To estimate whether performance of salpingectomy compared with standard tubal ligation for sterilization at the time of cesarean delivery increases operating time or complication rates.
A randomized controlled noninferiority trial was performed at a single academic institution. Women undergoing planned cesarean delivery who desired sterilization were randomized to salpingectomy or standard tubal ligation. The primary outcome was length of time of the sterilization procedure, with the noninferiority margin set at 5 minutes. With a one-sided independent sample t test, to achieve a power of 90% with an α of 0.05, 18 women needed to complete each intervention.
Forty-four women were enrolled, with 19 successfully undergoing salpingectomy and 18 undergoing standard tubal ligation. Salpingectomy could not be completed in 1 of 20 patients (as a result of adhesions). Baseline demographics were equivalent between groups. Salpingectomy procedure time was noninferior to standard tubal ligation, with a mean difference of 0.5 minutes, with a mean sterilization procedure time of 5.6 minutes in the salpingectomy group and 6.1 minutes in the standard tubal ligation group (P <.05, one-sided 95% CI upper bound 1.8 minutes). There was no difference between cesarean delivery with salpingectomy compared with cesarean delivery with standard tubal ligation in median total operating time (60 vs 68 minutes, P=.34) or estimated blood loss (600 vs 700 mL, P=.09). No patients in either group required reoperation or readmission.
Salpingectomy procedure time was not longer than standard tubal ligation during cesarean delivery, with a mean difference of 30 seconds. There was a high completion rate for salpingectomy (95%) and no apparent increase in complications.
Salpingectomy compared with standard tubal ligation at cesarean delivery is noninferior with regard to procedure time.
Departments of Obstetrics and Gynecology and Public Health Sciences, University of Virginia, and the Clinical Trials Office, University of Virginia School of Medicine, Charlottesville, Virginia.
Corresponding author: Christine Garcia, MD, MPH, Department of Obstetrics and Gynecology, University of Virginia, 1215 Lee Street, Charlottesville, VA 22902; email: email@example.com.
Funding for this study was provided by the Obstetrics and Gynecology Department at the University of Virginia.
Financial Disclosure The authors did not report any potential conflicts of interest.
Each author has indicated that he or she has met the journal's requirements for authorship.
Received February 4, 2018. Received in revised form March 21, 2018. Accepted March 29, 2018.