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

December 10, 2019 updated by: Ahmed Abozamel, Cairo University

Prospective Comparative Trial to Assess the Role of Local Long Acting Steroid Injection After Hypospadias Surgery in Decreasing Complications and Preserving Better Cosmesis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 002
        • Cairo Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
ACTIVE_COMPARATOR: Steroid injection
Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.
Drug: steroid betamethasone
The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Failure rate
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of Tissue edema
Time Frame: 3 days, 5 days, 10 days, 2 weeks
3 days, 5 days, 10 days, 2 weeks
Infection Rate
Time Frame: 3 days, 5 days, 10 days, 2 weeks
3 days, 5 days, 10 days, 2 weeks
Fistula rate
Time Frame: 2 weeks
2 weeks
Final cosmesis
Time Frame: 3 days, 5 days, 10 days, 2 weeks
The shape of the glans penis and surrounding tissue
3 days, 5 days, 10 days, 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (ACTUAL)

December 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypospadias-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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