Clinical Trial

vNOTES vs Laparoscopic Hysterectomy: Randomized Trial on Pain and Recovery"

Study acronym: VNOTES-TLH
Completed
View on ClinicalTrials.gov →
Summary
This study is a prospective, randomized controlled trial comparing two different minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to evaluate whether vNOTES provides better postoperative comfort and recovery by reducing pain, lowering opioid analgesic requirements, and improving early recovery outcomes. Approximately 80 women undergoing elective hysterectomy will be randomly assigned to either vNOTES or TLH. All surgeries will be performed under standardized general anesthesia by the same experienced surgical team. Postoperative pain management will follow an identical protocol for all patients. Primary outcomes include postoperative pain scores (at 12 and 24 hours) and total opioid consumption. Secondary outcomes include Quality of Recovery-15 (QoR-15) scores, fatigue scores, time to first mobilization, time to first flatus, and length of hospital stay. The results of this study may help identify which hysterectomy technique offers better patient-centered recovery and postoperative comfort.
Protocol Amendment History 4 changes
critical Trial completed 2026-04-16
notable Enrollment increased: 56 -> 90 participants 2026-04-16
notable Primary completion pushed: 2026-02-25 -> 2026-04-09 2026-04-16
minor Completion pushed: 2026-02-26 -> 2026-04-10 2026-04-16
Trial Details
NCT Number NCT07306507
Lead Sponsor Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Conditions Hysterectomy
Enrollment 90 participants
Start Date 2026-01-08
Primary Completion 2026-04-09 (estimated)
Study Completion 2026-04-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-15