TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES) (TULIPES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Surgery
• 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: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Sandra Curinier
    • Sub-Investigator: Anne-Sophie Gremeau
    • Contact: Lise Laclautre; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr
    • Sub-Investigator: Sandrine Campagne Loiseau
  • Issoire, France, 63500
    • Recruiting
    • CH d'Issoire
    • Principal Investigator: Clément Bruhat
    • Contact: Clément Bruhat; Email: cbruhat@ch-issoire.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laparoscopic	Procedure: laparoscopy; tubal ligation by laparoscopy or vnotes technique
Experimental: vnotes	Procedure: vnotes; tubal ligation by laparoscopy or vnotes technique

What is the study measuring?

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

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): May 23, 2022
• Primary Completion (Actual): May 23, 2022
• Study Completion (Estimated): November 23, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RBHP 2021 CURINIER 2; 2021-A02263-38 (Other Identifier: ANSM)

Drug and device information, study documents

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