Clinical trial NCT02704949: Impact of Low Dose Fluoroscopy in Ureteroscopy
Official title: Impact of Low Dose Fluoroscopy in Ureteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Stone
Keywords: Urolithiasis
Fluoroscopy
Radiation
Ureteroscopy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: radiation exposure
timeFrame: 2 years
Secondary outcomes:
measure: stone free rate
timeFrame: 3 months
measure: complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Alexandre Danilovic, MD
role: PRINCIPAL_INVESTIGATOR
References: