Hemostasis During Hypospadias Surgery | NCT02268019

Studies
Hemostasis During Hypospadias Surgery

NCT02268019

Sponsor

Isfahan University of Medical Sciences

Status

Unknown status

Last Update Posted

Oct 20, 2014Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Hypospadias Repair

Interventions

tourniquet application
epinephrine injection

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2015Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Sep 15, 2014

First Submission Date that Met QC Criteria

Oct 15, 2014

First Posted Date

Oct 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2014

Last Update Posted Date

Oct 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Farshid Alizadeh, Assistant professors of medical science, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypospadiasis repair	Experimental		Procedure: tourniquet application Drug: epinephrine injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tourniquet application	Procedure		Hypospadiasis repair
epinephrine injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding		During surgery

Secondary Outcomes

Measure	Description	Time Frame
fistula		after surgery for 6 months

Other Outcomes

Measure	Description	Time Frame
meatal and neourethral stricture		after surgery for 6 months
wound dehiscence		after surgery for 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Bleeding tendency Penoscrotal Hypospadiasis Other method

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Farshid Alizadeh	Contact	+983136685555		f_alizadeh@med.mui.ac.ir

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isfahan University of Medical science	Recruiting	Isfahan	Isfahan		Iran

Condition Browse Module

MeSH Terms

ID	Term
D007021	Hypospadias
D014525	Urethral Stricture

Ancestor Terms

ID	Term
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004837	Epinephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided