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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-04-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Elective cystectomy

Intervention Type PROCEDURE

Adnexal cyst removal for presumed benign adnexal pathology.

Elective oophorectomy

Intervention Type PROCEDURE

Ovarian removal for presumed benign adnexal pathology.

Elective salpingectomy

Intervention Type PROCEDURE

Tubal removal for presumed benign adnexal pathology.

Elective tubal sterilization

Intervention Type PROCEDURE

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).

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).

Group Type EXPERIMENTAL

Elective cystectomy

Intervention Type PROCEDURE

Adnexal cyst removal for presumed benign adnexal pathology.

Elective oophorectomy

Intervention Type PROCEDURE

Ovarian removal for presumed benign adnexal pathology.

Elective salpingectomy

Intervention Type PROCEDURE

Tubal removal for presumed benign adnexal pathology.

Elective tubal sterilization

Intervention Type PROCEDURE

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).

Interventions

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Elective cystectomy

Adnexal cyst removal for presumed benign adnexal pathology.

Intervention Type PROCEDURE

Elective oophorectomy

Ovarian removal for presumed benign adnexal pathology.

Intervention Type PROCEDURE

Elective salpingectomy

Tubal removal for presumed benign adnexal pathology.

Intervention Type PROCEDURE

Elective 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No