RecruitingNot ApplicableNCT05761275

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

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

Sponsor

Jean Dubuisson

Enrollment

62 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Quality of Life Sexual Dysfunction Pathology Complication Sexuality Adnexal Cyst Adnexal Mass Gynecologic Disease Dyspareunia Pelvic Pain Adnexal Diseases

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria9

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).

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Interventions

PROCEDUREElective cystectomy

Adnexal cyst removal for presumed benign adnexal pathology.

PROCEDUREElective oophorectomy

Ovarian removal for presumed benign adnexal pathology.

PROCEDUREElective salpingectomy

Tubal removal for presumed benign adnexal pathology.

PROCEDUREElective tubal sterilization

Tubal obstruction as a definitive contraceptive method (tubal cauterization with or without sectioning, partial or total removal of both tubes, or obstruction with small clips/ligatures).