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

NCT07183930 | Completed

• 1 other identifier: KMC-IREB-533
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blood transfusion; Kidney stone surgery; Tubeless PCNL; PCNL; Percutaneous nephrolithotomy; Stone-free rate

Outcome Measures

Primary Outcomes (4)

• Length of hospital stay (days)

  Number of days from the date of surgery until discharge from hospital.

  From surgery to discharge (up to 7 days).

• Operative time (minutes)

  Duration of the surgical procedure measured from skin incision to skin closure, recorded in minutes.

  During surgery (single procedure).

• Blood transfusion requirement (%)

  Proportion of participants requiring perioperative blood transfusion, as documented in patient records.

  surgery through hospital discharge (up to 7 days).

• Stone-free status (%)

  Proportion of patients with no residual stone fragments \>2 mm on postoperative imaging (ultrasound or CT).

  At hospital discharge (within 48 hours after surgery).

Secondary Outcomes (5)

• Postoperative pain score (VAS)

  First 24 hours post-surgery

• Analgesic requirement (morphine equivalents, mg)

  First 48 hours post-surgery

• Postoperative complications (Clavien-Dindo classification)

  surgery to discharge (up to 7 days)

• Time to return to normal activity (days)

  Up to 30 days post-surgery

• Patient and family satisfaction score

  At hospital discharge (within 7 days post-surgery)

Study Arms (2)

Tubeless PCNL

EXPERIMENTAL

Percutaneous nephrolithotomy (PCNL) performed without nephrostomy tube placement. After complete stone clearance and confirmation of hemostasis, only a double-J stent is placed; the access tract is left to seal naturally.

Procedure: Tubeless Percutaneous Nephrolithotomy (PCNL)

Tube PCNL

ACTIVE COMPARATOR

Standard PCNL performed with placement of a nephrostomy tube following stone clearance, along with a double-J stent.

Procedure: Standard Tube Percutaneous Nephrolithotomy (PCNL)

Interventions

Tubeless Percutaneous Nephrolithotomy (PCNL) PROCEDURE

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.

Tubeless PCNL

Standard Tube Percutaneous Nephrolithotomy (PCNL) PROCEDURE

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.

Tube PCNL

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lady Reading Hospital, Pakistan: lead
• Khyber Teaching Hospital: collaborator

Study Sites (1)

Khyber Teaching Hospital, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tariq Ahmad, MBBS, FCPS

  Khyber Teaching Hospital, Peshawar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tariq

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2024
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

PA (1)