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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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
1/4 fluoroscopy dose
Use of 1/4 fluoroscopy dose while ureteroscopy is being performed
Full-dose
Use of full fluoroscopy dose while ureteroscopy is being performed

Locations

Country Name City State
Brazil University of Sao Paulo General Hospital Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 2 years
Secondary stone free rate None residual fragment in the ureter identified by computed tomography 3 months after the procedure 3 months
Secondary complications Clavien-Dindo surgical complication score 3 months
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