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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Geneva University Hospital
RECRUITING
Geneva
Contact Information
Primary
Eloïse Krull
eloise.krull@bluewin.ch
+41 (0)22 372 68 16
Backup
Jean Dubuisson
Jean.Dubuisson@hcuge.ch
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-04-03
Participants
Target number of participants: 62
Treatments
Active_comparator: Conventional Abdominal Laparoscopy
Use of conventional transabdominal laparoscopy as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization).
Experimental: vNOTES
Use of vNOTES (Transvaginal Natural Orifice Transluminal Endoscopic Surgery) as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization).
Sponsors
Leads: Jean Dubuisson

This content was sourced from clinicaltrials.gov