam, MD, who presented the findings of the single-site Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) trial at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The strategy to perform salpingectomy during cesarean delivery may be one way to reduce the incidence of ovarian cancer, “the most lethal gynecologic malignancy in the United States,” said Dr. Subramaniam, a maternal-fetal medicine specialist at the University of Alabama at Birmingham. “Primary prevention is the focus to reduce the ovarian cancer burden.”
However, Dr. Subramaniam said, there had been limited prospective data on salpingectomy performed at the time of cesarean delivery. One theoretical concern is an increased risk of bleeding; another is the additional operative time required for a potentially difficult dissection of the entire fallopian tube.
Dr. Subramaniam and her colleagues constructed a clinical trial that asked patients who were receiving cesarean delivery and who desired surgical sterilization to agree to randomization to complete salpingectomy or standard tubal ligation. Patient allocation was determined by computer-generated numbers, placed in a sealed envelope, and revealed to the surgeon only at the time of the opening incision for the cesarean procedure. Patients were unaware of the allocation until hospital discharge.
The single-center trial enrolled women undergoing a planned cesarean delivery at 35 or more weeks’ gestation, including those who had previous cesareans and women with multiple gestations or fetal malpresentations. Women who went on to cesarean after a trial of labor after prior cesarean were also eligible.
Patients younger than 25 years and patients with known fetal anomalies or fetal demise were excluded, as were women with previous tubal surgery and those who were anticoagulated or had immunodeficiency. The study did not enroll women who were known to carry the BRCA mutation.
Patients who were randomized to the intervention arm received a complete salpingectomy involving excision from the fimbriae to within 1 cm of the cornua, when technically feasible. The control arm participants received a standard bilateral tubal ligation using either the modified Pomeroy technique or the Parkland technique.
All study participants received routine pre- and postoperative care and instructions, and had study follow-up visits at 1 and 6 weeks post partum.
The study had two primary endpoints: rate of bilateral completion of the randomized procedure, and mean total operative time measured from skin incision to closure. Secondary outcomes included assessments of blood loss and surgical complications, followed through the 6-week postpartum visit.
The study just met the predetermined statistical power needed to detect a 10-minute difference in operative time, enrolling 80 patients and randomizing 40 to each arm.
Of the 40 patients randomized to salpingectomy, 27 (67.5%) received the intended complete salpingectomy. Three had a unilateral salpingectomy, with a tubal ligation contralaterally. Eight patients received bilateral tubal ligations, and in two patients, the surgeon was unable to perform any sterilization procedure at all.
In the tubal ligation arm, 38 patients (95%) received bilateral tubal ligation, 1 patient received a unilateral tubal ligation and a unilateral salpingectomy, and 1 patient received no procedure. The difference in success of completing the intended procedures between the two study arms was statistically significant (P = .002); in both groups, adhesions and scarring were the primary impediments to successful completion of the intended procedure, Dr. Subramaniam said.
Operative times were longer by about 15 minutes in the salpingectomy arm, with the difference accounted for by the longer duration of the sterilization procedure. No significant differences were seen in estimated blood loss or decrease in hematocrit between the two groups, and pain scores were similar.
The study, which successfully recruited 80 women from 221 approached, “may be underpowered for safety outcomes,” said Dr. Subramaniam. She also pointed out that there was no assessment of ovarian reserve, and that it’s not possible to assess the true risk reduction of salpingectomy in this study design.
Still, “It’s reasonable to consider this surgical sterilization method during cesarean as an ovarian cancer risk-reducing strategy.” One impediment to study recruitment, she said, was that after receiving education about salpingectomy, many patients desired salpingectomy and were not willing to risk randomization to simple tubal ligation.
Dr. Subramaniam reported receiving research funding for the study from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.