Protocol for a study comparing the efficacy of hysterectomy in patients with enlarged uterus via TU-LESS and vNOTES: a single-blind, prospective randomised clinical trial.

Abstract

Minimally invasive techniques have been widely adopted for hysterectomy, including Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). However, their efficacy in patients with an enlarged uterus (≥280 g) remains not fully illustrated due to surgical complexity. We will compare the perioperative outcomes and recovery profiles of TU-LESS and vNOTES of this population in this study. This single-blinded, two-arm, parallel-group, randomised controlled trial will take place in West China Second University Hospital. A total of 210 women with benign or precancerous uterine enlargement undergoing total hysterectomy (±salpingectomy/adnexectomy) will be randomised (1:1) to TU-LESS or vNOTES. The trial will span 2 years, including a follow-up of half a year. The primary outcomes will be the proportions achieving the indices of enhanced recovery after surgery respectively, including liquid diet tolerance, flatus passage, unassisted urination and mobility, during 24 hours after surgery and discharge within 2 days. Secondary outcomes include pain scores, operative duration, blood loss, complications, scar quality, analgesic use and pelvic/sexual function. Data collection occurs at baseline, perioperatively and 3/6 months postoperatively. This study was approved by the Ethics Committee of West China Second University Hospital (2023 medical scientific research for ethical approval No.321). Written informed consent will be collected from all participants. Results will be shared through publication in peer-reviewed journals and presentations at conferences. NCT06663553.