NCT05031182

Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

Conditions

• Hysterectomy
• Laparoscopy
• vNOTES

Interventions

Type	Name	Description
PROCEDURE	Laparoscopy	The hysterectomy is performed by laparoscopy as described in the EMC.
PROCEDURE	vNOTES	The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.

Timeline

• Start date: 2021-10-11
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2021-09-01
• Last updated: 2026-02-02

Locations

2 sites across 1 country: France