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临床试验/NCT05640219
NCT05640219尚未招募不适用

Benha Modification for Renal Track Creation in Percutaneous Nephrolithotomy (PCNL), How and Why?

Benha University0 个研究点目标入组 30 人开始时间: 2023年1月25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
30
主要终点
decrease the intraoperative complication

研究概览

简要总结

Benha modification for renal track creation in percutaneous nephrolithotomy (PCNL) Our modification aims to decrease the complications of PCNL in large stones

详细描述

Introduction : PCNL occupies the best stone management modality till now in large stones with promissing impacts as regard to morbidity and hospital stay time. (1,2,3) Many reported complications due to PCNL either intra or postoperative especially in large stones up to 83% including bleedng and extravasation .(4) Single step dilatation during PCNL track forminghave many advantages over sequential dilatation as it ismore economic with less blood loss and less radiation exposure, so it is advantageous than conventional Alken or teflon sequential dilators also it is more economic than balloon dilators. (5,6,7,8) To decrease the incidence bleeding, the manipulation should be limited and transpapillary puncture should be kept. (9) Extravasation remains one of the most serious complication during PCNL as vigorousabsorption of the irrigant fluid may cause electrolyte disbalance that may lead to cardiac complications (overload) or brain edema.. (10) Objective : Our modification aims to decrease the complications of PCNL in large stones.

Patients and methods : Our modification will be performed in our department in Benha univerisity hospital with a written consent on 10 patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/_ the upper calyx in patints 18 years old or more. Also, patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn stone will be excluded.

Preoperative assesment:

  • full history and clinical examination
  • full laboratory investigation including heamoglobin (Hb) and serum creatinine (Scr)
  • radiological investigation as pelviabdomenal ultrasound , plain X ray (KUB) and coputerized tomography (CT)

Intraoperative assesment:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/_ the upper calyx in patints 18 years old or more

排除标准

  • patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn

结局指标

主要结局

decrease the intraoperative complication

时间窗: intraoperative

assessing the operative time in minutes

blood loss in the operative theatre

时间窗: intraoperative

pre and postoperative haemoglobine in gram/dl

次要结局

  • early postoperative impact and incidence of complication(withen 10 days postoperative)

研究者

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

mohamed abdelrahman alhefnawy

assistant professor

Benha University

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