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| Name | Class |
|---|---|
| Khyber Teaching Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Tube PCNL | Active Comparator | Standard PCNL performed with placement of a nephrostomy tube following stone clearance, along with a double-J stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score (VAS) | Pain intensity assessed using the Visual Analog Scale (0-10), averaged over the first 24 hours after surgery. | First 24 hours post-surgery |
| Analgesic requirement (morphine equivalents, mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tariq Ahmad, MBBS, FCPS | Khyber Teaching Hospital, Peshawar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khyber Teaching Hospital, Peshawar | Peshawar | Khyber Pakhtunkhwa | 25000 | Pakistan |
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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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. |
|
Total opioid dose used postoperatively in the first 48 hours, converted to morphine equivalents and measured in milligrams.
| First 48 hours post-surgery |
| Postoperative complications (Clavien-Dindo classification) | Number and severity of complications graded using the Clavien-Dindo classification system. | 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. | 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. | At hospital discharge (within 7 days post-surgery) |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |