CompletedNot Applicable

Unilateral Versus Bilateral High Uterosacral Ligament Suspension Following vNOTES Hysterectomy for Apical Pelvic Organ Prolapse: A Prospective Study

Turkey (Türkiye)160 participantsStarted 2023-01-01

Plain-language summary

This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. The objective is to evaluate the effectiveness and safety of both surgical approaches in terms of anatomical outcomes and postoperative complications. The results of this study may help guide surgical decision-making in the management of pelvic organ prolapse.

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: * Female patients aged 18 years and older * Diagnosis of pelvic organ prolapse requiring surgical treatment * Planned vaginal hysterectomy with high uterosacral ligament suspension * Ability to provide informed consent Exclusion Criteria: * Previous pelvic organ prolapse surgery involving apical support * Presence of pelvic malignancy * Active pelvic infection * Severe comorbidities contraindicating surgery * Pregnancy

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

Anatomical Success Rate

Timeframe: 12 months postoperatively

Trial details

NCT IDNCT07552337

SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials