Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

Sponsor

Boston Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02224287

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis Kidney Stones	Procedure: Technologist control of fluoroscopy Procedure: Surgeon control of fluoroscopy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Fluoroscopy Technologist control of fluoroscopy Surgeon control of fluoroscopy	Procedure: Technologist control of fluoroscopy Technologist control of fluoroscopy Procedure: Surgeon control of fluoroscopy Surgeon control of fluoroscopy

Arm

Intervention/Treatment

Other: Fluoroscopy

Technologist control of fluoroscopy Surgeon control of fluoroscopy

Procedure: Technologist control of fluoroscopy

Technologist control of fluoroscopy

Procedure: Surgeon control of fluoroscopy

Surgeon control of fluoroscopy

Outcome Measures

Primary Outcome Measures

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

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.