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NCT07749807
Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL
Conditions: Kidney Calculi, Nephrolithiasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Benha University
Location: Benha University Hospital Banhā Qalyubia Governorate
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07749807). StuddyBuddy aggregates publicly available trial information.