Hemostasis During Hypospadias Surgery

Hypospadias Repair Clinical Trial

Official title:

A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02268019
• Other study ID #: IUMS2014
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2014
• Last updated: October 15, 2014
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2014
• Source: Isfahan University of Medical Sciences
• Contact: Farshid Alizadeh
• Phone: +983136685555
• Email: f_alizadeh[@]med.mui.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• age under 15 Hypospadiasis ( Distal, Midshaft, Proximal)

Exclusion Criteria:

• Bleeding tendency Penoscrotal Hypospadiasis Other method

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypospadias
• Hypospadias Repair

Intervention

Procedure:
• tourniquet application

Drug:
• epinephrine injection

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical science	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	meatal and neourethral stricture		after surgery for 6 months	Yes
Other	wound dehiscence		after surgery for 6 months	Yes
Primary	Bleeding		During surgery	Yes
Secondary	fistula		after surgery for 6 months	Yes