TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2025-11-18

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.

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Detailed Description

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Conditions

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Gynecologic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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laparoscopic

Group Type ACTIVE_COMPARATOR

laparoscopy

Intervention Type PROCEDURE

tubal ligation by laparoscopy or vnotes technique

vnotes

Group Type EXPERIMENTAL

vnotes

Intervention Type PROCEDURE

tubal ligation by laparoscopy or vnotes technique

Interventions

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laparoscopy

tubal ligation by laparoscopy or vnotes technique

Intervention Type PROCEDURE

vnotes

tubal ligation by laparoscopy or vnotes technique

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No