CompletedPhase 3

Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty

Egypt40 participantsStarted 2023-11-22

Plain-language summary

The main goals of this trial is to study the feasibility and safety of using barbed sutures compared to the conventional PGA (Polyglactin) sutures in minimally invasive dismembered pyeloplasty. The main questions in using barbed sutures would be: 1. Is it safe with similar post-operative outcomes? 2. Does it have any significant complications? 3. Is it easier to handle intra-operatively?

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

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: * Patients aged 18 to 60 undergoing robotic or laparoscopic dismembered pyeloplasty * History of dietls' crisis (Fever, pain) in a pelviureteric junction obstructed kidney * Decrease in glomerular filtration rate in a pelviureteric junction obstructed kidney Exclusion Criteria: * Contraindications for laparoscopy or robotic surgery as pulmonary obstructive or restrictive disease, and poor cardiovascular fitness * Uncontrolled diabetes mellitus * Morbid obesity * History of multiple major abdominal surgeries

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

Time difference for suture completion

Timeframe: 12 months (Intra-operative data)

Difference in complications rate

Timeframe: 18 months (Post-operative data)

Drain output post-operative

Timeframe: 12 months (Early post-operative data)

Trial details

NCT IDNCT06526559

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Pelvi-Ureteric Obstruction trials