Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

Study Overview

• Status: Completed
• Conditions: Ureteral Calculi
• Intervention / Treatment: Procedure: ureteroscopy with safety guide-wire; Procedure: with safety guide-wire; Procedure: ureteroscopy alone; Procedure: without safety guide-wire

Detailed Description

While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehrān, Iran, Islamic Republic of
    • Shahid Beheshty University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ureteral stone who underwent ureteroscopy

Exclusion Criteria:

• transplant kidney
• coagulopathy disorders
• history of ureteral stenosis
• skeletal disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ureteroscopy with safety guide-wire; ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy	Procedure: ureteroscopy with safety guide-wire; ureteroscopy with use of safety guide-wire in treatment of ureteral stone; Procedure: with safety guide-wire; ureteroscopy with use of safety guide-wire in treatment of ureteral stone
Placebo Comparator: ureteroscopy alone; ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy	Procedure: ureteroscopy alone; ureteroscopy without use of safety guide-wire in treatment of ureteral stone; Procedure: without safety guide-wire; ureteroscopy without use of safety guide-wire in treatment of ureteral stone
Active Comparator: with safety guide-wire; ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy	Procedure: ureteroscopy with safety guide-wire; ureteroscopy with use of safety guide-wire in treatment of ureteral stone; Procedure: with safety guide-wire; ureteroscopy with use of safety guide-wire in treatment of ureteral stone
Placebo Comparator: without safety guide-wire; ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy	Procedure: ureteroscopy alone; ureteroscopy without use of safety guide-wire in treatment of ureteral stone; Procedure: without safety guide-wire; ureteroscopy without use of safety guide-wire in treatment of ureteral stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stone free rate	rate of patients without any residue of stone	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	the time between insertion of ureteroscopy till insertion of catheter	at time of surgery
grade of kidney hydronephrosis	grade of hydronephrosis is classified as: 0-4 grades	3 months after surgery
ureteral injury	ureteral injury is classified as: Mucosal abrasion, Ureteral perforation, Intussusception / avulsion	at time of surgery

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Study Chair: Abbas Basiri, prof, Shahid Beheshty University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: ureteroscopy; Ureteral Calculi; safety guide-wire
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: Q12133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No