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CompletedNCT03404986Updated Dec 5, 2022

Ultrasound Guided Ureteroscopy and Ureteric Stones

An interventional study of ureteroscopy and Ultrasonography in Ureteric Stone, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ureteric Stone
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Other
    Standardized ureteroscopy group

    Procedure: ureteroscopy

  • Other
    Ultrasonography ureteroscopy group

    Procedure: ureteroscopy · Radiation: Ultrasonography

Interventions

  • Procedureureteroscopy

    The patients will be subjected to rigid ureteroscopy

  • RadiationUltrasonography

    The patients will be subjected to Ultrasonography

05

What researchers measure

Primary outcomes

  1. Number of patients treated effectively by the two methods

    Time frame: 1 hour

06

Study locations

1 site
  • Women Health Hospital - Assiut university
    Assiut, 71111, Egypt
07

Registry details

Key details

Study ID
NCT03404986
Lead sponsor
Assiut University
Responsible party
Mohamed Loay (Resident, Assiut University) — Principal investigator
First posted
Jan 19, 2018
Start date
Apr 1, 2018
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Last update
Dec 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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