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临床试验/NCT04557722
NCT04557722已完成不适用

The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy: Prospective Randomized Study

Menoufia University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
The puncture success rate and number of attempts

研究概览

简要总结

To analyze and compare the puncture success rate, puncture fluoroscopy time and intraoperative puncture complications of two different puncture techniques; fluoroscopic bi-planar (0-30º) versus newly reported bi-planar (0-90º) technique in PCNL.

详细描述

Nephrolithiasis is one of the most common urological diseases, it is a widespread and challenging issue for both patients and healthcare systems. It is responsible for a significant financial and psychological burden, with an increased incidence of disease. The EAU (European Association of Urology) Guidelines recommend percutaneous nephrolithotomy in patients with kidney stones >2 cm.

The most crucial step of the procedure is the precise puncture of the caliceal system. This can be accomplished by the use of fluoroscopy, ultrasound, or the combination of both and new other imaging modalities techniques. Among them, Fluoroscopy is the most common method for conducting the percutaneous puncture by urologists worldwide using multiple mono-planar or bi-planar fluoroscopic techniques.

However, all fluoroscopic approaches face the same limitation, which is the difficult interpretation of the three-dimensional renal anatomy based on the two-dimensional X-ray information. Another disadvantage is the amount of fluoroscopic radiation used. Surgeons, assistants, nurses and patients, however, all have to accept various levels of radiation exposure. Numerous researches have revealed that it is still harmful to the human body who is exposed to radiation frequently, although under the aegis of protective aprons and thyroid shields, thus the application is affected to varying degrees.

Fluoroscopic bi-planar techniques provide better information about the depth and direction of the collecting system than mono-planar methods. The most popular bi-planar methods described in the literature are the triangulation (0-30º), the "bull´s eye" technique and the less known bi-planar technique (The 0-90º technique) described by Dr. Paul Escovar. A newly published (0-90º) technique by Braulio O Manzo et al to increase the accuracy of calculating the needle path to the exact calyx depth and decreases its radiation exposure.

In the current study, the investigator aimed to compare two different renal access techniques; fluoroscopic 0-30 and modified 0-90 technique regarding success rate, fluoroscopy time and intraoperative puncture complications.

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
None

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

  • A patient over 18 years old.
  • Renal stone 2 cm or greater.

排除标准

  • A patient < 18 years old.
  • Congenital anomalies of the kidney: horseshoe kidney, malrotated kidney, pelvic ectopic kidney.
  • Patient with obvious spinal deformity.
  • Coagulopathies.

结局指标

主要结局

The puncture success rate and number of attempts

时间窗: intraoperative

percentage of patients in whom the renal puncture achieving desired calyx (evaluated by adequate introduction of the guidewire, bright urine output and stone accessibility).

次要结局

  • The Puncture fluoroscopy screening time(intraoperative)
  • Intraoperative puncture complications(intraoperative)

研究者

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

Ahmed Zakaria Ali Ibrahim Alshahawy

Principal Investigator

Menoufia University

研究点 (2)

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