Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterov… (NCT02877407) | Clinical Trial Compass
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Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
South Korea146 participantsStarted 2016-06
Plain-language summary
* objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse
* prospective randomized clinical trial
* patient
1. 60yrs or more women and
2. POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
* number of patient: 146
* randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy
* follow up: postoperative 1 year
* primary endpoint: recurrence rate
1. recurrence of uterovaginal prolapse POP-Q stage II-IV
2. recurrence of associated symptom
* secondary endpoint
1. postoperative 1 year QOL, degree of satisfaction evaluation
2. operative time, estimated blood loss
3. hospitalization period, postoperative pain, return to normal activity
Who can participate
Age range
60 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:
* POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
Exclusion Criteria:
* abnormal uterine bleeding
* significantly enlarged fibroid uterus
* postmenopausal uterine bleeding
* endometrial pathology
* on tamexifen
* concomitant medical problems precluding general anesthesia or surgery
* damaged agreement ability
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.