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临床试验/NCT03817723
NCT03817723已完成不适用

Radiation Exposure of Intraoperative Cholangiography During Cholecystectomy

Jyväskylä Central Hospital1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
324
试验地点
1
主要终点
mean kerma area product (KAP)

研究概览

简要总结

Aims: to determine the radiation exposure of routine intraoperative cholangiography (IOC )during cholecystectomy and examine the factors affecting radiation dose and fluoroscopy time (FT).

Methods: 598 intraoperative cholangiography examinations were performed at the Central Finland Central Hospital. In this study we included 324 intraoperative cholangiographies performed with c-arm equipment not exceeding 10 years of age.

详细描述

From January 2016 to December 2017, consecutive 598 intraoperative cholangiography examinations were performed at the Central Finland Central Hospital. In this study we included 353 cholangiographies, that were performed with our c-arm equipment not exceeding 10 years of age in the beginning of 2016. The main measures of outcome were the recorded radiation dose data of c-arm systems from our manual database .

Another 25 cases were excluded because it was not possible to cross-check the manually recorded radiation dose data from the Picture Archiving and Communication System (PACS ). Additional 4 patients who underwent intraoperative endoscopic retrograde cholangiopancreatography (ERCP) were removed from the radiation exposure analysis because IOC and ERCP were performed consequently with the same c-arm and the radiation exposure of IOC could not be separated from the registered total KAP and FT. Thus the final analysis consisted of 324 IOCs. KAP (Kerma area product) is the product of air Kerma in the center of the imaging area multiplied with size of the imaging area. For simplicity we have unified varying units received from different c-arms and will only use Gray multiplied by square centimeters (Gycm2 ). KAP values were measured using inbuilt ionization chambers in c-arms. For this study we collected the KAP values from exposure and pulsed fluoroscopy. We also recorded the fluoroscopy time (s).

Laparoscopic cholecystectomies were performed both by residents and specialist surgeons.

Ethics: No ethical approval or written informed consent were needed because the study was retrospective in nature. The study was approved by the hospital administration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Consecutive intraoperative cholangiographies performed with c-arm equipment not exceeding 10 years of age between January 2016 to December 2017

排除标准

  • intraoperative cholangiographies performed with c-arm equipment exceeding over 10 years of age between January 2016 to December 2017
  • patients who underwent intraoperative endoscopic retrograde cholangiopancreatography (ERCP)
  • if the manually recorded radiation dose data could not be cross-checked from the Picture Archiving and Communication System ( PACS ) system

结局指标

主要结局

mean kerma area product (KAP)

时间窗: 2 years

KAP values were measured using inbuilt ionization chambers in c-arms.

次要结局

  • mean fluoroscopy time (FT )(2 years)

研究者

发起方
Jyväskylä Central Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olli Helminen

M.D, Ph.D.

Jyväskylä Central Hospital

研究点 (1)

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