Evaluating women's sexual quality of life after minimally invasive surgery for benign ovarian conditions
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial
This study is testing if a new type of surgery for ovarian conditions affects women's sexual quality of life differently than traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University Hospital, Geneva Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Geneva) |
| Trial ID | NCT05761275 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of the vNOTES surgical technique on women's sexual quality of life following benign adnexal surgery. Women aged 18 to 70 requiring surgery for conditions such as ovarian cysts will be randomly assigned to receive either the vNOTES approach or conventional transabdominal laparoscopy. The study aims to demonstrate that vNOTES does not significantly affect sexual function compared to traditional methods, while also assessing efficiency, morbidity, and postoperative complications. This research addresses a gap in literature regarding women's concerns about sexual health post-surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 70 who require surgery for benign adnexal diseases and have engaged in heterosexual intercourse within the last four weeks.
Not a fit: Patients with a history of rectal surgery, suspected malignancy, or active lower genital tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance women's acceptance of the vNOTES technique, ensuring they can undergo surgery without fear of negatively impacting their sexual quality of life.
How similar studies have performed: While there are no prior randomized controlled trials specifically assessing sexual quality of life post-vNOTES for benign adnexal surgery, the approach has shown non-inferiority to conventional methods in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Geneva
- Geneva University Hospital — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jean Dubuisson — University Hospital, Geneva
- Study coordinator: Eloïse Krull
- Email: eloise.krull@bluewin.ch
- Phone: +41 (0)22 372 68 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.