Ultrasound Guided Ureteroscopy and Ureteric Stones
Primary Purpose
Ureteric Stone
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ureteroscopy
Ultrasonography
Sponsored by
About this trial
This is an interventional treatment trial for Ureteric Stone
Eligibility Criteria
Inclusion Criteria:
- Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
- Age group 18 years old or above.
- Stone size 15 mm or less.
Exclusion Criteria:
- Patients with bilateral ureteric stones
- Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
- Previously failed ureteroscopy or previous ureteroneocystostomy.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Standardized ureteroscopy group
Ultrasonography ureteroscopy group
Arm Description
Outcomes
Primary Outcome Measures
Number of patients treated effectively by the two methods
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03404986
Brief Title
Ultrasound Guided Ureteroscopy and Ureteric Stones
Official Title
Ultrasound Guided Ureteroscopy for the Treatment of Lower Third Ureteric Stones in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent alternative for upper urinary tract imaging because it is radiation free, rapid, portable and allows excellent visualization of the renal pelvis and calyces. There is increasing awareness and concern about the clinical use of ionizing radiation and the need to decrease exposure of patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and children- in whom fluoroscopy is to be minimized or avoided when possible - has been reported.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteric Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standardized ureteroscopy group
Arm Type
Other
Arm Title
Ultrasonography ureteroscopy group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
ureteroscopy
Intervention Description
The patients will be subjected to rigid ureteroscopy
Intervention Type
Radiation
Intervention Name(s)
Ultrasonography
Intervention Description
The patients will be subjected to Ultrasonography
Primary Outcome Measure Information:
Title
Number of patients treated effectively by the two methods
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
Age group 18 years old or above.
Stone size 15 mm or less.
Exclusion Criteria:
Patients with bilateral ureteric stones
Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
Previously failed ureteroscopy or previous ureteroneocystostomy.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Guided Ureteroscopy and Ureteric Stones
We'll reach out to this number within 24 hrs