Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL
Egypt100 participantsStarted 2026-09-01
Plain-language summary
This prospective randomized controlled study will compare two techniques used after percutaneous nephrolithotomy, a procedure for removing kidney stones. Participants with renal stones measuring 2-3 cm will be randomly assigned to either tubeless percutaneous nephrolithotomy with nebulized Glubran 2 used to seal the access tract or conventional percutaneous nephrolithotomy with placement of a nephrostomy tube. The study will evaluate whether the Glubran 2-assisted tubeless technique is safe and effective and whether it can reduce postoperative pain, bleeding, hospital stay, urine leakage, and other complications while maintaining a satisfactory stone-free rate.
Who can participate
Age range
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:
* Age 18 years or older.
* Single or multiple renal stones measuring 2-3 cm.
* Renal stones located in an anatomical position suitable for percutaneous nephrolithotomy.
* Participant considered suitable for PCNL under general anesthesia.
* Ability and willingness to provide written informed consent.
Exclusion Criteria:
* Active urinary tract infection.
* Renal stones in an anomalous kidney.
* Uncontrolled hypertension.
* Uncontrolled diabetes mellitus.
* Uncorrected coagulopathy.
* Clinically significant arrhythmia.
* Distal ureteric obstruction.
* Fixed hip joints preventing appropriate operative positioning.
* Previous renal surgery.
* Requirement for more than one percutaneous puncture.
* Pelvicalyceal system perforation during the procedure.
* Excessive intraoperative bleeding.
* Any intraoperative finding requiring nephrostomy tube placement for safety.
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
Postoperative Pain Intensity
Timeframe: Within the first 24 hours after surgery