Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

NCT ID: NCT02224287

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urolithiasis Kidney Stones

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fluoroscopy

Technologist control of fluoroscopy Surgeon control of fluoroscopy

Group Type OTHER

Technologist control of fluoroscopy

Intervention Type PROCEDURE

Technologist control of fluoroscopy

Surgeon control of fluoroscopy

Intervention Type PROCEDURE

Surgeon control of fluoroscopy

Interventions

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Technologist control of fluoroscopy

Technologist control of fluoroscopy

Intervention Type PROCEDURE

Surgeon control of fluoroscopy

Surgeon control of fluoroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Caleb Nelson

Caleb Nelson MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caleb Nelson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30257794 (View on PubMed)

Other Identifiers

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P00003145

Identifier Type: -

Identifier Source: org_study_id

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