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

Not Applicable

Recruiting

• Conditions: Hysterectomy; vNOTES; Laparoscopy
• Interventions: Procedure: Laparoscopy; Procedure: vNOTES

• Registration Number: NCT05031182
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-01
• Study Start: 2021-10-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy.
• Able to give informed consent to participate in research.
• Affiliation to a Social Security scheme.

Exclusion Criteria

• Pregnant or breastfeeding women
• Contraindication to the laparoscopic approach
• Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection
• Indications for another concomitant surgical procedure (other than procedure on the appendix)
• Indication of hysterectomy for malignant lesion.
• Any concomitant pathology deemed incompatible with the study.
• COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery.
• Adult patient protected, under guardianship or curatorship or legal safeguard
• Refusal of participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopy	Laparoscopy	In this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday.
vNOTES	vNOTES	In this Arm, patient will have the hysterectomy by vNOTES (vaginal natural orifices Transluminal surgery). It's the new type of surgery that we want prove the no-inferiority.

Primary Outcome Measures

Name	Time	Method
Complications per or post Operative	one month after surgery	Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection

Secondary Outcome Measures

Name	Time	Method
Duration of operation	one day	From skin opening to skin or vaginal closure
Duration of work stoppage	one month	Patients will inquire if they needed to prolong the sick leave.
Assessment of quality of life	Six month	Respond to SF-36 questionnaire to assess and compare quality of life before and after surgery
Assessment of satisfaction	Six month	Respond to FSFI questionnaire to assess and compare sexuality before and after surgery
Measure of pain	Until one month	Quantification of postoperative pain: 6 hours, 24 hours, day 2, 5, 7, 14 and at one month

Trial Locations

Locations (2)

CHU clermont-ferrand; 🇫🇷 Clermont-Ferrand, France

CH d'Issoire; 🇫🇷 Issoire, France