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临床试验/NCT03060837
NCT03060837Unknown不适用

To Investigate the Effect of Reducing Renal Movement by Single Lung Ventilation in Patients Administered Retrograde Infrarenal Surgery (RIRS) for Kidney Stones on Operative and Postoperative Parameters

Kahramanmaras Sutcu Imam University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Changes in renal stone position during ventilation

研究概览

简要总结

In patients undergoing RIRS for kidney stone, we aim to show the effect of single lung ventilation with a double lumen tube on operative (operation scope duration, perforation, hemorrhage, etc. complications) and postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc.) and to show changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

详细描述

In recent years open surgical treatment has changed to minimal invasive treatments for kidney stone treatment. Additionally, the treatment choices vary depending on the localization of the stone and its dimensions. In the European Urology Association (EUA) guidelines, it states the RIRS method can be used to treat stones up to 2 cm in the kidney. Due to RIRS the operation and scopy durations and hospital stay have clearly reduced compared to the standard treatment of percutaneous nephrolithotomy. However, the high hydrostatic pressure applied to the renal pelvis during RIRS may cause unwanted results in the postoperative period such as hydronephrosis and loss of renal parenchyma. During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation and scope durations and brings risks such as perforation during laser lithotripsy application. In this study we aimed to apply single lung ventilation during the operation (one of the indications for single lung ventilation is to increase surgical view and ease manipulation) to minimize renal movement on that side and reduce peroperative and postoperative complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, 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

  • Older than 18 years
  • ASA (American Society of Anesthesiologists) 1-3
  • Patients with 2-3 cm stones in kidneys

排除标准

  • Patients with staghorn stones in kidneys
  • Patients with urinary system anomalies
  • Removal Criteria :
  • Difficult airway
  • Patients with carinal, bronchial lesions
  • Patients with bad general situation
  • Patients younger than 18 years
  • Satiated patients

结局指标

主要结局

Changes in renal stone position during ventilation

时间窗: 1-2 Hours

During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation. Preoperative and postoperative Scope will be used to evolve the renal movement. The values will be recorded in milimeters by comparing it.

次要结局

  • Total anesthesia duration(1-2 Hours)
  • Scope duration(10-30 Seconds)
  • Hospital stay(1-3 Days)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ömer Faruk Boran

Assistant Professor

Kahramanmaras Sutcu Imam University

研究点 (2)

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