Back to resultsHemostasis During Hypospadias Surgery
Primary Purpose
Hypospadias Repair
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
tourniquet application
epinephrine injection
Sponsored by
About this trial
This is an interventional treatment trial for Hypospadias Repair focused on measuring hypospadias, dehiscence, urethral stricture, side effects
Eligibility Criteria
Inclusion Criteria:
- age under 15 Hypospadiasis ( Distal, Midshaft, Proximal)
Exclusion Criteria:
- Bleeding tendency Penoscrotal Hypospadiasis Other method
Sites / Locations
- Isfahan University of Medical scienceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypospadiasis repair
Arm Description
Outcomes
Primary Outcome Measures
Bleeding
Secondary Outcome Measures
fistula
Full Information
NCT ID
NCT02268019
First Posted
September 15, 2014
Last Updated
October 15, 2014
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02268019
Brief Title
Hemostasis During Hypospadias Surgery
Official Title
A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A comparison between the two hemostatic methods of hypospadias repairing operation, in terms of early and mid-term (up to 6 months) failure rate (wound dehiscence and urethral stricture needing reoperation) between the two groups: Group A) diluted Epinephrine injection, Group B) tourniquet application in children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias Repair
Keywords
hypospadias, dehiscence, urethral stricture, side effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypospadiasis repair
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
tourniquet application
Intervention Type
Drug
Intervention Name(s)
epinephrine injection
Primary Outcome Measure Information:
Title
Bleeding
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
fistula
Time Frame
after surgery for 6 months
Other Pre-specified Outcome Measures:
Title
meatal and neourethral stricture
Time Frame
after surgery for 6 months
Title
wound dehiscence
Time Frame
after surgery for 6 months
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- age under 15 Hypospadiasis ( Distal, Midshaft, Proximal)
Exclusion Criteria:
- Bleeding tendency Penoscrotal Hypospadiasis Other method
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farshid Alizadeh
Phone
+983136685555
Email
f_alizadeh@med.mui.ac.ir
Facility Information:
Facility Name
Isfahan University of Medical science
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Fakoor
Email
amir3982@yahoo.com
First Name & Middle Initial & Last Name & Degree
Farshid Alizadeh
12. IPD Sharing Statement
Learn more about this trial
Hemostasis During Hypospadias Surgery
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