vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic. (NCT05228938) | Clinical Trial Compass
TerminatedNot Applicable
vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.
Stopped: low enrollment rate
Israel1 participantsStarted 2022-05-29
Plain-language summary
Objective: To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization.
Study design: Prospective cohort, randomized controlled trial.
Study population: Planned Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.
Primary outcome - Adherence to planned surgical route, intra-operative parameters \& complications, post-operative parameters \& complications, rate of satisfaction.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women aged between 18 and 80 years.
. women who seek for definitive surgical sterilisation.
. women who planed for Elective bilateral salpingectomy or Salpingo-oophorectomy for a non-malignant indication
Exclusion criteria
. history of rectal surgery.
. rectovaginal endometriosis
. suspected malignancy
. History of pelvic inflammatory disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — can you tell me why it was stopped early, and what that means for what we know about the safety and effectiveness of the vNOTES approach for removing my fallopian tubes or ovaries?
2Since the main thing this study was measuring was whether the vNOTES procedure could be completed without having to switch to a different technique, how often does that kind of conversion happen in real practice, and what would it mean for me if it did?
3How does the vNOTES approach — which goes through the vagina — compare to standard laparoscopic surgery in terms of recovery time, pain, and scarring, given that this trial didn't fully complete its comparison?
4Because this trial was terminated, is there other evidence you'd rely on to feel confident recommending vNOTES over laparoscopy for my specific situation, or would laparoscopy be the safer, better-studied choice for me right now?
5Are there specific factors about my health or anatomy that would make one approach — vNOTES or laparoscopic — clearly more appropriate for me, especially given that we don't have full results from this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.