Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

June 25, 2020 updated by: Caleb Nelson, Boston Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

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.
Time Frame: 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.
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.
Time Frame: 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.
1-5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00003145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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