Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02704949 |
| Other study ID # |
13788 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2015 |
| Est. completion date |
May 2018 |
Study information
| Verified date |
February 2016 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 ΒΌ 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.
