The Role of Local Long Acting Corticosteroid Injection in... | NCT04196400

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

NCT04196400

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Dec 12, 2019Actual

Enrollment

40Estimated

Phase

Early Phase 1

Conditions

Hypospadias

Interventions

steroid betamethasone

Countries

Egypt

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Dec 9, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 12, 2019Actual

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

Dec 10, 2019

Last Update Posted Date

Dec 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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

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.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Steroid injection	Active Comparator	Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.	Drug: steroid betamethasone
Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
steroid betamethasone	Drug	The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair	Steroid injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Failure rate		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
incidence of Tissue edema		3 days, 5 days, 10 days, 2 weeks
Infection Rate		3 days, 5 days, 10 days, 2 weeks
Fistula rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo Univeristy Hospital		Cairo		002	Egypt

Type	Date	Date Unknown
Release	Sep 3, 2020
Reset	Sep 24, 2020

Submission Tracking

Estimated Results First Submitted Date

Sep 3, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 3, 2020			Sep 24, 2020

Condition Browse Module

MeSH Terms

ID	Term
D007021	Hypospadias
D004487	Edema
D005402	Fistula

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