An interventional study of Tubeless Percutaneous Nephrolithotomy (PCNL) and Standard Tube Percutaneous Nephrolithotomy (PCNL) in Nephrolithiasis and Pediatric Nephrolithiasis, sponsored by Lady Reading Hospital, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Lady Reading Hospital, Pakistan · Not applicable, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
This study's enrollment of 640 is above the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Lady Reading Hospital, Pakistan is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Standard PCNL performed with placement of a nephrostomy tube following stone clearance, along with a double-J stent.
Procedure: Standard Tube 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.
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.
Length of hospital stay (days)
Number of days from the date of surgery until discharge from hospital.
Time frame: 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.
Time frame: During surgery (single procedure).
Blood transfusion requirement (%)
Proportion of participants requiring perioperative blood transfusion, as documented in patient records.
Time frame: 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).
Time frame: At hospital discharge (within 48 hours after surgery).
Postoperative pain score (Visual Analog Scale)
Pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse pain. The score will be averaged over the first 24 hours after surgery.
Time frame: First 24 hours post-surgery
Analgesic requirement (morphine equivalents, mg)
Total opioid dose used postoperatively in the first 48 hours, converted to morphine equivalents and measured in milligrams.
Time frame: First 48 hours post-surgery
Postoperative complications (Clavien-Dindo classification)
Number and severity of complications graded using the Clavien-Dindo classification system.
Time frame: surgery to discharge (up to 7 days)
Time to return to normal activity (days)
Number of days from surgery until the patient resumes routine daily activities, as reported by patient/parent.
Time frame: Up to 30 days post-surgery
Patient and family satisfaction score
Satisfaction with overall care and outcome, measured using a 10-point Likert scale questionnaire completed at discharge.
Time frame: At hospital discharge (within 7 days post-surgery)
Plan to share: Undecided — Data sharing plans have not been finalized. This will depend on journal requirements, funding agency policies, and institutional guidelines at the time of publication.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Lady Reading Hospital, Pakistan