NCT05761275 Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
| NCT ID | NCT05761275 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jean Dubuisson |
| Condition | Gynecologic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2024-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Jean Dubuisson
PRINCIPAL INVESTIGATOR
University Hospital, Geneva
Frequently Asked Questions
Who can join the NCT05761275 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Gynecologic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05761275 currently recruiting?
Yes, NCT05761275 is actively recruiting participants. Contact the research team at eloise.krull@bluewin.ch for enrollment information.
Where is the NCT05761275 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT05761275 clinical trial?
NCT05761275 is sponsored by Jean Dubuisson. The principal investigator is Jean Dubuisson at University Hospital, Geneva. The trial plans to enroll 62 participants.