Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

Not Applicable

Completed

• Conditions: Urolithiasis; Kidney Stones
• Interventions: Procedure: Technologist control of fluoroscopy; Procedure: Surgeon control of fluoroscopy

• Registration Number: NCT02224287
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients undergoing ureteroscopy for urolithiasis
• 5 years to 25 years old

Exclusion Criteria

• Pregnant
• Less than 5 years old or older than 25 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluoroscopy	Technologist control of fluoroscopy	Technologist control of fluoroscopy Surgeon control of fluoroscopy
Fluoroscopy	Surgeon control of fluoroscopy	Technologist control of fluoroscopy Surgeon control of fluoroscopy

Primary Outcome Measures

Name	Time	Method
The primary outcome in this study will be total fluoroscopy time for the procedure.	1-5 hours	The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.

Secondary Outcome Measures

Name	Time	Method
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	The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States