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临床试验/NCT05202158
NCT05202158Unknown不适用

A Novel Method for Stone Area Sterilization During Retrograde Intrarenal Surgery (RIRS)

Ankara Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
76
试验地点
2
主要终点
Rate of postoperative complications

研究概览

简要总结

In this prospective randomised controlled study, investigators aims to evaluate the effect of 80 mg gentamicin added to 3 liters of irrigation fluid on stone free rate, intraoperative and postoperative complications during RIRS for kidney stones.

详细描述

Current advances in endoscopic technology for the upper urinary tract have expanded the diagnosis and treatment options for kidney stones. Retrograde intrarenal surgery (RIRS), defined as the use of effective lithotripters such as flexible ureteroscopes (fURSs) and holmium:yttrium aluminum garnet (holmium:YAG) lasers for intrarenal pelvic diseases, is a safe and effective, versatile and minimally invasive procedure for the kidney. . Current guidelines for the treatment of kidney stones recommend RIRS first for stones <2 cm. and RIRS as one of the first two options for stones >2 cm.. In studies dealing with kidney stones larger than 2 cm, the RIRS showed a cumulative stone-free success of 91%, but a complication rate of 8.6%. Of these, 44% were found to be ≥ Clavien 3 complications. In kidney stone endourological treatments, stone culture was found to be more effective in predicting complications than midstream urine culture. Even if the preoperative midstream urine culture is sterile, complication rates increase if there is bacterial growth in the stone culture in kidney stone surgery. Therefore, although complication rates are generally low, several concerns have arisen. In our study, the investigators aims to evaluate the effect of 80 mg gentamicin added to 3 liters of irrigation fluid on stone free rate and complications during RIRS for kidney stones.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • <2 cm. kidney stones

排除标准

  • Ureteral stricture
  • Active urinary tract infection
  • Coagulopathies

结局指标

主要结局

Rate of postoperative complications

时间窗: One year

Rate of patients who had an complication after the operation

次要结局

未报告次要终点

研究者

发起方
Ankara Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Kaan Yildiz

Principal Investigator

Ankara Training and Research Hospital

研究点 (2)

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