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临床试验/NCT03980444
NCT03980444已完成不适用

Determine the Effectiveness of Convective Uses of Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones

Mohammad Sadegh Bagheri Baghdasht2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2015年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
2
主要终点
Stone size

研究概览

简要总结

Patients included in the study included the necessary tests U / A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. Patients were prepared for action. The demographic and clinical data of the patients, including age, sex, size, and location of the stones were recorded.

Then patients as random allocation were divided into two groups: A (control group, no basket of bases and group B (use of pneumatic synchronous buccal waist). The dividing person and the patients themselves were not aware of which group they were in. They were double-blind was.

In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.

During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion.

In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the ureteroscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as the control group. Ureteroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered.

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
Single (Investigator)

盲法说明

patients as random allocation were divided into two groups: A (control group, no basket of bases and group B (use of pneumatic synchronous buccal waist). The dividing person and the patients themselves were not aware of which group they were in. They were double-blind Was.

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individual interest in engaging in research
  • •Patients with ureter stones
  • •Symptoms of severe and resistant to supportive and therapeutic treatment
  • •Ureteral stones cause ureteral obstruction
  • •Ureteral stones, which is not likely to be disposed of by duration and size, have been selected for ureteroscopic lithotripsy.

排除标准

  • •Patients with urinary tract infection
  • •Not having a proper cardiovascular condition and not approved by a cardiologist or anesthetist
  • •Patients who are dissatisfied with ureteroscopic crushing and patients who do not have access to rocks during ureteroscopic surgery
  • •Individual interest in leaving the study

研究组 & 干预措施

control group, no basket of wire

Experimental

The dividing person and the patients themselves were not aware of which group they were in. They were double-blind Was.

In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.

During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion.

干预措施: control group, no basket (Procedure)

using a basket of wires

Sham Comparator

In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as control group. Urethroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered

干预措施: Basket of wire (Device)

结局指标

主要结局

Stone size

时间窗: 24 hours

The largest diameter of the stone in the imaging of millimeters

Crushing time

时间窗: up to 23minute

Duration needed to break the stone to the minute

Demographic questionnaire

时间窗: 24 hours

The demographic questionnaire was used to collect information

Troma in the ureter area

时间窗: up to 24 hours

Follow up of patients for perforation, missing stone, and ureter ligation according to observations during and after surgery

次要结局

未报告次要终点

研究者

发起方
Mohammad Sadegh Bagheri Baghdasht
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohammad Sadegh Bagheri Baghdasht

student research committee

Baqiyatallah Medical Sciences University

研究点 (2)

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