Comparison of the Outcome of Mini-Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Operative Time
研究概览
简要总结
Renal stone disease is a common urological condition associated with significant morbidity. Percutaneous nephrolithotomy (PCNL) is the standard treatment for renal stones larger than 2 cm. Although standard PCNL (Percutaneous nephrolithotomy) is associated with high stone-free rates, it carries a risk of complications such as bleeding and prolonged hospital stay. Mini percutaneous nephrolithotomy has been introduced as a less invasive alternative with the potential to reduce morbidity. However, evidence comparing outcomes between mini-PCNL (Percutaneous nephrolithotomy) and standard PCNL (Percutaneous nephrolithotomy) remains inconsistent, particularly in the local population. This randomized controlled trial aims to compare operative and postoperative outcomes of mini-PCNL versus standard PCNL in patients with renal stones.
详细描述
Percutaneous nephrolithotomy is the preferred surgical intervention for large renal calculi. Despite its effectiveness, standard PCNL is associated with complications including hemorrhage, postoperative pain, and prolonged hospitalization. Mini-PCNL utilizes a smaller tract size, potentially reducing parenchymal injury and blood loss while maintaining adequate stone clearance. Previous studies have reported conflicting results regarding operative time, stone-free rates, and complications between the two techniques. Additionally, limited data are available from Pakistan. This randomized controlled trial will compare operative time, hemoglobin drop, stone clearance, postoperative fever, and length of hospital stay between mini-PCNL and standard PCNL, with the aim of identifying the safer and more effective approach for renal stone management.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Inclusion Criteria:
- •Patients aged 20 to 60 years
- •Both male and female participants
- •Single renal pelvic stone less than 30 mm in size
- •Diagnosis confirmed by intravenous urography and ultrasonography
排除标准
- •Coagulopathy (INR > 1.5)
- •Active urinary tract infection
- •Staghorn calculus
- •Renal structural anomalies
- •Polycystic kidney disease
- •Ectopic or transplanted kidney
- •Renal malignancy
- •Uncontrolled pyonephrosis
- •Chronic renal failure or chronic liver disease
研究组 & 干预措施
Mini Percutaneous Nephrolithotomy
Patients will undergo Mini Percutaneous Nephrolithotomy using an 11-13 Fr Amplatz sheath and Semi-rigid Ureteroscope for stone fragmentation and removal.
干预措施: Mini Percutaneous Nephrolithotomy (Procedure)
Standard Percutaneous Nephrolithotomy
Patients will undergo Standard Percutaneous Nephrolithotomy using a 30 Fr Amplatz sheath and Standard Nephroscope.
干预措施: Standard Percutaneous Nephrolithotomy (Procedure)
结局指标
主要结局
Operative Time
时间窗: From renal puncture to skin closure during the index surgical procedure
Duration of operative time measured in minutes from renal puncture to skin closure.
Stone Clearance Rate
时间窗: Assessed at 1 week post-procedure.
Absence of residual stones on X-ray KUB ( Kidney, Ureter, Bladder) or ultrasonography at the time of discharge.
次要结局
- Hemoglobin Drop(Preoperqtively and 24 hours post-procedure.)
- Postoperative Fever(Post procedure up to 24 hours.)
- Length of Hospital Stay(through hospital discharge, an average of 3 days)
研究者
Dr Murad Ali
Resident Urologist, Department of Urology
Khyber Teaching Hospital