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NCT Number: NCT07183930

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

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.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber Teaching Hospital, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

Pediatric kidney stones are increasingly common and often require surgical management when stones are larger than 10 mm or fail to pass with conservative treatment. Percutaneous nephrolithotomy (PCNL) is the gold standard for such cases. Traditionally, PCNL involves the placement of a nephrostomy tube to ensure postoperative drainage. However, this tube can increase discomfort, lengthen hospital stay, and sometimes lead to bleeding.

Recent advances in adult populations suggest that "tubeless" PCNL-where no external drainage tube is left-may reduce postoperative pain, decrease hospital stay, and improve recovery, without compromising safety. Evidence in children remains limited, mostly from small retrospective series.

This randomized controlled trial was conducted at Khyber Teaching Hospital, Peshawar, between October 2024 and March 2025. A total of 640 pediatric patients aged 6-18 years with renal stones >10 mm were randomized into two groups: Group A (Tubeless PCNL, n=320) and Group B (Tube PCNL, n=320). All procedures were performed by a single experienced pediatric urologist using standardized mini-PCNL techniques.

The primary outcomes include operative time, hospital stay, blood transfusion requirement, and stone-free status on discharge. Secondary outcomes include postoperative pain scores, analgesic use, complications (graded by Clavien-Dindo classification), time to resumption of normal activities, and patient/family satisfaction.

By directly comparing the two approaches in a large pediatric cohort, this study provides high-quality evidence to determine whether tubeless PCNL should be considered the preferred technique in appropriately selected children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Length of hospital stay (days)

    Time frame: From surgery to discharge (up to 7 days).

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

  2. Operative time (minutes)

    Time frame: During surgery (single procedure).

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

  3. Blood transfusion requirement (%)

    Time frame: surgery through hospital discharge (up to 7 days).

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

  4. Stone-free status (%)

    Time frame: At hospital discharge (within 48 hours after surgery).

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

Secondary outcomes

  1. Postoperative pain score (VAS)

    Time frame: First 24 hours post-surgery

    Pain intensity assessed using the Visual Analog Scale (0-10), averaged over the first 24 hours after surgery.

  2. Analgesic requirement (morphine equivalents, mg)

    Time frame: First 48 hours post-surgery

    Total opioid dose used postoperatively in the first 48 hours, converted to morphine equivalents and measured in milligrams.

  3. Postoperative complications (Clavien-Dindo classification)

    Time frame: surgery to discharge (up to 7 days)

    Number and severity of complications graded using the Clavien-Dindo classification system.

  4. Time to return to normal activity (days)

    Time frame: Up to 30 days post-surgery

    Number of days from surgery until the patient resumes routine daily activities, as reported by patient/parent.

  5. Patient and family satisfaction score

    Time frame: At hospital discharge (within 7 days post-surgery)

    Satisfaction with overall care and outcome, measured using a 10-point Likert scale questionnaire completed at discharge.

Sponsors and collaborators

Lead sponsor

Lady Reading Hospital, Pakistan

Other Gov

Collaborators

  • Khyber Teaching Hospital

Registry information

Official study title

Comparison Between Tubeless and Tube Percutaneous Nephrolithotomy in Pediatric Population: A Randomized Controlled Trial

Acronym: TUBELESS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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