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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteric Stone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
  2. Age group 18 years old or above.
  3. Stone size 15 mm or less.

Exclusion Criteria:

  1. Patients with bilateral ureteric stones
  2. Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
  3. 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

First Posted
January 14, 2018
Last Updated
December 2, 2022
Sponsor
Assiut University
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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

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Ultrasound Guided Ureteroscopy and Ureteric Stones

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