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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07749807). StuddyBuddy aggregates publicly available trial information.