The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Tra… (NCT07465822) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital
Turkey (Türkiye)19 participantsStarted 2025-04-18
Plain-language summary
This prospective observational study aims to evaluate the learning curve of obstetrics and gynecology residents performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) hysterectomy in a university hospital setting. V-NOTES hysterectomy is a minimally invasive surgical technique performed through the vaginal route that combines the advantages of laparoscopy without requiring abdominal incisions. The study will assess the progression of surgical performance of a resident performing V-NOTES hysterectomy under the supervision of an experienced attending surgeon. Key operative and postoperative outcomes will be recorded to evaluate the acquisition of surgical proficiency over time.
Who can participate
Age range
18 Years – 70 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:
* Voluntary participation in the study and provision of written informed consent
* Female patients aged between 18 and 70 years
* Patients admitted to the Department of Obstetrics and Gynecology at Çukurova -University and scheduled for elective hysterectomy
* Patients deemed suitable for V-NOTES hysterectomy based on preoperative evaluation
Exclusion Criteria:
* Refusal to provide informed consent
* Anatomical or technical limitations preventing placement in the lithotomy -position
* Pregnancy
* Presence of acute abdomen or indication for emergency surgery
* Presence or history of deep infiltrating endometriosis
* Suspected pelvic adhesions
* Detection of a nodule in the pouch of Douglas
* Fixed uterus on pelvic examination
* Sexually inactive patients
* History of tubo-ovarian abscess
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
Operative time of V-NOTES hysterectomy
Timeframe: Baseline (pre-procedure), perioperative/periprocedural period