NCT02268019

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

September 15, 2014

Last Update Submit

October 15, 2014

Conditions

Hypospadias Repair

Keywords

hypospadiasdehiscenceurethral strictureside effects

Outcome Measures

Primary Outcomes (1)

  • Bleeding

    During surgery

Secondary Outcomes (1)

  • fistula

    after surgery for 6 months

Other Outcomes (2)

  • meatal and neourethral stricture

    after surgery for 6 months

  • wound dehiscence

    after surgery for 6 months

Study Arms (1)

Hypospadiasis repair

EXPERIMENTAL
Procedure: tourniquet applicationDrug: epinephrine injection

Interventions

tourniquet applicationPROCEDURE
Hypospadiasis repair
epinephrine injectionDRUG
Hypospadiasis repair

Eligibility Criteria

AgeUp to 15 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • \- Bleeding tendency Penoscrotal Hypospadiasis Other method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical science

Isfahan, Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

HypospadiasUrethral Stricture

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrethral ObstructionUrethral DiseasesUrologic Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Farshid Alizadeh

CONTACT

+983136685555f_alizadeh@med.mui.ac.ir

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professors of medical science

Study Record Dates

First Submitted

September 15, 2014

First Posted

October 20, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

IR(1)