TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

University Hospital, Clermont-Ferrand140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Gynecologic Surgery

Interventions

laparoscopyPROCEDURE

tubal ligation by laparoscopy or vnotes technique

vnotesPROCEDURE

tubal ligation by laparoscopy or vnotes technique

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CH d'Issoire

Issoire, France

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

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).

Time frame: 6 months

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).

Time frame: 6 months

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).

Time frame: 6 months

per and post-operative complications

Data from ClinicalTrials.gov

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