Skip to main content
OpenTrials
Completed

NCT Number: NCT05910385

TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gynecologic Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopy

Procedure

tubal ligation by laparoscopy or vnotes technique

vNOTES

Procedure

tubal ligation by laparoscopy or vnotes technique

Primary outcomes

  1. quality of sexual life

    Time frame: 6 months

    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).

Secondary outcomes

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

    Time frame: 6 months

    • 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.

  2. postoperative pain

    Time frame: 6 months

    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).

  3. consumption of peroperative analgesics.

    Time frame: 6 months

    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).

  4. consumption of postoperative analgesics.

    Time frame: 6 months

    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).

  5. per and post-operative complications

    Time frame: 6 months

    • 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. patient satisfaction

    Time frame: 6 months

    • 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).

  7. quality of life after surgery

    Time frame: 6 months

    • 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).

  8. number of days of sick leave

    Time frame: 6 months

    • Compare the number of days of sick leave, depending on whether it is performed by abdominal laparoscopy or by vNOTES.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: TULIPES

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.