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临床试验/NCT03250559
NCT03250559Unknown不适用

Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study

Assiut University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
6
试验地点
1
主要终点
Stone free rate.

研究概览

简要总结

Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal stones since 1980. Although radiation exposure during PNL is within the safe limits for expert endourologist, the mutagenic hazard is still present especially in pediatric population. Therefore, employing an alternative imaging technique during PNL would be of added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided PNL was as effective as conventional one, this means that many children could be protected from the variable hazards of radiation exposure.

详细描述

The incidence of pediatric urolithiasis varies by geographic area. Most cases of pediatric urolithiasis are associated with anatomic or metabolic abnormalities or urinary tract infection . PNL can be performed safely and effectively in children by experienced surgeons, resulting in a high stone-free rate and lower requirement for ancillary treatment. In adults, PNL is performed under fluoroscopic or ultrasound guidance. In pediatric age group, fluoroscopic guidance was preferred in most of the reported studies. However, fluoroscopy exposes the patient to radiation. The International Commission on Radiological Protection recommends that whole body exposure in adults should be limited to an effective dose of 20 mSv per year over 5 years. In young children, it is particularly important to protect the developing gonads and thyroid gland, as the long-term effects of exposing these organs to radiation are still unclear. In contrast to fluoroscopic guidance, ultrasound guidance does not expose the patient to radiation, it also can provide real-time monitoring during the puncturing procedure. The path and depth of the needle, and the anatomy in and around the kidney, are clearly visible on ultrasound examination

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)

入排标准

年龄范围
6 Months 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All kidney stones in pediatric age group and indicated for PNL.

排除标准

  • Children unfit for the procedure or non indicated for it.
  • Parental refusal.

结局指标

主要结局

Stone free rate.

时间窗: Day one post operative.

Stone free rate (less than 4 mm residual is considered free).

次要结局

  • The need for blood transfusion.(within 24 hours of the procedure.)
  • Surrounding organ injury.(within first 24 hours post operative.)
  • Radiation exposure.(within one hour during the procedure.)

研究者

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

Ayman Asem Elqady

Principal investigator of urology-Assiut university

Assiut University

研究点 (1)

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