Hypospadias RepairNCT02268019
Hemostasis During Hypospadias Surgery
A study testing tourniquet application and epinephrine injection in people with Hypospadias Repair, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 Read more about this study
- Who is it for?
- Ages Up to 15 years, men only
- Conditions the study is for
- Hypospadias Repair
- What is being tested?
- tourniquet application and epinephrine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Jan 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- age under 15 Hypospadiasis ( Distal, Midshaft, Proximal)
Who cannot join
- Bleeding tendency Penoscrotal Hypospadiasis Other method
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Isfahan University of Medical science
Isfahan, Isfahan
Amir Fakoor, amir3982@yahoo.com
Farshid Alizadeh
About this study
Official title: A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome
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
- Conditions
- Hypospadias Repair
- Being tested
- tourniquet application, epinephrine injection
- Keywords
- hypospadias, dehiscence, urethral stricture, side effects
- Medical subject headings
- Hypospadias, Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquet applicationProcedure or surgery
epinephrine injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Hypospadiasis repair | Experimental | Not described Receives: Procedure: tourniquet application; Drug: epinephrine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Measured: During surgery
Secondary outcomes (1)
fistula
Measured: after surgery for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypospadias RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farshid Alizadeh, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268019
- Sponsor's protocol ID
- IUMS2014
- Status last verified
- Oct 2014
- First submitted
- 15 Sep 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome
- ClinicalTrials.gov ID
- NCT02268019
- Acronym / sponsor ID
- IUMS2014
- Conditions
- Hypospadias Repair
- Keywords
- hypospadias, dehiscence, urethral stricture, side effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypospadiasis repair | Experimental | Procedure: tourniquet application, Drug: epinephrine injection |
Who may qualify
- Ages
- Up to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- age under 15 Hypospadiasis ( Distal, Midshaft, Proximal)
Key exclusion criteria (1 listed)
- Bleeding tendency Penoscrotal Hypospadiasis Other method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tourniquet application | Procedure or surgery | Hypospadiasis repair |
| epinephrine injection | Drug | Hypospadiasis repair |
Primary outcome
Bleeding
Time frame: During surgery
1 secondary outcome
fistula
Time frame: after surgery for 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
Related trials for Hypospadias Repair
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
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Efficacy of PRF in Hypospadias Repair
Hypospadias
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Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair
Microsurgical, Single Dartos Flap
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Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
Hypospadias, Caudal Block
Not yet recruiting
Urethral Plate Flap vs. Tunica Vaginalis Flap for Residual Severe Ventral Curvature in Hypospadias
Residual Severe Ventral Curvature, Transection of the Urethral Plate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tourniquet application and epinephrine injection in people with Hypospadias Repair, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farshid Alizadeh (+983136685555, f_alizadeh@med.mui.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.