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TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Gynecologic Surgery

Treatments

Procedure: laparoscopy
Procedure: vnotes

Study type

Interventional

Funder types

Other

Identifiers

NCT05910385
RBHP 2021 CURINIER 2
2021-A02263-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

laparoscopic
Active Comparator group
Treatment:
Procedure: laparoscopy
vnotes
Experimental group
Treatment:
Procedure: vnotes

Trial contacts and locations

2

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Central trial contact

Lise LACLAUTRE

Data sourced from clinicaltrials.gov

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