Comparison Between Tubeless and Tube Percutaneous Nephrolithotomy in Pediatric Population: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Length of hospital stay (days)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Tube PCNL
Standard PCNL performed with placement of a nephrostomy tube following stone clearance, along with a double-J stent.
干预措施: Standard Tube Percutaneous Nephrolithotomy (PCNL) (Procedure)
结局指标
主要结局
Length of hospital stay (days)
时间窗: From surgery to discharge (up to 7 days).
Number of days from the date of surgery until discharge from hospital.
Operative time (minutes)
时间窗: During surgery (single procedure).
Duration of the surgical procedure measured from skin incision to skin closure, recorded in minutes.
Blood transfusion requirement (%)
时间窗: surgery through hospital discharge (up to 7 days).
Proportion of participants requiring perioperative blood transfusion, as documented in patient records.
Stone-free status (%)
时间窗: At hospital discharge (within 48 hours after surgery).
Proportion of patients with no residual stone fragments \>2 mm on postoperative imaging (ultrasound or CT).
次要结局
- Postoperative pain score (Visual Analog Scale)(First 24 hours post-surgery)
- 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))
研究者
Dr. Waseem Ullah
Assistant Professor
Khyber Teaching Hospital