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The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.

NCT ID: NCT04196400

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-03-01

Brief Summary

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Post-operative tissue oedema is one of the main causes of failure of hypospadias repair. Severe oedema may disrupt the suture line, invite infection and result in repair failure. Thus, we suggested that local injection of corticosteroids in just below coronal sulcus into dartos and buck's fascia may limit this oedema thus improving the outcome of hypospadias repair.

Detailed Description

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This is a prospective comparative trial : comparing the use of local steroids injection to reduce tissue edema after hypospadias and to preserve the final cosmesis after tissue repair.

The patients will be divided into 2 groups(each group 20 patients): one group will be injected steroids just after hypospadias surgery while the other will not.

The short and long term outcomes between both groups will be compared.

Conditions

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Hypospadias

Keywords

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hypospadias, edema, failure, fistula, steroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

comparative prospective clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Steroid injection

Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.

Group Type ACTIVE_COMPARATOR

steroid betamethasone

Intervention Type DRUG

The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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steroid betamethasone

The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypospadias Patient
* Recurrent Cases
* 6 months or more
* Distal, and mid penile hypospadias

Exclusion Criteria

* None
Minimum Eligible Age

6 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abozamel

Doctor Lecturer in Urology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo Univeristy Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Hypospadias-101

Identifier Type: -

Identifier Source: org_study_id