Actively Recruiting
Assessment of Womens Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach Compared to Conventional Laparoscopy A Randomized Controlled Trial
Led by Jean Dubuisson · Updated on 2025-03-27
62
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of Transvaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES compared to conventional abdominal laparoscopy CAL for benign adnexal surgery in women aged 18 to 70. The study aims to confirm that vNOTES does not negatively affect womens sexual function after surgery, addressing concerns about vaginal scarring and its effects on sexual activity. Secondary goals include assessing vNOTES efficiency, complications, and the quality of histological analysis of surgical specimens. Participants will be randomly assigned to receive either the vNOTES or CAL surgical technique for procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization. Both approaches involve minimally invasive surgery, with vNOTES using the vaginal route and CAL using abdominal laparoscopy. The study also examines pain, hospital stay length, patient satisfaction, and surgical complications during and up to 30 days after surgery. Women in the study will complete questionnaires before surgery and at 3 and 6 months afterward to assess sexual function, couple satisfaction, and pain during sex. Medical and general data will be collected at enrollment, during hospitalization, and one month post-surgery. The main outcomes measured include quality of sexual life and postoperative recovery, while monitoring safety and the effectiveness of both surgical methods throughout the study period.
CONDITIONS
Brief Title
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged from 18 to 70 years
- Ability to understand and provide oral and written consent
- Had heterosexual intercourse with vaginal penetration within four weeks prior to inclusion
You will not qualify if you...
- History of rectal surgery
- Suspected rectovaginal or retrocervical endometriosis
- History of brachytherapy or pelvic radiation
- Suspected malignancy
- History of severe pelvic inflammatory disease
- Active lower genital tract infection
- Pregnancy
- Non-fluent in French or English
- Under legal tutelage or lacking capacity of judgement
Research Team
E
Eloïse Krull
J
Jean Dubuisson
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