Apical Support After Benign Laparoscopic Hysterectomy: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques.

Abstract

Introduction and hypothesis: The route of vaginal cuff closure after laparoscopic hysterectomy has not been standardized. This study was designed to compare pelvic floor support after vaginal or laparoscopic cuff closure. The authors hypothesized that laparoscopic closure would be superior.

Methods: This randomized controlled trial included women undergoing a benign total laparoscopic hysterectomy. Exclusion criteria included concurrent prolapse procedure, malignancy, and a pelvic organ prolapse quantitation system (POPQ) point C greater than -4. Preoperative POPQ exams were performed by blinded Urogynecologists. Patients were randomized to vaginal or laparoscopic cuff closure on the day of surgery. POPQ exams were repeated by blinded Urogynecologists at 6-8 weeks and 1 year postoperatively. Using a corrected alpha of 0.05 and power 0.8 to detect a 1.75 cm difference, the required sample size was 62 with 31 patients per group. Categorical variables were compared using the chi-squared or Fisher exact tests. Continuous variables were compared using a two-tailed t-test.

Results: Fifty-seven patients were enrolled. Forty-four patients completed 6-8 week follow-up, and 33 patients were evaluated at 1 year. The calculated sample size was not obtained as patient enrollment and retention were impacted by the COVID-19 pandemic. The mean difference of point C between laparoscopic and vaginal closure was 0.98 cm and 1.24 cm, respectively, at 6-8 weeks (p = .55), and 1.22 cm and 1.63 cm, respectively, at 1 year (p = .48). Mean differences for all other POPQ exam points and complication rates were nonsignificant.

Conclusions: For up to 1 year postop, there is no significant difference in apical support when comparing laparoscopic to vaginal cuff closure.