Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

Urolithiasis Clinical Trial

Official title:

Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224287
• Other study ID #: P00003145
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Urolithiasis

Intervention

Procedure:
• Technologist control of fluoroscopy
Technologist control of fluoroscopy
• Surgeon control of fluoroscopy
Surgeon control of fluoroscopy

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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