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

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.

Conditions

• Gynecologic Disease
• Adnexal Mass
• Adnexal Cyst
• Sexuality
• Adnexal Diseases
• Sexual Dysfunction
• Quality of Life
• Pathology
• Dyspareunia
• Pelvic Pain
• Complication

Interventions

PROCEDURE

Elective cystectomy

Adnexal cyst removal for presumed benign adnexal pathology.

PROCEDURE

Elective oophorectomy

Ovarian removal for presumed benign adnexal pathology.

PROCEDURE

Elective salpingectomy

Tubal removal for presumed benign adnexal pathology.

PROCEDURE

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).

Sponsors & Collaborators

• Jean Dubuisson

  lead OTHER

Principal Investigators

• Jean Dubuisson · University Hospital, Geneva

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2026-06-30

Completion

2027-04-03

Countries

• Switzerland

Study Locations