TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

NCT05910385 | Completed

• 2 other identifiers: RBHP 2021 CURINIER 22021-A02263-38
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gynecologic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes)

  6 months

• postoperative pain

  6 months

• consumption of peroperative analgesics.

  6 months

• consumption of postoperative analgesics.

  6 months

• per and post-operative complications

  6 months

Study Arms (2)

laparoscopic

ACTIVE COMPARATOR

Procedure: laparoscopy

vnotes

EXPERIMENTAL

Procedure: vnotes

Interventions

laparoscopy PROCEDURE

tubal ligation by laparoscopy or vnotes technique

laparoscopic

vnotes PROCEDURE

tubal ligation by laparoscopy or vnotes technique

vnotes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give informed consent to participate in research
• Affiliated to a social security system.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CH d'Issoire

Issoire, 63500, France

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sandra Curinier

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniques

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: June 18, 2023
• Study Start: May 23, 2022
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (2)