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临床试验/NCT03907930
NCT03907930Unknown不适用

Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
dose of analgesia used to control pain after the procedure

研究概览

简要总结

prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL

详细描述

Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications.

Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types.

This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the "tubeless" PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate

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
Triple (Participant, Care Provider, Investigator)

盲法说明

triple blinded study

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients above 18 years old
  • •Patients with any stone burden and stone number requiring single procedure

排除标准

  • •1 - Patients aged below 18 years old.
  • •Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation.
  • •Complex or staghorn stones requiring staged procedure.
  • •Intra operative criteria:
  • •Three or more access tracts.
  • •Significant intraoperative bleeding.
  • •Intraoperative pelvi calyceal system perforation.
  • •Residual stones necessitate 2nd look PNL

研究组 & 干预措施

conventional

Active Comparator

this arm will have both nephrostomy tube and ureteric catheter after completing the operation

干预措施: percutaneous nephrolithotripsy (Procedure)

tubeless

Active Comparator

the arm will have only ureteric catheter rafter completing the operation

干预措施: percutaneous nephrolithotripsy (Procedure)

结局指标

主要结局

dose of analgesia used to control pain after the procedure

时间窗: 5 days

comparison between the dose of analgesia needed for both groups in milligram

number of days of hospital stay for both groups

时间窗: 15 days

comparison between number of days in hospital for both groups

次要结局

未报告次要终点

研究者

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

Mohamed Ahmed Alsayed Ahmed Zowita

principal investigator

Assiut University

研究点 (1)

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