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 a 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%, P5.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4629.1 compared with 60.0623.3 minutes, P5.004). 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 20-27 |
| Number of pages | 8 |
| Journal | Obstetrics and gynecology |
| Volume | 132 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2018 |
Bibliographical note
Funding Information:Salpingectomy at Cesarean for Ovarian Cancer Reduction was a randomized clinical trial conducted at the University of Alabama at Birmingham. The trial was registered with clinicatrials.gov (NCT02374827) and approved by our institutional review board (#F140630003) with approval valid throughout the course of the trial. Written informed consent was obtained from all participants in the trial. Funding was provided in part by the Debra Kogan Lyda Memorial Ovarian Cancer Fund. An independent data and safety monitoring board oversaw the trial. The first author takes responsibility for the accuracy, completeness, and fidelity to the trial protocol.
Funding Information:
Supported by the Debora Kogan Lyda Ovarian Cancer Memorial Fund. Funding support was also provided in part by National Institutes of Health: 5K12HD0012580-15, U10 C180855, and 3P30CA013148-43S3 to Charles A. Leath*%blankline%*
Funding Information:
Supported by the Debora Kogan Lyda Ovarian Cancer Memorial Fund. Funding support was also provided in part by National Institutes of Health: 5K12HD0012580-15, U10 C180855, and 3P30CA013148-43S3 to Charles A. Leath.
Publisher Copyright:
© 018 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
