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
Introduction: 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.
Methods and analysis: 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.
Ethics and dissemination: This study was approved by the Ethics Committee of West China Second University Hospital (2023 medical…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 210 participants or records.
Read the paper
Related studies
- Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial
- Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial
- Comparison of the Post-Caesarean Analgesic Effect of Adding Dexmedetomidine to Paracetamol and Ketorolac: A Randomized Clinical Trial
- A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions
- An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients
- Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.