TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

Last updated: August 26, 2024
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

laparoscopy

vnotes

Clinical Study ID

NCT05910385
RBHP 2021 CURINIER 2
2021-A02263-38
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult woman, eligible for tubal ligation by total salpingectomy or tubal sectioncoagulation, sexually active at the time of inclusion

  • Able to give informed consent to participate in research

  • Affiliated to a social security system.

Exclusion

Exclusion Criteria:

  • Current pregnancy or breastfeeding

  • Indications of another concomitant surgical procedure (other than procedure on theappendix)

  • 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 Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: laparoscopy
Phase:
Study Start date:
May 23, 2022
Estimated Completion Date:
November 23, 2025

Connect with a study center

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CH d'Issoire

    Issoire, 63500
    France

    Active - Recruiting

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