Actively Recruiting
Led by Jean Dubuisson · Updated on 2025-03-27
62
Participants Needed
1
Research Sites
39 weeks
Total Duration
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 women's 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
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus hospital stay up to 30 days after surgery
Participants undergo surgery for benign adnexal disease using either the vNOTES or conventional laparoscopy surgical technique as assigned. This includes procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization.
Hospitalization day of surgery and follow-up visits up to 30 days post-surgery
Duration - 6 months
Participants complete questionnaires assessing sexual quality of life and pain before surgery and at 3 and 6 months after surgery. Medical data and complications are monitored up to one month after surgery.
3 visits at pre-surgery, 3 months, and 6 months post-surgery
Total: 1 location
1
Geneva University Hospital
Geneva, Switzerland, 1205
Actively Recruiting
E
Eloïse Krull
J
Jean Dubuisson
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Eloïse Krull, Shahzia Lambat Emery, Manuela Viviano...
https://pubmed.ncbi.nlm.nih.gov/37678943