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

NCT07306507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Hysterectomy

Interventions

PROCEDURE

vNOTES Hysterectomy

Transluminal endoscopic hysterectomy is performed through a vaginal natural opening via transvaginal access using a self-adhering vaginal port.

PROCEDURE

Total Laparoscopic Hysterectomy

It is a conventional total laparoscopic hysterectomy performed using an umbilical cord port and two accessory trocars.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    lead OTHER

Principal Investigators

  • Fatma Acil, M.D. · Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2026-04-09
Completion
2026-04-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306507 on ClinicalTrials.gov