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Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

Primary Purpose

Urolithiasis, Kidney Stones

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technologist control of fluoroscopy
Surgeon control of fluoroscopy
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring Urolithiasis, Kidney Stones, Ureteroscopy, Fluoroscopy

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fluoroscopy

Arm Description

Technologist control of fluoroscopy Surgeon control of fluoroscopy

Outcomes

Primary Outcome Measures

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.

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

Full Information

First Posted
August 20, 2014
Last Updated
June 25, 2020
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02224287
Brief Title
Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control
Official Title
Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Kidney Stones
Keywords
Urolithiasis, Kidney Stones, Ureteroscopy, Fluoroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoroscopy
Arm Type
Other
Arm Description
Technologist control of fluoroscopy Surgeon control of fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
Technologist control of fluoroscopy
Intervention Description
Technologist control of fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
Surgeon control of fluoroscopy
Intervention Description
Surgeon control of fluoroscopy
Primary Outcome Measure Information:
Title
The primary outcome in this study will be total fluoroscopy time for the procedure.
Description
The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
Time Frame
1-5 hours
Secondary Outcome Measure Information:
Title
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.
Description
The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
Time Frame
1-5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caleb Nelson, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30257794
Citation
Kokorowski PJ, Chow JS, Cilento BG Jr, Kim DS, Kurtz MP, Logvinenko T, MacDougall RD, Nelson CP. The effect of surgeon versus technologist control of fluoroscopy on radiation exposure during pediatric ureteroscopy: A randomized trial. J Pediatr Urol. 2018 Aug;14(4):334.e1-334.e8. doi: 10.1016/j.jpurol.2018.04.035. Epub 2018 Jun 27.
Results Reference
derived

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Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

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