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临床试验/NCT05593783
NCT05593783招募中不适用

The Use of the "Comprehensive Complication Index" as a Recording System of Postoperative Complications After Percutaneous, Retrograde and Extracorporeal Lithotripsy for Renal Lithiasis.

Sismanoglio General Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
comprehensive complication index score

研究概览

简要总结

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Data regarding post operative descriptions will be recorded and comprehensive complication index will be used for the assesment of the burden.

详细描述

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. The study will take place at the 2nd Urology Clinic of the University of Athens, at the Sismanoglio Hospital of Athens. It will include patients diagnosed with kidney stones after plain X-ray and/or CT scan. Percutaneous nephrolithotripsy will be performed on stones > 2 cm, while extracorporeal or retrograde nephrolithotripsy on stones < 2 cm. Patient demographics (age, gender, body mass index, comorbidities, anticoagulant use), stone-related data (maximum stone size, anatomic location of stone, number of stones, presence of hydronephrosis preoperatively, presence of piglet catheter preoperatively, positive urine culture, preoperative chemoprophylaxis ) as well as information about the operation (type of anesthesia, operation time, hospitalization time) will be reported. Finally, all possible complications will be recorded intraoperatively, immediately postoperatively and up to 30 days after the day of surgery. This will be followed by a statistical analysis of the resulting data and a comparison between the CDC and CCI systems using the SPSS statistical program. To describe continuous variables, the mean/standard deviation will be used if it is a normal distribution, or the median and range if it is a non-normal distribution. The Shapiro-Wilk test will be used to investigate the distribution of the data. The absolute number and the corresponding percentage will be used to describe the qualitative variables. For the comparison of continuous variables, the parametric t-test will be used if the data follow a normal distribution, or the Mann-Whitney U test if they do not follow a normal distribution. Chi-square and Fisher's exact test will be used to compare qualitative variables. Exclusion criteria from this study are:

  1. Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
  2. Recent similar operation that the patient has undergone (interval of less than one month).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with urinary lithiasis undergoing ureterolithotripsy, percutaneous nephrolithotripsy or extracorporeal shockwave lithotripsy.

排除标准

  • Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
  • Recent similar operation that the patient has undergone (interval of less than one month).

结局指标

主要结局

comprehensive complication index score

时间窗: 1,5 year

reporting postoperative complications with clavien dindo and comprehensive complication index and comparison of those two.

次要结局

未报告次要终点

研究者

发起方
Sismanoglio General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stamatios Katsimperis

Dr Stamatios Katsimperis

Sismanoglio General Hospital

研究点 (1)

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