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Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Sponsor: Jean Dubuisson
Summary
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery. The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation/aspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.
Official title: Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2024-01-01
Completion Date
2027-04-03
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
Elective cystectomy
Adnexal cyst removal for presumed benign adnexal pathology.
Elective oophorectomy
Ovarian removal for presumed benign adnexal pathology.
Elective salpingectomy
Tubal removal for presumed benign adnexal pathology.
Elective tubal sterilization
Tubal obstruction as a definitive contraceptive method (tubal cauterization with or without sectioning, partial or total removal of both tubes, or obstruction with small clips/ligatures).
Locations (1)
Geneva University Hospital
Geneva, Switzerland