Gynecologic Surgery
Conditions
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.
Interventions
PROCEDURElaparoscopy
tubal ligation by laparoscopy or vnotes technique
PROCEDUREvnotes
tubal ligation by laparoscopy or vnotes technique
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniques
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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. |
| 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). |
| 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). |
| 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. |
| 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. |
Countries
France
Outcome results
None listed