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

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.

Study Overview

• Status: Recruiting
• Conditions: Hysterectomy; Laparoscopy; vNOTES
• Intervention / Treatment: Procedure: Laparoscopy; Procedure: vNOTES

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Sandra Curinier
    • Contact: Lise Laclautre
  • Issoire, France
    • Recruiting
    • CH d'Issoire
    • Principal Investigator: Clément Bruhat
    • Contact: Lise Laclautre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Laparoscopy; In this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday.	Procedure: Laparoscopy; The hysterectomy is performed by laparoscopy as described in the EMC.
Active Comparator: 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.	Procedure: vNOTES; The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications per or post Operative	Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection	one month after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Sandra CURINIER, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RBHP 2021 CURINIER; 2021-A01218-33 (Other Identifier: 2021-A01218-33)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No