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Tubeless vs Tube PCNL in Pediatric Nephrolithiasis: A Randomized Controlled Trial.

NCT07183930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Nephrolithiasis
  • Kidney Stones
  • Pediatric Nephrolithiasis

Interventions

PROCEDURE

Tubeless Percutaneous Nephrolithotomy (PCNL)

Mini-PCNL with tract dilation up to 18 Fr and stone fragmentation by pneumatic lithotripsy. Following clearance, a double-J stent is placed; no nephrostomy tube is inserted.

PROCEDURE

Standard Tube Percutaneous Nephrolithotomy (PCNL)

Mini-PCNL with tract dilation up to 18 Fr and stone fragmentation by pneumatic lithotripsy. Following clearance, a 14 Fr nephrostomy tube and a double-J stent are placed.

Sponsors & Collaborators

  • Khyber Teaching Hospital

    collaborator OTHER

  • Lady Reading Hospital, Pakistan

    lead OTHER_GOV

Principal Investigators

  • Tariq Ahmad, MBBS, FCPS · Khyber Teaching Hospital, Peshawar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-09-10
Completion
2025-09-10

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07183930 on ClinicalTrials.gov