Impact of Low Dose Fluoroscopy in Ureteroscopy
Primary Purpose
Ureteral Stone
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
1/4 fluoroscopy dose
Full-dose
Sponsored by
About this trial
This is an interventional prevention trial for Ureteral Stone focused on measuring Urolithiasis, Fluoroscopy, Radiation, Ureteroscopy
Eligibility Criteria
Inclusion Criteria:
- ureteral stone from 5 mm to 20 mm in diameter by CT scan
Exclusion Criteria:
- abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system
Sites / Locations
- University of Sao Paulo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-dose
Full-dose
Arm Description
The intervention is to use 1/4 fluoroscopy dose while the ureteroscopy is being performed
The intervention is to use full fluoroscopy dose while the ureteroscopy is being performed
Outcomes
Primary Outcome Measures
radiation exposure
Each group of patients (1/4 dose and full dose) will have assigned one dosimeter to assess the radiation exposure every procedure. The sum of radiation of each group will be compared at the completion of the study (2 years) , because individual radiation exposure is too low to be measured. Radiation exposure will be measured (data stored inside the dosimeter) by dosimeter in mSv units at each procedure and the total sum of radiation will be done at the end of the study (2 years).
Secondary Outcome Measures
stone free rate
None residual fragment in the ureter identified by computed tomography 3 months after the procedure
complications
Clavien-Dindo surgical complication score
Full Information
NCT ID
NCT02704949
First Posted
February 17, 2016
Last Updated
September 28, 2021
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02704949
Brief Title
Impact of Low Dose Fluoroscopy in Ureteroscopy
Official Title
Impact of Low Dose Fluoroscopy in Ureteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
One of the most effective strategies to decrease radiation exposure during ureteroscopy is to use low dose. However, the quality of the image obtained is inferior to full dose image. The main concern is to maintain the stone free and complication rate despite the inferior quality of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead of full dose would impact in a reduction of total radiation exposure despite a possible increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone treatment due too less than optimal fluoroscopy image. All patients over 18 years old diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled regarding their treatment options. Patients who failed spontaneous passage or medical treatment or chose endourologic treatment were included in this study. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study.
Detailed Description
Several studies support an association between increasing cancer risk with increasing exposure to radiation. Typical radiation exposure for a patient submitted to ureteroscopy ranges from 2.5 to 100 mSv. The International Commission on Radiological Protection recommends an annual occupational radiation exposure limit of no more than 50 mSv per year. One of the most effective strategies to decrease radiation exposure during ureteroscopy is to use low dose. However, the quality of the image obtained is inferior to full dose image. The main concern is to maintain the stone free and complication rate despite the inferior quality of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead of full dose would impact in a reduction of total radiation exposure despite a possible increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone treatment due too less than optimal fluoroscopy image. All patients over 18 years old diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled regarding their treatment options. Patients who failed spontaneous passage or medical treatment or chose endourologic treatment were included in this study. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Stone
Keywords
Urolithiasis, Fluoroscopy, Radiation, Ureteroscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose
Arm Type
Experimental
Arm Description
The intervention is to use 1/4 fluoroscopy dose while the ureteroscopy is being performed
Arm Title
Full-dose
Arm Type
Active Comparator
Arm Description
The intervention is to use full fluoroscopy dose while the ureteroscopy is being performed
Intervention Type
Radiation
Intervention Name(s)
1/4 fluoroscopy dose
Intervention Description
Use of 1/4 fluoroscopy dose while ureteroscopy is being performed
Intervention Type
Radiation
Intervention Name(s)
Full-dose
Intervention Description
Use of full fluoroscopy dose while ureteroscopy is being performed
Primary Outcome Measure Information:
Title
radiation exposure
Description
Each group of patients (1/4 dose and full dose) will have assigned one dosimeter to assess the radiation exposure every procedure. The sum of radiation of each group will be compared at the completion of the study (2 years) , because individual radiation exposure is too low to be measured. Radiation exposure will be measured (data stored inside the dosimeter) by dosimeter in mSv units at each procedure and the total sum of radiation will be done at the end of the study (2 years).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
stone free rate
Description
None residual fragment in the ureter identified by computed tomography 3 months after the procedure
Time Frame
3 months
Title
complications
Description
Clavien-Dindo surgical complication score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ureteral stone from 5 mm to 20 mm in diameter by CT scan
Exclusion Criteria:
abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Danilovic, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Low Dose Fluoroscopy in Ureteroscopy
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