NCT03404986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

January 14, 2018

Last Update Submit

December 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients treated effectively by the two methods

    1 hour

Study Arms (2)

Standardized ureteroscopy group

OTHER
Procedure: ureteroscopy

Ultrasonography ureteroscopy group

OTHER
Procedure: ureteroscopyRadiation: Ultrasonography

Interventions

ureteroscopyPROCEDURE

The patients will be subjected to rigid ureteroscopy

Standardized ureteroscopy groupUltrasonography ureteroscopy group

The patients will be subjected to Ultrasonography

Ultrasonography ureteroscopy group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with bilateral ureteric stones
  • Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
  • Previously failed ureteroscopy or previous ureteroneocystostomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Ureterolithiasis

Interventions

UreteroscopyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical ProceduresUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 14, 2018

First Posted

January 19, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

December 5, 2022

Record last verified: 2022-12

Locations