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TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05910385
Collaborator
(none)
140
Enrollment
2
Locations
2
Arms
42.1
Anticipated Duration (Months)
70
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopy
  • Procedure: vnotes
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniquesRandomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniques
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial
Actual Study Start Date :
May 23, 2022
Actual Primary Completion Date :
May 23, 2022
Anticipated Study Completion Date :
Nov 23, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: laparoscopic

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

Procedure: vnotes
tubal ligation by laparoscopy or vnotes technique

Outcome Measures

Primary Outcome Measures

  1. quality of sexual life [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 Outcome Measures

  1. characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes) [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 [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. [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. [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 [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 [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 [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 [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Clermont-Ferrand Clermont-Ferrand France 63000
2 CH d'Issoire Issoire France 63500

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Sandra Curinier, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT05910385
Other Study ID Numbers:
  • RBHP 2021 CURINIER 2
  • 2021-A02263-38
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 18, 2023