Tubeless vs Tube PCNL in Pediatric Nephrolithiasis: A Randomized Controlled Trial. (NCT07183930) | Clinical Trial Compass
CompletedNot Applicable
Tubeless vs Tube PCNL in Pediatric Nephrolithiasis: A Randomized Controlled Trial.
Pakistan640 participantsStarted 2024-10-01
Plain-language summary
This study is designed to compare two surgical techniques for removing kidney stones in children and adolescents (ages 6-18 years). Both methods are types of percutaneous nephrolithotomy (PCNL), a standard procedure for kidney stones larger than 10 mm.
In the traditional method, a temporary tube (nephrostomy tube) is left in the kidney after surgery to drain urine. In the newer "tubeless" method, the tube is not used, and only a small internal stent may be placed. We want to find out if the tubeless method is as safe and effective as the traditional method, and whether it reduces pain, hospital stay, and the need for blood transfusions. The study involves 640 patients at Khyber Teaching Hospital in Peshawar, Pakistan. Each participant is randomly assigned to one of the two techniques.
Who can participate
Age range
6 Years – 18 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:
* Children aged 6 to 18 years
* Either gender
* Renal calculi larger than 10 mm on imaging
* Failed conservative management or extracorporeal shock wave lithotripsy (ESWL)
* Normal renal function
* Informed consent from parents/guardians
* Assent from children aged 12 years and above
Exclusion Criteria:
* Prior renal surgery or ureteral stenting
* Congenital urological anomalies
* Active urinary tract infection at the time of surgery
* Known bleeding disorders or use of anticoagulant medication
* Significant comorbid medical conditions
* Pregnancy (in adolescent females)
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
Length of hospital stay (days)
Timeframe: From surgery to discharge (up to 7 days).
2
Operative time (minutes)
Timeframe: During surgery (single procedure).
3
Blood transfusion requirement (%)
Timeframe: surgery through hospital discharge (up to 7 days).
4
Stone-free status (%)
Timeframe: At hospital discharge (within 48 hours after surgery).