Actively Recruiting
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Led by Jean Dubuisson · Updated on 2025-03-27
62
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged from 18 to 70 years
- Ability to understand the study and provide oral and written consent
- Engaged in heterosexual vaginal intercourse within four weeks before joining the study
You will not qualify if you...
- History of rectal surgery
- Suspected rectovaginal or retrocervical endometriosis
- History of brachytherapy or pelvic radiation
- Suspected malignancy
- History of severe pelvic inflammatory disease
- Active infection of the lower genital tract
- Pregnancy
- Not fluent in French or English
- Under legal guardianship or lacking judgment capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
Geneva University Hospital
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
E
Eloïse Krull
CONTACT
J
Jean Dubuisson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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