Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03817723
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2019-01-23
Brief Title:
Radiation Exposure in Intraoperative Cholangiography
Sponsor:
Jyväskylä Central Hospital
Organization:
Jyväskylä Central Hospital
Study Overview
Official Title:
Radiation Exposure of Intraoperative Cholangiography During Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None