Comparing Womens Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES or Conventional Laparoscopy
Led by Jean Dubuisson · Updated on 2025-03-27
62
Participants Needed
1
Research Sites
39 weeks
Total Duration
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
Research Team
E
Eloïse Krull
J
Jean Dubuisson
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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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Assessment of women's sexual quality of life after benign adnexal surgery using vNOTES approach in comparison to conventional laparoscopy: protocol for a randomised controlled trial.