Surgical outcomes and postoperative sexual function after vNOTES versus TU-LESS ovarian cystectomy: a randomized controlled trial.

OBJECTIVE

To compare surgical outcomes and sexual function after Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus transumbilical laparoendoscopic single-site surgery (TU-LESS) ovarian cystectomy.

DESIGN

Randomized controlled trial.

SETTING

A university-affiliated tertiary women's and children's hospital.

POPULATION: 160 women with benign ovarian cysts randomized 1:1 to vNOTES or TU-LESS.

METHODS

After written informed consent, candidates underwent two-step eligibility assessment before and after anesthesia to confirm suitability for both approaches. Participants were then randomly assigned to vNOTES or TU-LESS ovarian cystectomy. Perioperative outcomes were prospectively collected. Pain was assessed using a visual analogue scale at 12, 24, and 48 h. Cosmetic satisfaction was evaluated at 1 month, and sexual function was assessed preoperatively and at 3-6 months using the Female Sexual Function Index.

MAIN OUTCOME MEASURES: Conversion, operative outcomes, complications, recovery, pain, cosmetic satisfaction, and sexual function.

RESULTS

No conversion occurred. Intraoperative complications, operative time, blood loss, postoperative complications (5.0% vs 3.8%), rescue analgesic use, wound events, incisional hernia, and postoperative FSFI scores between 3rd and 6th postoperative months were comparable between vNOTES and TU-LESS groups. vNOTES yielded lower pain scores at 12, 24, and 48 h, shorter total and postoperative hospital stay, and higher cosmetic satisfaction (all p < 0.001).

CONCLUSION

vNOTES ovarian cystectomy demonstrated perioperative safety and postoperative sex function comparable to TU-LESS, while offering superior early postoperative pain control, shorter hospitalization, and better cosmetic satisfaction.

TRIAL REGISTRATION: ChiCTR2100053483, registered on 22 November 2021 ( https://www.chictr.org.cn/showprojEN.html?proj=136407 ).