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临床试验/CTRI/2020/07/026933
CTRI/2020/07/026933尚未招募1 期

ASSESSMENT OF EFFICACY, SAFETY AND POSTOPERATIVE OUTCOME OF STANDARD PERCUTANEOUS NEPHROLITHOTOMY VERSUS TUBELESS PERCUTANEOUS NEPHROLITHOTOMY IN CASES OF NEPHROLITHIASIS:A RANDOMIZED CONTROLLED TRIAL

SSSIHMS Puttaparthi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月8日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare postoperative pain and analgesia requirement

研究概览

简要总结

Present study is a single institute, prospective study, with intention to compare and evaluate the effectiveness and safety of standard percutaneous nephrolithomy (PCNL) versus tubeless PCNL in the Department of Urology, Sri Sathya Sai Institute of Higher Medical Sciences – Prasanthigram, Anantapur, Andhra Pradesh. A minimum of 100 cases of renal stone disease that are willing to undergo PCNL will be included after taking written informed consent. Patients will be divided randomly into two groups involving minimum of 50 patients in each group. Group A patients will undergo Tubeless PCNL procedure and Group B patients will undergo Standard PCNL. The routine evaluation of patients enrolled in the study will be done as per the structured proforma. The efficacy and safety of the operative procedure will be analyzed based on postoperative pain score, analgesia requirement, fall in haemoglobin, blood transfusion requirement, duration of hematuria, duration of urine leak, duration of hospital stay and any other postoperative complications.The purpose of this study is to objectively compare the standard and tubeless PCNL depending on different variables and at the end of the study to provide guidance regarding preference of choice among the two methods in cases of nephrolithiasis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Stone size more than 2 cm (any Guy’s stone score grade) 2.Single percutaneous tract 3.Complete stone clearance as assessed by intraoperative nephroscopy and fluoroscopy.

排除标准

  • 1.​Age less than 18 years and more than 50 years 2.​Residual calculi 3.​Significant bleeding at the end of procedure 4.​More than one percutaneous tract 5.​Preoperative deranged renal function tests 6.​History of previous surgery on ipsilateral urinary tract.

结局指标

主要结局

To compare postoperative pain and analgesia requirement

时间窗: Every 6 hours after surgery upto period of discharge

次要结局

  • To compare(Operative time)

研究者

发起方
SSSIHMS Puttaparthi
申办方类型
Private hospital/clinic

研究点 (1)

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