Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control
1 other identifier
interventional
74
1 country
1
Brief Summary
This is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose parameters (cumulative absorbed dose and dose area product). From exposure data, entrance skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in this study will be total fluoroscopy time for the procedure. A secondary outcome will be the ESD. The investigators will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and ESD. It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating surgeon is controlling the activation of the x-ray beam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 20, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJune 29, 2020
April 1, 2017
4 years
August 20, 2014
June 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome in this study will be total fluoroscopy time for the procedure.
The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
1-5 hours
Secondary Outcomes (1)
A secondary outcome will be the entrance skin dose (mGy). We will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and entrance skin dose.
1-5 hours
Study Arms (1)
Fluoroscopy
OTHERTechnologist control of fluoroscopy Surgeon control of fluoroscopy
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing ureteroscopy for urolithiasis
- years to 25 years old
You may not qualify if:
- Pregnant
- Less than 5 years old or older than 25 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Kokorowski PJ, Chow JS, Cilento BG Jr, Kim DS, Kurtz MP, Logvinenko T, MacDougall RD, Nelson CP. The effect of surgeon versus technologist control of fluoroscopy on radiation exposure during pediatric ureteroscopy: A randomized trial. J Pediatr Urol. 2018 Aug;14(4):334.e1-334.e8. doi: 10.1016/j.jpurol.2018.04.035. Epub 2018 Jun 27.
PMID: 30257794DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caleb Nelson, MD, MPH
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Caleb Nelson MD, MPH
Study Record Dates
First Submitted
August 20, 2014
First Posted
August 25, 2014
Study Start
January 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
June 29, 2020
Record last verified: 2017-04