McCall Culdoplasty during Total Laparoscopic Hysterectomy: A Pilot Randomized Controlled Trial

Abstract

Study objective: To assess the feasibility and safety of a McCall culdoplasty at the time of total laparoscopic hysterectomy and to evaluate the differences in the total vaginal length, vaginal apex during Valsalva, and sexual function 12 months after McCall culdoplasty compared with standard cuff closure.

Design: A pilot randomized controlled, single-masked trial (Canadian Task Force classification I).

Setting: An academic tertiary care hospital.

Patients: Women undergoing total laparoscopic hysterectomy for benign indications from June 2013 to December 2013.

Interventions: Women were randomized (1:1) to McCall culdoplasty followed by standard cuff closure versus standard cuff closure. Patients underwent Pelvic Organ Prolapse Quantification examination and completed the Female Sexual Function Index immediately before surgery and at 6 months and 12 months postoperatively. The primary outcome was the operative time. Secondary outcomes included estimated blood loss, complications, total vaginal length, vaginal apex during Valsalva, and sexual function.

Measurements and main results: This study included 50 patients. The groups were similar in terms of preoperative and surgical characteristics. The operative time did not differ between the groups. The estimated blood loss and complications were also similar. The loss to follow-up was similar in both groups. Changes in the total vaginal length, vaginal apex during Valsalva, sexual function, and pain with intercourse did not differ between the groups.

Conclusion: In this pilot study, the addition of McCall culdoplasty to standard cuff closure during total laparoscopic hysterectomy was not associated with an increase in operative time, estimated blood loss, or surgical complications. No differences in the total vaginal length or vaginal apex during Valsalva were observed at the 12-month follow-up. There were no differences in sexual dysfunction or dyspareunia. Given the well-established risk reduction for the development of apical prolapse with McCall culdoplasty during vaginal hysterectomy, this procedure may be a feasible and safe addition to total laparoscopic hysterectomy.

Trial registration: ClinicalTrials.gov NCT01840176.

Keywords: Apical prolapse; Apical support; Uterosacral ligament suspension.