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

Study Overview
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Brief Summary
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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.

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

Conditions
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Laparoscopy, vNOTES, Hysterectomy

Intervention / Treatment
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* Procedure: Laparoscopy
* Procedure: vNOTES


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |