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Fibroids: Growing management options for a prevalent problem

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OBG Manag. 33(12). | doi 10.12788/obgm.0169

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Clinical Edge Journal Scan Commentary: Uterine Fibroids December 2021

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Dr. Christianson scans the journals, so you don’t have to!

Mindy S. Christianson, M.D.
Relugolix, an oral GnRH antagonist, effectively reduces menstrual blood loss due to uterine fibroids, according to a recently published randomized controlled trial published in BMC Womens Health. The phase 2, multicenter, double-blind, parallel-group study was conducted at 36 sites in Japan in women with uterine fibroids and heavy menstrual bleeding, defined by a pictorial blood loss assessment chart (PBAC) score of ≥ 120 in one menstrual cycle. Overall, 216 premenopausal women were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo. The primary endpoint was the proportion of patients with a total PBAC score of < 10 from week 6 to 12. Between weeks 6 to 12, the proportion of patients with a PBAC score of less than 10 was higher in the relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-associated adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) versus placebo (70.2%).

A recent study by Lee et al in the Journal of Obstetrics and Gynaecology Research evaluated the feasibility of robotic single-port myomectomy (RSPM) using the da Vinci SP surgical system. In this prospective observational study, 61 women with symptomatic fibroids underwent RSPM. In women with less than 7 resected uterine fibroids (maximal diameter < 10 cm) as well as those with at least 7 resected fibroids (maximal diameter of resected fibroids ≥10 cm), there was no conversion to single-port laparoscopic myomectomy, multiport laparoscopic myomectomy, or laparotomy. Reported complications were minor and included fever, transient ileus and blood transfusion in 15 patients. The authors proposed that robotic single-port myomectomy could solve many of the ergonomic problems associated with single-port laparoscopic myomectomy.

When performing myomectomy during C-section, is there a method that is advantageous? This question was evaluated by Karaca SY et al in European Journal of Obstetrics and Gynecology and Reproductive Biology who compared transendometrial myomectomy with conventional myomectomy. Overall, 41 patients underwent transendometrial myomectomy, and 52 patients underwent conventional myomectomy, with all patients having one single anterior intramural fibroid removed. The mean duration of surgery (50.5 minutes vs 63.6 minutes; P = .001) was lower in the transendometrial group versus the conventional myomectomy group. Additionally, patients who underwent transendometrial myomectomy (0.58 ± 0.61) had significantly lower adhesion scores in their subsequent pregnancy compared to patients who underwent conventional myomectomy (1,76 ± 1,1) (P = 0.001). Length of hospital stay, procedure-related hemoglobin difference, blood transfusion requirement, and postoperative fever were similar in both groups.

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Mindy S. Christianson, MD Medical Director, Johns Hopkins Fertility Center
Associate Professor, Division of Reproductive Endocrinology and Infertility
Johns Hopkins University School of Medicine

Dr. Christianson has no disclosures. 

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Mindy S. Christianson, MD Medical Director, Johns Hopkins Fertility Center
Associate Professor, Division of Reproductive Endocrinology and Infertility
Johns Hopkins University School of Medicine

Dr. Christianson has no disclosures. 

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Mindy S. Christianson, MD Medical Director, Johns Hopkins Fertility Center
Associate Professor, Division of Reproductive Endocrinology and Infertility
Johns Hopkins University School of Medicine

Dr. Christianson has no disclosures. 

Dr. Christianson scans the journals, so you don’t have to!
Dr. Christianson scans the journals, so you don’t have to!

Mindy S. Christianson, M.D.
Relugolix, an oral GnRH antagonist, effectively reduces menstrual blood loss due to uterine fibroids, according to a recently published randomized controlled trial published in BMC Womens Health. The phase 2, multicenter, double-blind, parallel-group study was conducted at 36 sites in Japan in women with uterine fibroids and heavy menstrual bleeding, defined by a pictorial blood loss assessment chart (PBAC) score of ≥ 120 in one menstrual cycle. Overall, 216 premenopausal women were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo. The primary endpoint was the proportion of patients with a total PBAC score of < 10 from week 6 to 12. Between weeks 6 to 12, the proportion of patients with a PBAC score of less than 10 was higher in the relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-associated adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) versus placebo (70.2%).

A recent study by Lee et al in the Journal of Obstetrics and Gynaecology Research evaluated the feasibility of robotic single-port myomectomy (RSPM) using the da Vinci SP surgical system. In this prospective observational study, 61 women with symptomatic fibroids underwent RSPM. In women with less than 7 resected uterine fibroids (maximal diameter < 10 cm) as well as those with at least 7 resected fibroids (maximal diameter of resected fibroids ≥10 cm), there was no conversion to single-port laparoscopic myomectomy, multiport laparoscopic myomectomy, or laparotomy. Reported complications were minor and included fever, transient ileus and blood transfusion in 15 patients. The authors proposed that robotic single-port myomectomy could solve many of the ergonomic problems associated with single-port laparoscopic myomectomy.

When performing myomectomy during C-section, is there a method that is advantageous? This question was evaluated by Karaca SY et al in European Journal of Obstetrics and Gynecology and Reproductive Biology who compared transendometrial myomectomy with conventional myomectomy. Overall, 41 patients underwent transendometrial myomectomy, and 52 patients underwent conventional myomectomy, with all patients having one single anterior intramural fibroid removed. The mean duration of surgery (50.5 minutes vs 63.6 minutes; P = .001) was lower in the transendometrial group versus the conventional myomectomy group. Additionally, patients who underwent transendometrial myomectomy (0.58 ± 0.61) had significantly lower adhesion scores in their subsequent pregnancy compared to patients who underwent conventional myomectomy (1,76 ± 1,1) (P = 0.001). Length of hospital stay, procedure-related hemoglobin difference, blood transfusion requirement, and postoperative fever were similar in both groups.

Mindy S. Christianson, M.D.
Relugolix, an oral GnRH antagonist, effectively reduces menstrual blood loss due to uterine fibroids, according to a recently published randomized controlled trial published in BMC Womens Health. The phase 2, multicenter, double-blind, parallel-group study was conducted at 36 sites in Japan in women with uterine fibroids and heavy menstrual bleeding, defined by a pictorial blood loss assessment chart (PBAC) score of ≥ 120 in one menstrual cycle. Overall, 216 premenopausal women were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo. The primary endpoint was the proportion of patients with a total PBAC score of < 10 from week 6 to 12. Between weeks 6 to 12, the proportion of patients with a PBAC score of less than 10 was higher in the relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-associated adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) versus placebo (70.2%).

A recent study by Lee et al in the Journal of Obstetrics and Gynaecology Research evaluated the feasibility of robotic single-port myomectomy (RSPM) using the da Vinci SP surgical system. In this prospective observational study, 61 women with symptomatic fibroids underwent RSPM. In women with less than 7 resected uterine fibroids (maximal diameter < 10 cm) as well as those with at least 7 resected fibroids (maximal diameter of resected fibroids ≥10 cm), there was no conversion to single-port laparoscopic myomectomy, multiport laparoscopic myomectomy, or laparotomy. Reported complications were minor and included fever, transient ileus and blood transfusion in 15 patients. The authors proposed that robotic single-port myomectomy could solve many of the ergonomic problems associated with single-port laparoscopic myomectomy.

When performing myomectomy during C-section, is there a method that is advantageous? This question was evaluated by Karaca SY et al in European Journal of Obstetrics and Gynecology and Reproductive Biology who compared transendometrial myomectomy with conventional myomectomy. Overall, 41 patients underwent transendometrial myomectomy, and 52 patients underwent conventional myomectomy, with all patients having one single anterior intramural fibroid removed. The mean duration of surgery (50.5 minutes vs 63.6 minutes; P = .001) was lower in the transendometrial group versus the conventional myomectomy group. Additionally, patients who underwent transendometrial myomectomy (0.58 ± 0.61) had significantly lower adhesion scores in their subsequent pregnancy compared to patients who underwent conventional myomectomy (1,76 ± 1,1) (P = 0.001). Length of hospital stay, procedure-related hemoglobin difference, blood transfusion requirement, and postoperative fever were similar in both groups.

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Bipolar loop resectoscopic slicing aids in safer and faster enucleation of submucous uterine fibroids

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Key clinical point: Enucleation of submucous uterine fibroids (UF) under hysteroscopy can be achieved by a modified resectoscopic slicing using a bipolar loop, which appeared safe and faster compared with classical resectoscopic myomectomy.

Major finding: Mean operation time (22.9 minutes vs 38.9 minutes; P < .001) and volume of mean distending media (1,495.6 mL vs 2,393.1 mL; P < .001) were significantly shorter in the modified vs classical resectoscopic slicing group. The classical group witnessed 3 cases of fluid overload and 1 case of uterine perforation, whereas none of these postoperative complications occurred in the modified technique group.

Study details: Findings are from a retrospective study including 55 women with submucous UFs, of which 19 women underwent modified resectoscopic slicing and 36 women underwent the classical resectoscopic myomectomy.

Disclosures: This study was funded by Shanghai Municipal Health Commission, China. The authors declared no conflict of interests.

Source: Zhang W et al. Front Surg. 2021 Nov 10. doi: 10.3389/fsurg.2021.746936.

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Key clinical point: Enucleation of submucous uterine fibroids (UF) under hysteroscopy can be achieved by a modified resectoscopic slicing using a bipolar loop, which appeared safe and faster compared with classical resectoscopic myomectomy.

Major finding: Mean operation time (22.9 minutes vs 38.9 minutes; P < .001) and volume of mean distending media (1,495.6 mL vs 2,393.1 mL; P < .001) were significantly shorter in the modified vs classical resectoscopic slicing group. The classical group witnessed 3 cases of fluid overload and 1 case of uterine perforation, whereas none of these postoperative complications occurred in the modified technique group.

Study details: Findings are from a retrospective study including 55 women with submucous UFs, of which 19 women underwent modified resectoscopic slicing and 36 women underwent the classical resectoscopic myomectomy.

Disclosures: This study was funded by Shanghai Municipal Health Commission, China. The authors declared no conflict of interests.

Source: Zhang W et al. Front Surg. 2021 Nov 10. doi: 10.3389/fsurg.2021.746936.

Key clinical point: Enucleation of submucous uterine fibroids (UF) under hysteroscopy can be achieved by a modified resectoscopic slicing using a bipolar loop, which appeared safe and faster compared with classical resectoscopic myomectomy.

Major finding: Mean operation time (22.9 minutes vs 38.9 minutes; P < .001) and volume of mean distending media (1,495.6 mL vs 2,393.1 mL; P < .001) were significantly shorter in the modified vs classical resectoscopic slicing group. The classical group witnessed 3 cases of fluid overload and 1 case of uterine perforation, whereas none of these postoperative complications occurred in the modified technique group.

Study details: Findings are from a retrospective study including 55 women with submucous UFs, of which 19 women underwent modified resectoscopic slicing and 36 women underwent the classical resectoscopic myomectomy.

Disclosures: This study was funded by Shanghai Municipal Health Commission, China. The authors declared no conflict of interests.

Source: Zhang W et al. Front Surg. 2021 Nov 10. doi: 10.3389/fsurg.2021.746936.

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Comparative analysis of thermal ablative methods vs myomectomy for uterine fibroids

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Key clinical point: Rates of reintervention were similar, and the risk for major adverse events was lower with thermal ablative methods vs myomectomy for treating uterine fibroids (UF), suggesting that thermal ablative methods were not inferior to myomectomy for treating UFs.

Major finding: The reintervention rate was not significantly different between thermal ablative treatment and myomectomy in randomized controlled trials (RCTs; P = .094) and observational studies (P = .16). The risk for major adverse events was significantly lower with thermal ablative methods (risk ratio, 0.111; 95% CI, 0.070-0.175). The pregnancy rate was not significantly different between the groups (P = .796).

Study details: Findings are from a meta-analysis of 10 observational studies and 3 RCTs including 4,205 patients who underwent thermal ablative methods or myomectomy for the treatment of UFs.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Liang D et al. Int J Hyperthermia. 2021 Nov 1. doi: 10.1080/02656736.2021.1996644.

 

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Key clinical point: Rates of reintervention were similar, and the risk for major adverse events was lower with thermal ablative methods vs myomectomy for treating uterine fibroids (UF), suggesting that thermal ablative methods were not inferior to myomectomy for treating UFs.

Major finding: The reintervention rate was not significantly different between thermal ablative treatment and myomectomy in randomized controlled trials (RCTs; P = .094) and observational studies (P = .16). The risk for major adverse events was significantly lower with thermal ablative methods (risk ratio, 0.111; 95% CI, 0.070-0.175). The pregnancy rate was not significantly different between the groups (P = .796).

Study details: Findings are from a meta-analysis of 10 observational studies and 3 RCTs including 4,205 patients who underwent thermal ablative methods or myomectomy for the treatment of UFs.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Liang D et al. Int J Hyperthermia. 2021 Nov 1. doi: 10.1080/02656736.2021.1996644.

 

Key clinical point: Rates of reintervention were similar, and the risk for major adverse events was lower with thermal ablative methods vs myomectomy for treating uterine fibroids (UF), suggesting that thermal ablative methods were not inferior to myomectomy for treating UFs.

Major finding: The reintervention rate was not significantly different between thermal ablative treatment and myomectomy in randomized controlled trials (RCTs; P = .094) and observational studies (P = .16). The risk for major adverse events was significantly lower with thermal ablative methods (risk ratio, 0.111; 95% CI, 0.070-0.175). The pregnancy rate was not significantly different between the groups (P = .796).

Study details: Findings are from a meta-analysis of 10 observational studies and 3 RCTs including 4,205 patients who underwent thermal ablative methods or myomectomy for the treatment of UFs.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Liang D et al. Int J Hyperthermia. 2021 Nov 1. doi: 10.1080/02656736.2021.1996644.

 

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Simultaneous hysteromyoma enucleation and C-section safely remove anterior UFs without additional incision

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Key clinical point: Hysteromyoma enucleation performed simultaneously during the cesarean section (C-section) is safe without any surgical complications in pregnant women with anterior uterine fibroids (UF).

Major finding: The operation time (median, 83.3 minutes vs 72.5 minutes; P = .04) and postoperative hospital stays (median, 3.6 days vs 3.2 days; P = .01) were slightly longer in the group of patients whose UFs were removed by C-section incision vs those who were operated traditionally by an incision through the serous layer. Pre- and postoperative hemoglobin level, intraoperative bleeding, frequency of blood transfusion, postpartum hemorrhage, and fever were similar between both groups, with no postoperative complications observed in either group.

Study details: Findings are from a retrospective analysis of 90 pregnant women with anterior UFs who underwent hysteromyoma enucleation simultaneously during C-section.

Disclosures: This study was funded by the Fujian Provincial Maternity and Children’s Hospital Science Foundation. The authors declared no conflict of interests.

Source: Dai Y et al. BMC Pregnancy Childbirth. 2021 Nov 3. doi: 10.1186/s12884-021-04226-1.

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Key clinical point: Hysteromyoma enucleation performed simultaneously during the cesarean section (C-section) is safe without any surgical complications in pregnant women with anterior uterine fibroids (UF).

Major finding: The operation time (median, 83.3 minutes vs 72.5 minutes; P = .04) and postoperative hospital stays (median, 3.6 days vs 3.2 days; P = .01) were slightly longer in the group of patients whose UFs were removed by C-section incision vs those who were operated traditionally by an incision through the serous layer. Pre- and postoperative hemoglobin level, intraoperative bleeding, frequency of blood transfusion, postpartum hemorrhage, and fever were similar between both groups, with no postoperative complications observed in either group.

Study details: Findings are from a retrospective analysis of 90 pregnant women with anterior UFs who underwent hysteromyoma enucleation simultaneously during C-section.

Disclosures: This study was funded by the Fujian Provincial Maternity and Children’s Hospital Science Foundation. The authors declared no conflict of interests.

Source: Dai Y et al. BMC Pregnancy Childbirth. 2021 Nov 3. doi: 10.1186/s12884-021-04226-1.

Key clinical point: Hysteromyoma enucleation performed simultaneously during the cesarean section (C-section) is safe without any surgical complications in pregnant women with anterior uterine fibroids (UF).

Major finding: The operation time (median, 83.3 minutes vs 72.5 minutes; P = .04) and postoperative hospital stays (median, 3.6 days vs 3.2 days; P = .01) were slightly longer in the group of patients whose UFs were removed by C-section incision vs those who were operated traditionally by an incision through the serous layer. Pre- and postoperative hemoglobin level, intraoperative bleeding, frequency of blood transfusion, postpartum hemorrhage, and fever were similar between both groups, with no postoperative complications observed in either group.

Study details: Findings are from a retrospective analysis of 90 pregnant women with anterior UFs who underwent hysteromyoma enucleation simultaneously during C-section.

Disclosures: This study was funded by the Fujian Provincial Maternity and Children’s Hospital Science Foundation. The authors declared no conflict of interests.

Source: Dai Y et al. BMC Pregnancy Childbirth. 2021 Nov 3. doi: 10.1186/s12884-021-04226-1.

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Robotic single-port myomectomy using da Vinci SP surgical system feasible for treating symptomatic fibroids

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Key clinical point: Robotic single-port myomectomy (RSPM) using the da Vinci SP surgical system for treating symptomatic fibroids was a feasible surgical procedure and could solve many of the ergonomic problems associated with single-port laparoscopic myomectomy (SPLM).

Major finding: Conversion to SPLM, multiport laparoscopic myomectomy, or laparotomy was not required in women with less than 7 resected fibroids (maximal diameter <10 cm) and those with at least 7 resected fibroids (maximal diameter of resected fibroids ≥10 cm). Minor postoperative complications like fever, transient ileus, and transfusion were observed in 15 women, which could be resolved by conservative treatment.

Study details: Findings are from a prospective observational study including 69 women with symptomatic fibroids who underwent myomectomy, of which 61 women underwent RSPM.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Lee JH et al. J Obstet Gynaecol Res. 2021 Oct 23. doi: 10.1111/jog.15076.

 

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Key clinical point: Robotic single-port myomectomy (RSPM) using the da Vinci SP surgical system for treating symptomatic fibroids was a feasible surgical procedure and could solve many of the ergonomic problems associated with single-port laparoscopic myomectomy (SPLM).

Major finding: Conversion to SPLM, multiport laparoscopic myomectomy, or laparotomy was not required in women with less than 7 resected fibroids (maximal diameter <10 cm) and those with at least 7 resected fibroids (maximal diameter of resected fibroids ≥10 cm). Minor postoperative complications like fever, transient ileus, and transfusion were observed in 15 women, which could be resolved by conservative treatment.

Study details: Findings are from a prospective observational study including 69 women with symptomatic fibroids who underwent myomectomy, of which 61 women underwent RSPM.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Lee JH et al. J Obstet Gynaecol Res. 2021 Oct 23. doi: 10.1111/jog.15076.

 

Key clinical point: Robotic single-port myomectomy (RSPM) using the da Vinci SP surgical system for treating symptomatic fibroids was a feasible surgical procedure and could solve many of the ergonomic problems associated with single-port laparoscopic myomectomy (SPLM).

Major finding: Conversion to SPLM, multiport laparoscopic myomectomy, or laparotomy was not required in women with less than 7 resected fibroids (maximal diameter <10 cm) and those with at least 7 resected fibroids (maximal diameter of resected fibroids ≥10 cm). Minor postoperative complications like fever, transient ileus, and transfusion were observed in 15 women, which could be resolved by conservative treatment.

Study details: Findings are from a prospective observational study including 69 women with symptomatic fibroids who underwent myomectomy, of which 61 women underwent RSPM.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Lee JH et al. J Obstet Gynaecol Res. 2021 Oct 23. doi: 10.1111/jog.15076.

 

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Transendometrial myomectomy bests conventional surgery for fibroids in C-section

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Key clinical point: Transendometrial myomectomy (TEM) could be more advantageous than conventional myomectomy (CM) for uterine fibroids (UF) in cesarean section (C-section) for its shorter operation time and lesser adhesion scores.

Major finding: The mean duration of surgery (50.5 minutes vs 63.6 minutes; P = .001) and adhesion scores were significantly lower (0.58 vs 1.76; P = .001) in the TEM than CM group; however, length of hospital stay, procedure-related hemoglobin difference, blood transfusion requirement, and postoperative fever were similar in both groups.

Study details: Findings are from a retrospective study including 93 patients with intramural UFs and underwent myomectomy during C-section. CM and TEM were performed in 52 and 41 patients, respectively.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Karaca SY et al. Eur J Obstet Gynecol. 2021 Oct 21. doi: 10.1016/j.ejogrb.2021.10.019.

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Key clinical point: Transendometrial myomectomy (TEM) could be more advantageous than conventional myomectomy (CM) for uterine fibroids (UF) in cesarean section (C-section) for its shorter operation time and lesser adhesion scores.

Major finding: The mean duration of surgery (50.5 minutes vs 63.6 minutes; P = .001) and adhesion scores were significantly lower (0.58 vs 1.76; P = .001) in the TEM than CM group; however, length of hospital stay, procedure-related hemoglobin difference, blood transfusion requirement, and postoperative fever were similar in both groups.

Study details: Findings are from a retrospective study including 93 patients with intramural UFs and underwent myomectomy during C-section. CM and TEM were performed in 52 and 41 patients, respectively.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Karaca SY et al. Eur J Obstet Gynecol. 2021 Oct 21. doi: 10.1016/j.ejogrb.2021.10.019.

Key clinical point: Transendometrial myomectomy (TEM) could be more advantageous than conventional myomectomy (CM) for uterine fibroids (UF) in cesarean section (C-section) for its shorter operation time and lesser adhesion scores.

Major finding: The mean duration of surgery (50.5 minutes vs 63.6 minutes; P = .001) and adhesion scores were significantly lower (0.58 vs 1.76; P = .001) in the TEM than CM group; however, length of hospital stay, procedure-related hemoglobin difference, blood transfusion requirement, and postoperative fever were similar in both groups.

Study details: Findings are from a retrospective study including 93 patients with intramural UFs and underwent myomectomy during C-section. CM and TEM were performed in 52 and 41 patients, respectively.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Karaca SY et al. Eur J Obstet Gynecol. 2021 Oct 21. doi: 10.1016/j.ejogrb.2021.10.019.

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Relugolix, a promising therapeutic option for uterine leiomyomas-associated menstrual blood loss

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Key clinical point: Relugolix monotherapy effectively reduced menstrual blood loss associated with uterine leiomyomas (UL) along with an acceptable tolerability profile.

Major finding: Between weeks 6 to 12, the proportion of patients with pictorial blood loss assessment chart score of less than 10 was higher in relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-emergent adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) vs placebo (70.2%).

Study details: Findings are from a phase 2 trial, including 216 premenopausal women with UL who were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo.

Disclosures: This study was funded by Takeda Pharmaceutical Company. The lead author reported receiving consultancy fees from Takeda Pharmaceutical Company, and other authors reported being current/former employees of the company.

Source: Hoshiai H et al. BMC Womens Health. 2021 Oct 28. doi: 10.1186/s12905-021-01475-2.

 

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Key clinical point: Relugolix monotherapy effectively reduced menstrual blood loss associated with uterine leiomyomas (UL) along with an acceptable tolerability profile.

Major finding: Between weeks 6 to 12, the proportion of patients with pictorial blood loss assessment chart score of less than 10 was higher in relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-emergent adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) vs placebo (70.2%).

Study details: Findings are from a phase 2 trial, including 216 premenopausal women with UL who were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo.

Disclosures: This study was funded by Takeda Pharmaceutical Company. The lead author reported receiving consultancy fees from Takeda Pharmaceutical Company, and other authors reported being current/former employees of the company.

Source: Hoshiai H et al. BMC Womens Health. 2021 Oct 28. doi: 10.1186/s12905-021-01475-2.

 

Key clinical point: Relugolix monotherapy effectively reduced menstrual blood loss associated with uterine leiomyomas (UL) along with an acceptable tolerability profile.

Major finding: Between weeks 6 to 12, the proportion of patients with pictorial blood loss assessment chart score of less than 10 was higher in relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-emergent adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) vs placebo (70.2%).

Study details: Findings are from a phase 2 trial, including 216 premenopausal women with UL who were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo.

Disclosures: This study was funded by Takeda Pharmaceutical Company. The lead author reported receiving consultancy fees from Takeda Pharmaceutical Company, and other authors reported being current/former employees of the company.

Source: Hoshiai H et al. BMC Womens Health. 2021 Oct 28. doi: 10.1186/s12905-021-01475-2.

 

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Clinical Edge Journal Scan: Uterine Fibroids December 2021
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Clinical Edge Journal Scan Commentary: Uterine Fibroids November 2021

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Fri, 05/13/2022 - 16:34
Dr. Christianson scans the journals, so you don’t have to!

Mindy S. Christianson, MD
Which technique is superior for laparoscopic myomectomy (LM) -  single-port laparoscopy or traditional three-port laparoscopy? Jiang et al examined this question in a retrospective review in Frontiers in Oncology. Sixty patients underwent single-port LM and 60 were treated with traditional 3-port LM. Single-port LM outperformed 3-port LM in the following areas: faster specimen removal time, quicker postoperative ambulation time, shorter hospital stay (all P < .05). Patients reported greater abdominal scar satisfaction scores with single-port versus 3-port LM (4.17 vs 3.47; P = .00). Intraoperative blood loss was similar in both groups (P > .05). In terms of clinical care, patients can be counseled that single-port LM for treating certain uterine fibroids demonstrated faster recovery and higher patient satisfaction in this study, although larger randomized trials are needed.

Mahalingam et al in the Journal of Maternal-Fetal & Neonatal Medicine reported the risk of preterm birth among women with uterine fibroids who underwent myomectomy versus those who did not prior to pregnancy. In this retrospective cohort study, the team evaluated 290 women with a viable intrauterine pregnancy and history of uterine fibroids and compared two groups: 70 with history of a prior myomectomy and 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation. The team found that women who underwent prior myomectomy versus those who did not were more likely to deliver preterm < 37 weeks gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks gestation; P = .02). Patients with history of myomectomy had a higher C-section rate (88% vs 53%, P < 0.001). However, when the authors controlled for late preterm pre-labor C-sections recommended by physicians in the myomectomy cohort (n=5), the difference in preterm birth was not significant between the groups.

Lee et al reported that MRI can potentially predict the benefit of GnRH-agonist treatment prior to for large fibroids. In this retrospective analysis published in Acta Radiologica, 30 patients with large uterine fibroids received GnRH agonist prior to uterine artery embolization (UAE) with MRI evaluation before and after treatment. Indications for GnRH-agonist treatment (monthly 3.75 mg leuprolide acetate injections) included intramural or subserosal fibroids > 10 cm in diameter or pedunculated submucosal fibroids > 8 cm, as well as contrast enhancement observed on T1-weighted (T1W) images. Mean maximum fibroid diameter was 11.1 + 1.9 cm and mean number of GnRH-agonist injections received was 2.8. Signal intensity (SI) of the predominant fibroid on T2-weighted (T2W) images was referenced to the SI of the rectus abdominus muscle (F/R). For predicting a volume reduction rate of the large fibroid of >50%, the optimal cut-off value of F/R was 2.58 (sensitivity 80%, specificity 80%). Likewise, large fibroids with a volume rate reduction of <30% had an optimal cut-off volume of 1.69 (sensitivity 100%, specificity 70%). From a clinical perspective, both surgeons and radiologists could use SI of the predominant fibroid on T2W to predict response to GnRH agonist pretreatment.

Author and Disclosure Information

Mindy S. Christianson, MD Medical Director, Johns Hopkins Fertility Center
Associate Professor, Division of Reproductive Endocrinology and Infertility
Johns Hopkins University School of Medicine

Dr. Christianson has no disclosures. 

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Mindy S. Christianson, MD Medical Director, Johns Hopkins Fertility Center
Associate Professor, Division of Reproductive Endocrinology and Infertility
Johns Hopkins University School of Medicine

Dr. Christianson has no disclosures. 

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Mindy S. Christianson, MD Medical Director, Johns Hopkins Fertility Center
Associate Professor, Division of Reproductive Endocrinology and Infertility
Johns Hopkins University School of Medicine

Dr. Christianson has no disclosures. 

Dr. Christianson scans the journals, so you don’t have to!
Dr. Christianson scans the journals, so you don’t have to!

Mindy S. Christianson, MD
Which technique is superior for laparoscopic myomectomy (LM) -  single-port laparoscopy or traditional three-port laparoscopy? Jiang et al examined this question in a retrospective review in Frontiers in Oncology. Sixty patients underwent single-port LM and 60 were treated with traditional 3-port LM. Single-port LM outperformed 3-port LM in the following areas: faster specimen removal time, quicker postoperative ambulation time, shorter hospital stay (all P < .05). Patients reported greater abdominal scar satisfaction scores with single-port versus 3-port LM (4.17 vs 3.47; P = .00). Intraoperative blood loss was similar in both groups (P > .05). In terms of clinical care, patients can be counseled that single-port LM for treating certain uterine fibroids demonstrated faster recovery and higher patient satisfaction in this study, although larger randomized trials are needed.

Mahalingam et al in the Journal of Maternal-Fetal & Neonatal Medicine reported the risk of preterm birth among women with uterine fibroids who underwent myomectomy versus those who did not prior to pregnancy. In this retrospective cohort study, the team evaluated 290 women with a viable intrauterine pregnancy and history of uterine fibroids and compared two groups: 70 with history of a prior myomectomy and 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation. The team found that women who underwent prior myomectomy versus those who did not were more likely to deliver preterm < 37 weeks gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks gestation; P = .02). Patients with history of myomectomy had a higher C-section rate (88% vs 53%, P < 0.001). However, when the authors controlled for late preterm pre-labor C-sections recommended by physicians in the myomectomy cohort (n=5), the difference in preterm birth was not significant between the groups.

Lee et al reported that MRI can potentially predict the benefit of GnRH-agonist treatment prior to for large fibroids. In this retrospective analysis published in Acta Radiologica, 30 patients with large uterine fibroids received GnRH agonist prior to uterine artery embolization (UAE) with MRI evaluation before and after treatment. Indications for GnRH-agonist treatment (monthly 3.75 mg leuprolide acetate injections) included intramural or subserosal fibroids > 10 cm in diameter or pedunculated submucosal fibroids > 8 cm, as well as contrast enhancement observed on T1-weighted (T1W) images. Mean maximum fibroid diameter was 11.1 + 1.9 cm and mean number of GnRH-agonist injections received was 2.8. Signal intensity (SI) of the predominant fibroid on T2-weighted (T2W) images was referenced to the SI of the rectus abdominus muscle (F/R). For predicting a volume reduction rate of the large fibroid of >50%, the optimal cut-off value of F/R was 2.58 (sensitivity 80%, specificity 80%). Likewise, large fibroids with a volume rate reduction of <30% had an optimal cut-off volume of 1.69 (sensitivity 100%, specificity 70%). From a clinical perspective, both surgeons and radiologists could use SI of the predominant fibroid on T2W to predict response to GnRH agonist pretreatment.

Mindy S. Christianson, MD
Which technique is superior for laparoscopic myomectomy (LM) -  single-port laparoscopy or traditional three-port laparoscopy? Jiang et al examined this question in a retrospective review in Frontiers in Oncology. Sixty patients underwent single-port LM and 60 were treated with traditional 3-port LM. Single-port LM outperformed 3-port LM in the following areas: faster specimen removal time, quicker postoperative ambulation time, shorter hospital stay (all P < .05). Patients reported greater abdominal scar satisfaction scores with single-port versus 3-port LM (4.17 vs 3.47; P = .00). Intraoperative blood loss was similar in both groups (P > .05). In terms of clinical care, patients can be counseled that single-port LM for treating certain uterine fibroids demonstrated faster recovery and higher patient satisfaction in this study, although larger randomized trials are needed.

Mahalingam et al in the Journal of Maternal-Fetal & Neonatal Medicine reported the risk of preterm birth among women with uterine fibroids who underwent myomectomy versus those who did not prior to pregnancy. In this retrospective cohort study, the team evaluated 290 women with a viable intrauterine pregnancy and history of uterine fibroids and compared two groups: 70 with history of a prior myomectomy and 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation. The team found that women who underwent prior myomectomy versus those who did not were more likely to deliver preterm < 37 weeks gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks gestation; P = .02). Patients with history of myomectomy had a higher C-section rate (88% vs 53%, P < 0.001). However, when the authors controlled for late preterm pre-labor C-sections recommended by physicians in the myomectomy cohort (n=5), the difference in preterm birth was not significant between the groups.

Lee et al reported that MRI can potentially predict the benefit of GnRH-agonist treatment prior to for large fibroids. In this retrospective analysis published in Acta Radiologica, 30 patients with large uterine fibroids received GnRH agonist prior to uterine artery embolization (UAE) with MRI evaluation before and after treatment. Indications for GnRH-agonist treatment (monthly 3.75 mg leuprolide acetate injections) included intramural or subserosal fibroids > 10 cm in diameter or pedunculated submucosal fibroids > 8 cm, as well as contrast enhancement observed on T1-weighted (T1W) images. Mean maximum fibroid diameter was 11.1 + 1.9 cm and mean number of GnRH-agonist injections received was 2.8. Signal intensity (SI) of the predominant fibroid on T2-weighted (T2W) images was referenced to the SI of the rectus abdominus muscle (F/R). For predicting a volume reduction rate of the large fibroid of >50%, the optimal cut-off value of F/R was 2.58 (sensitivity 80%, specificity 80%). Likewise, large fibroids with a volume rate reduction of <30% had an optimal cut-off volume of 1.69 (sensitivity 100%, specificity 70%). From a clinical perspective, both surgeons and radiologists could use SI of the predominant fibroid on T2W to predict response to GnRH agonist pretreatment.

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Clinical Edge Journal Scan: Uterine Fibroids November 2021
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Uterine fibroid: Prior myomectomy linked to higher risk for preterm birth

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Key clinical point: The risk for preterm birth (PTB) was higher among women who underwent preconception myomectomy to treat uterine fibroids vs women with fibroids who did not undergo prior myomectomy.

Major finding: Women who underwent prior myomectomy vs those who did not were more likely to experience PTB at less than 37 weeks’ gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks’ gestation; P = .02).

Study details: Findings are from a retrospective cohort study including 290 women with a viable intrauterine pregnancy, of which 70 had a prior myomectomy and the remaining 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation.

Disclosures: This study was funded by the National Institute of Child Health and Human Development. The authors reported no conflict of interests.

Source: Mahalingam M et al. J Matern Fetal Neonatal Med. 2021 Oct 6. doi: 10.1080/14767058.2021.1984424.

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Key clinical point: The risk for preterm birth (PTB) was higher among women who underwent preconception myomectomy to treat uterine fibroids vs women with fibroids who did not undergo prior myomectomy.

Major finding: Women who underwent prior myomectomy vs those who did not were more likely to experience PTB at less than 37 weeks’ gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks’ gestation; P = .02).

Study details: Findings are from a retrospective cohort study including 290 women with a viable intrauterine pregnancy, of which 70 had a prior myomectomy and the remaining 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation.

Disclosures: This study was funded by the National Institute of Child Health and Human Development. The authors reported no conflict of interests.

Source: Mahalingam M et al. J Matern Fetal Neonatal Med. 2021 Oct 6. doi: 10.1080/14767058.2021.1984424.

Key clinical point: The risk for preterm birth (PTB) was higher among women who underwent preconception myomectomy to treat uterine fibroids vs women with fibroids who did not undergo prior myomectomy.

Major finding: Women who underwent prior myomectomy vs those who did not were more likely to experience PTB at less than 37 weeks’ gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks’ gestation; P = .02).

Study details: Findings are from a retrospective cohort study including 290 women with a viable intrauterine pregnancy, of which 70 had a prior myomectomy and the remaining 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation.

Disclosures: This study was funded by the National Institute of Child Health and Human Development. The authors reported no conflict of interests.

Source: Mahalingam M et al. J Matern Fetal Neonatal Med. 2021 Oct 6. doi: 10.1080/14767058.2021.1984424.

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