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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorJean Dubuisson

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

62 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jean Dubuisson

Lead sponsor

University Hospital, Geneva

Sponsor institution