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Trial record 38 of 117 for:    "Penile Disease"

Hemostasis During Hypospadias Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02268019
Recruitment Status : Unknown
Verified October 2014 by Farshid Alizadeh, Isfahan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Farshid Alizadeh, Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Hypospadias Repair Procedure: tourniquet application Drug: epinephrine injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome
Study Start Date : January 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypospadiasis repair Procedure: tourniquet application
Drug: epinephrine injection



Primary Outcome Measures :
  1. Bleeding [ Time Frame: During surgery ]

Secondary Outcome Measures :
  1. fistula [ Time Frame: after surgery for 6 months ]

Other Outcome Measures:
  1. meatal and neourethral stricture [ Time Frame: after surgery for 6 months ]
  2. wound dehiscence [ Time Frame: after surgery for 6 months ]


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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Bleeding tendency Penoscrotal Hypospadiasis Other method


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268019


Contacts
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Contact: Farshid Alizadeh +983136685555 f_alizadeh@med.mui.ac.ir

Locations
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Iran, Islamic Republic of
Isfahan University of Medical science Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Amir Fakoor       amir3982@yahoo.com   
Principal Investigator: Farshid Alizadeh         
Sponsors and Collaborators
Isfahan University of Medical Sciences

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Responsible Party: Farshid Alizadeh, Assistant professors of medical science, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02268019     History of Changes
Other Study ID Numbers: IUMS2014
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014

Keywords provided by Farshid Alizadeh, Isfahan University of Medical Sciences:
hypospadias
dehiscence
urethral stricture
side effects

Additional relevant MeSH terms:
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Penile Diseases
Hypospadias
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Epinephrine
Racepinephrine
Epinephryl borate
Hemostatics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Coagulants