Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Recruiting now · Not applicable
Conditions studied: Gynecologic Disease, Adnexal Mass, Adnexal Cyst, Sexuality, Adnexal Diseases, Sexual Dysfunction, Quality of Life, Pathology, Dyspareunia, Pelvic Pain, Complication
In brief
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.
Key facts
- Study ID
- NCT05761275
- Run by
- Jean Dubuisson
- People needed
- 62
- Starts
- 2024-01-01
- Expected to finish
- 2027-04-03
- Last updated by the study team
- 2025-03-27
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged from 18 to 70 years
- Discernment capacity with oral and written consent signed
- Heterosexual intercourse (with vaginal penetration) within four weeks prior to inclusion in the study
You may not qualify if…
- History of rectal surgery.
- Suspected rectovaginal/retrocervical endometriosis.
- History of brachytherapy or pelvic radiation.
- Suspected malignancy.
- History of severe pelvic inflammatory disease.
- Active lower genital tract infection.
- Pregnancy.
- Women who do not speak fluent French or English.
- Patients under tutelage (with or without capacity of judgement).
Where it is running
- Geneva University Hospital — Geneva, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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