Clinical trial NCT05761275: Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Official title: Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Disease
Adnexal Mass
Adnexal Cyst
Sexuality
Adnexal Diseases
Sexual Dysfunction
Quality of Life
Pathology
Dyspareunia
Pelvic Pain
Complication
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study focuses on women aged 18 to 70 who require surgery for benign adnexal disease (removal of an ovarian cyst, ovary and/or fallopian tube). This is a randomised study, i.e. each woman will be randomly assigned the surgical technique used for the planned operation, either vNOTES or conventional transabdominal laparoscopy.

Currently, there are no randomised clinical trials specifically investigating the impact on women's sexual quality of life after benign adnexal surgery compared to conventional transabdominal laparoscopy. Patients appear to be more reticent about the vaginal approach to surgery due to fear of possible alteration of their sexual activity afterwards. Indeed, their fears relate to the vaginal scarring that occurs during the vNOTES surgery. The vaginal scar could cause vaginal pain and pain during sexual intercourse, especially if there is a post-operative complication with the vaginal scar. The vaginal scar could also alter women's perception of their bodies during sexual intercourse. This study is necessary to answer these questions and increase women's acceptance of the vNOTES technique for benign adnexal surgery. In this way, women would benefit from the advantages of vNOTES without fearing an impact on their sexual quality of life.

The primary objective of this study is to demonstrate that the vNOTES technique, although using the vagina as an entry route, does not significantly alter the quality of sexual life of women after benign adnexal surgery compared to conventional transabdominal laparoscopy.

The secondary objectives of this study evaluate the effectiveness of vNOTES (impact on pain, length of stay after surgery and patient satisfaction), complications ( during surgery and up to 30 days after surgery), as well as the relationship between the need to cut the surgical specimen for extraction and the difficulty of microscopic analysis.

All participants in the study, regardless of the surgical technique assigned to them, will complete questionnaires to assess their quality of sexual life before surgery and at 3 and 6 months after surgery. These are the FSFI (female sexual function), CSI-16 (couple satisfaction) and a self-created questionnaire on pain during sex (dyspareunia). These questionnaires will determine whether there is a difference in the women's quality of sexual life before and after surgery, as well as comparing the two surgical techniques. The participants' general and medical data will be collected at the time of study enrolment, during hospitalisation and at one month after surgery to assess the secondary objectives of the study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
timeFrame: Preoperative
measure: Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
timeFrame: 3 months postoperative
measure: Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
timeFrame: 6 months postoperative
measure: Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
timeFrame: Preoperative
measure: Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
timeFrame: 3 months postoperative
measure: Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
timeFrame: 6 months postoperative
measure: Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
timeFrame: Preoperative
measure: Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
timeFrame: 3 months postoperative
measure: Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Effectiveness
timeFrame: Peroperative
measure: Pain evaluation
timeFrame: Preoperative
measure: Lenght of stay
timeFrame: During hospital stay, from day of the surgery up to 30 days after surgery
measure: Pain evaluation
timeFrame: During hospital stay, from day of the surgery up to 30 days after surgery
measure: Pain evaluation
timeFrame: 1 month postoperative
measure: Complications rate
timeFrame: Peroperative
measure: Complications rate
timeFrame: 1 month postoperative
measure: Histological analysis after morcellation/aspiration of the surgical specimen
timeFrame: Peroperative
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Jean Dubuisson
role: PRINCIPAL_INVESTIGATOR
References: