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

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03726502

Collaborator

(none)

300

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi	Procedure: ureteroscopy with safety guide-wire Procedure: ureteroscopy alone Procedure: without safety guide-wire Procedure: with safety guide-wire	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

stone free rate [3 months after surgery]
rate of patients without any residue of stone

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ureteral stone who underwent ureteroscopy

Exclusion Criteria:

transplant kidney
coagulopathy disorders
history of ureteral stenosis
skeletal disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shahid beheshty university of medical sciences	Tehrān		Iran, Islamic Republic of

Sponsors and Collaborators

Isfahan University of Medical Sciences

Investigators

Study Chair: Abbas Basiri, prof, Shahid beheshty university of medical sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hamidreza Shemshaki, Director, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT03726502

Other Study ID Numbers:

Q12133

First Posted:

Oct 31, 2018

Last Update Posted:

Dec 19, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hamidreza Shemshaki, Director, Isfahan University of Medical Sciences

Ureteral Calculi

safety guide-wire

ureteroscopy

Additional relevant MeSH terms:

Ureteral Calculi

Ureterolithiasis

Calculi

Study Results

No Results Posted as of Dec 19, 2018