RecruitingNot ApplicableNCT05761275

Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach

Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial


Sponsor

Jean Dubuisson

Enrollment

62 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Elective cystectomy, a procedure called Elective oophorectomy, and others for people with adnexal cyst, adnexal diseases, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREElective cystectomy

Adnexal cyst removal for presumed benign adnexal pathology.

PROCEDUREElective oophorectomy

Ovarian removal for presumed benign adnexal pathology.

PROCEDUREElective salpingectomy

Tubal removal for presumed benign adnexal pathology.

PROCEDUREElective 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

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NCT05761275


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