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Completed NCT07183930

Tubeless vs Tube PCNL in Pediatric Nephrolithiasis

Conditions: Nephrolithiasis, Pediatric Nephrolithiasis

Sex: All
Ages: 6 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 640
Sponsor: Lady Reading Hospital, Pakistan

Location: Khyber Teaching Hospital, Peshawar Peshawar Khyber Pakhtunkhwa

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.

Eligibility Criteria

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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07183930). StuddyBuddy aggregates publicly available trial information.