Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

Study Overview
=================
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.

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

Conditions
-----------------
Kidney Stones, Urolithiasis

Intervention / Treatment
-----------------
* Procedure: Technologist control of fluoroscopy
* Procedure: Surgeon control of fluoroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fluoroscopy<br>Technologist control of fluoroscopy Surgeon control of fluoroscopy | Procedure: Technologist control of fluoroscopy<br>* Technologist control of fluoroscopy<br>Procedure: Surgeon control of fluoroscopy<br>* Surgeon control of fluoroscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urolithiasis, Kidney Stones, Ureteroscopy, Fluoroscopy