About this trial
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 criteria
Qualifiers
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
Disqualifiers
History of rectal surgery.
Suspected rectovaginal/retrocervical endometriosis.
History of brachytherapy or pelvic radiation.
Suspected malignancy.
Trial design
Treatments tested in this trial
- Elective cystectomy
- Elective oophorectomy
- Elective salpingectomy
- Elective tubal sterilization
Treatment groups
Sponsors and collaborators
Jean Dubuisson
Lead sponsor
University Hospital, Geneva
Sponsor institution