NCT05761275

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2024Apr 2027

First Submitted

Initial submission to the registry

January 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2027

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

January 10, 2023

Last Update Submit

March 24, 2025

Conditions

Gynecologic DiseaseAdnexal MassAdnexal CystSexualityAdnexal DiseasesSexual DysfunctionQuality of LifePathologyDyspareuniaPelvic PainComplication

Outcome Measures

Primary Outcomes (9)

  • Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.

    Preoperative

  • Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.

    3 months postoperative

  • Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.

    6 months postoperative

  • Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire. CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.

    Preoperative

  • Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire. CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.

    3 months postoperative

  • Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire. CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.

    6 months postoperative

  • Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia. This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.

    Preoperative

  • Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia. This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.

    3 months postoperative

  • Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia

    Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia. This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.

    6 months postoperative

Secondary Outcomes (8)

  • Effectiveness

    Peroperative

  • Pain evaluation

    Preoperative

  • Lenght of stay

    During hospital stay, from day of the surgery up to 30 days after surgery

  • Pain evaluation

    During hospital stay, from day of the surgery up to 30 days after surgery

  • Pain evaluation

    1 month postoperative

  • +3 more secondary outcomes

Study Arms (2)

Conventional Abdominal Laparoscopy

ACTIVE COMPARATOR

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).

Procedure: Elective cystectomyProcedure: Elective oophorectomyProcedure: Elective salpingectomyProcedure: Elective tubal sterilization

vNOTES

EXPERIMENTAL

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).

Procedure: Elective cystectomyProcedure: Elective oophorectomyProcedure: Elective salpingectomyProcedure: Elective tubal sterilization

Interventions

Elective cystectomyPROCEDURE

Adnexal cyst removal for presumed benign adnexal pathology.

Conventional Abdominal LaparoscopyvNOTES
Elective oophorectomyPROCEDURE

Ovarian removal for presumed benign adnexal pathology.

Conventional Abdominal LaparoscopyvNOTES
Elective salpingectomyPROCEDURE

Tubal removal for presumed benign adnexal pathology.

Conventional Abdominal LaparoscopyvNOTES
Elective tubal sterilizationPROCEDURE

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).

Conventional Abdominal LaparoscopyvNOTES

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged from 18 to 70 years
  • Discernment capacity with oral and written consent signed

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

  • Krull E, Lambat Emery S, Viviano M, Aerts L, Petignat P, Dubuisson J. Assessment of women's sexual quality of life after benign adnexal surgery using vNOTES approach in comparison to conventional laparoscopy: protocol for a randomised controlled trial. BMJ Open. 2023 Sep 7;13(9):e073691. doi: 10.1136/bmjopen-2023-073691.

    PMID: 37678943DERIVED

MeSH Terms

Conditions

Genital Diseases, FemaleSexualityAdnexal DiseasesSexual Dysfunction, PhysiologicalDyspareuniaPelvic Pain

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexual BehaviorBehaviorGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Dubuisson

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eloïse Krull

CONTACT

+41 (0)22 372 68 16eloise.krull@bluewin.ch

Jean Dubuisson

CONTACT

Jean.Dubuisson@hcuge.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2023

First Posted

March 9, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

April 3, 2027

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)