Status:
RECRUITING
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Lead Sponsor:
Jean Dubuisson
Conditions:
Gynecologic Disease
Adnexal Mass
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 laparo...
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 ...
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).
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 3 2027
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05761275
Start Date
January 1 2024
End Date
April 3 2027
Last Update
March 27 2025
Active Locations (1)
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1
Geneva University Hospital
Geneva, Switzerland, 1205