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

NCT07306507 | Completed

• 1 other identifier: 11/7/2025-705
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vNOTES; Total Laparoscopic Hysterectomy; Postoperative Pain; Enhanced Recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity (NRS)

  Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.

  At 12 and 24 hours postoperatively

Secondary Outcomes (9)

• Need for Rescue Analgesia Within 24 Hours

  First 24 postoperative hours

• Time to First Mobilization

  From the end of surgery until the first ambulation out of bed, assessed up to 48 hours postoperatively.

• Time to First Flatus

  Time Frame: From the end of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days postoperatively or until hospital discharge, whichever comes first.

• Length of Postoperative Hospital Stay

  Time Frame: From the day of surgery until hospital discharge, assessed up to 30 days postoperatively or until discharge, whichever comes first.

• Change in QoR-15 Score from Baseline to 24 Hours

  Time Frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively

Study Arms (2)

vNOTES Group

EXPERIMENTAL

Patients undergo vaginal natural orifice transluminal endoscopic hysterectomy (vNOTES) using a transvaginal access port with a maximum pneumoperitoneum pressure not exceeding 15 mmHg.

Procedure: vNOTES Hysterectomy

TLH Group

ACTIVE COMPARATOR

Patients undergo conventional total laparoscopic hysterectomy using a camera port and accessory trocars from the umbilicus, and pneumoperitoneum is maintained at a pressure not exceeding 15 mmHg.

Procedure: Total Laparoscopic Hysterectomy

Interventions

vNOTES Hysterectomy PROCEDURE

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

vNOTES Group

Total Laparoscopic Hysterectomy PROCEDURE

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

TLH Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 to 75 years
• ASA physical status I-II
• Scheduled for elective laparoscopic hysterectomy (benign indications such as myoma uteri, adenomyosis, endometrial hyperplasia)
• Able to understand study procedures and provide written informed consent
• Able to complete postoperative questionnaires (QoR-15 and Fatigue Assessment Scale)

You may not qualify if:

• ASA III-IV status
• Severe cardiopulmonary disease or contraindication to general anesthesia
• Coagulopathy or bleeding disorders
• Active pelvic infection
• History of extensive pelvic or abdominal surgery complicating minimally invasive access
• Cognitive impairment or inability to complete questionnaires
• Conversion to laparotomy
• Known allergy or intolerance to study medications (paracetamol, tramadol)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Turkey, 21070, Turkey (Türkiye)

Location

Related Publications (1)

• Fang S, Xia Y, Jin J, Zhang J, Lu L. Comparison of Surgical Outcomes Between Vaginally Assisted NOTES Hysterectomy and Laparoscopic Hysterectomy in Primary Hospitals: A Prospective Cohort Study. J Invest Surg. 2025 Dec;38(1):2515054. doi: 10.1080/08941939.2025.2515054. Epub 2025 Jun 10.

  PMID: 40492370 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fatma Acil, M.D.

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators responsible for postoperative data collection and analysis and outcome assessors were blinded to group allocation. These investigators were not involved in the surgical or anesthetic management of the patients. Due to the nature of the surgical procedures, blinding of participants and care providers was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to undergo either vNOTES hysterectomy or conventional total laparoscopic hysterectomy. Each participant receives only one of the two surgical interventions, and both groups are followed in parallel for outcome assessment.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 29, 2025
• Study Start: January 8, 2026
• Primary Completion: April 9, 2026
• Study Completion: April 10, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

TU (1)