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临床试验/NCT06012864
NCT06012864尚未招募不适用

Modified Flank-free Supine Versus Prone PNL in Pediatric Renal Stones: A Prospective Randomized Comparative Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
sucess rate

研究概览

简要总结

To Compare the safety and efficacy of PNL in a modified flank-free supine position versus prone position in pediatric patients

详细描述

Incidence of pediatric urolithiasis varies from 5%-15% in developing countries to 1%-5% in the developed ones. The 5-year recurrence rate of about55% (range, 38%-70%). Fernstrom and Johansson first introduced percutaneous nephrolithotomy (PNL) in 1976. Since that PNL has become widely used for multiple indications. Pediatric PNL was done in the prone position with more rapid and easy puncture point determination, wider field for renal puncture, free application of multiple accesses, and avoidance of visceral injuries, especially the colon. PNL in the supine position has several advantages as, similar success rate and a shorter operative time than conventional PNL. The Amplatz sheath is oriented downward, maintaining a low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the fragmented stones. Furthermore, it's easier for the anesthesiologist to control the airway and reduce the neural and ophthalmologic pressure lesions than the prone position. Desoky et al in 2012 described the flank-free modified supine position (FFMSP) and claimed that this position overcomes the mechanical limitation of ordinary supine position because of ample space for puncture, dilatation, multiple tracts, and maneuverability of the system with the nephoscope. Moreover, the surgeon can comfortably sit during the operation, and X-ray exposure is reduced because puncture and dilatation are quite perpendicular to the body, and the operator's hands are outside the fluoroscopic field. it's better to do supine PNL in case of retro renal colon. as we see the supine position in pediatric is still under research and few trials about it had been done with no clear recommendation, so we will compare PNL in pediatric age group in modified free flank supine position versus prone position.

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
Single (Participant)

盲法说明

closed envelope

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≤ 18 years old. Renal stones are amenable for PNL with Guy's stone score 1-2.

排除标准

  • congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract infection. Patient refusing participation. Patients with PCN.

结局指标

主要结局

sucess rate

时间窗: within 3 months post operative

stone free rate

次要结局

  • complication rate(1 month)
  • operative time(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Kamel Abdel Rahman

DR

Assiut University

研究点 (2)

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