Akila Subramaniam1, Christina T Blanchard, Britt K Erickson, Jeff Szychowski, Charles A Leath, Joseph R Biggio, Warner K Huh. 1. Center for Women's Reproductive Health, Department of Obstetrics and Gynecology, and the Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Gynecologic Oncology, University of Minnesota, Minneapolis, Minnesota; and Ochsner Health System, New Orleans, Louisiana.
Abstract
OBJECTIVE: To evaluate the feasibility of salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility. METHODS: We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. If salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided α of 0.05. Analysis was by intent to treat. RESULTS: Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized-40 to salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the salpingectomy group (median 10 [interquartile range 5-25] compared with 5 [interquartile range 5-10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups. CONCLUSION: Adding 15 minutes to total operative times, salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT02374827.
RCT Entities:
OBJECTIVE: To evaluate the feasibility of salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility. METHODS: We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. If salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided α of 0.05. Analysis was by intent to treat. RESULTS: Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized-40 to salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the salpingectomy group (median 10 [interquartile range 5-25] compared with 5 [interquartile range 5-10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups. CONCLUSION: Adding 15 minutes to total operative times, salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT02374827.
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