Vaginal Natural Orifice Trans-luminal Endoscopic Surgery Salpingectomy for Tubal Sterilization: C… (NCT05581654) | Clinical Trial Compass
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Vaginal Natural Orifice Trans-luminal Endoscopic Surgery Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis
Belgium240 participantsStarted 2022-09-12
Plain-language summary
The evolution from classical open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality.
Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) have moved forward the practice in "Minimally Invasive Surgery".
Recently, clinical application of vNOTES has broadened significantly in the field of gynaecological surgery.
As the application of vNOTES is increasing, it is deemed mandatory to assess the clinical outcomes and the learning curve (LC) of this novel technique.
There is a paucity of reports in the literature analysing prospectively the clinical outcomes the LC of vNOTES in the gynaecological field.
To the investigator's knowledge, there is no published prospective multicentre study that aims to evaluate the peri- and postoperative outcomes and the LC of salpingectomy for tubal sterilization by the technique of vNOTES.
Who can participate
Age range
18 Years – 50 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:
* 18 - 50 years
* Non-prolapsed uterus
* Asking for tubal sterilisation
* Any parity
* Written informed consent
Exclusion Criteria:
* History of pelvic inflammatory disease.
* Recto-vaginal endometriosis.
* Suspicion of genital tract malignancy.
* Active lower genital tract infection.
* History of rectal surgery.
* Stage III or IV Uterine prolapse (defined by the International Continence Society classification).
* Complete obliteration of the posterior douglas pouch determined by pelvic examination.
* Virginity.
* Failure to provide written informed consent.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Proportion of women successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure.