TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

Study Overview
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Brief Summary
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The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Participants will answer on the FSFI-19 questionnaire and quality of sexual life will be evaluated according to the score obtained at 6 months post-operative compared to pre-operative.

Official Title
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Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial

Conditions
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Gynecologic Surgery

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 tubal ligation by total salpingectomy or tubal section coagulation, sexually active at the time of inclusion Able to give informed consent to participate in research Affiliated to a social security system. Exclusion Criteria: Current pregnancy or breastfeeding Indications of another concomitant surgical procedure (other than procedure on the appendix) History of upper genital infection Proven or suspected rectovaginal endometriosis on clinical examination History of rectal surgery Virgin patient Any concomitant pathology deemed incompatible with the study. Uncured COVID or SARS-COv2 positivity dated less than 3 days prior to surgery. Protected adult patient, under guardianship or curatorship Patients not affiliated to the social security system Patients who do not speak French Patients under legal protection Refusal to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Randomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniques
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic<br> | Procedure: laparoscopy<br>* tubal ligation by laparoscopy or vnotes technique<br>|
| Experimental: vnotes<br> | Procedure: vnotes<br>* tubal ligation by laparoscopy or vnotes technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of sexual life | To compare, on the basis of a non-inferiority hypothesis, the quality of sexual life at 6 months after tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, using the Female Sexual Function Index - 19 (FSFI-19) questionnaire (19 questions with 6 possible answers for each, with scores ranging from 0=worse outcome to 5=better outcome). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes) | - Compare the characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes), depending on whether it is performed by abdominal laparoscopy or by vNOTES. | 6 months | 
| postoperative pain | Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of postoperative pain, using EVA Scale (from 0 to 10). | 6 months | 
| consumption of peroperative analgesics. | Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of consumption of peroperative analgesics (e.g. name of the analgesics, dose and duration of intake in days). | 6 months | 
| consumption of postoperative analgesics. | Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of consumption of postoperative analgesics (e.g. name of the analgesics, dose and duration of intake in days). | 6 months | 
| per and post-operative complications | - Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in terms of per and post-operative complications. | 6 months | 
| patient satisfaction | - Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of patient satisfaction (Very dissatisfied, Moderately dissatisfied, Neither satisfied nor dissatisfied, Moderately satisfied, Very satisfied). | 6 months | 
| quality of life after surgery | - Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of patient quality of life after surgery, using EQ-5D-5L questionnaire (with five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems). | 6 months | 
| number of days of sick leave | - Compare the number of days of sick leave, depending on whether it is performed by abdominal laparoscopy or by vNOTES. | 6 months |