TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

Gynecologic Surgery Clinical Trial

— TULIPES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910385
• Other study ID #: RBHP 2021 CURINIER 2
• Secondary ID: 2021-A02263-38
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: November 23, 2025

Study information

• Verified date: March 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 23, 2025
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Surgery

Intervention

Procedure:
• laparoscopy
tubal ligation by laparoscopy or vnotes technique
• vnotes
tubal ligation by laparoscopy or vnotes technique

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CH d'Issoire	Issoire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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