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Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02224287
Enrollment
74
Registered
2014-08-25
Start date
2013-01-31
Completion date
2017-01-31
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones, Urolithiasis

Keywords

Urolithiasis, Kidney Stones, Ureteroscopy, Fluoroscopy

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.

Interventions

PROCEDURETechnologist control of fluoroscopy

Technologist control of fluoroscopy

PROCEDURESurgeon control of fluoroscopy

Surgeon control of fluoroscopy

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome in this study will be total fluoroscopy time for the procedure.1-5 hoursThe average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026