NCT04196400

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.

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
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2019

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

December 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

December 9, 2019

Last Update Submit

December 10, 2019

Conditions

Hypospadias

Keywords

hypospadias, edema, failure, fistula, steroids

Outcome Measures

Primary Outcomes (1)

  • Failure rate

    2 weeks

Secondary Outcomes (4)

  • incidence of Tissue edema

    3 days, 5 days, 10 days, 2 weeks

  • Infection Rate

    3 days, 5 days, 10 days, 2 weeks

  • Fistula rate

    2 weeks

  • Final cosmesis

    3 days, 5 days, 10 days, 2 weeks

Study Arms (2)

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

steroid betamethasoneDRUG

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

Steroid injection

Eligibility Criteria

Age6 Months+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Univeristy Hospital

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

HypospadiasEdemaFistula

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 AbnormalitiesSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: comparative prospective clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Lecturer in Urology department

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 12, 2019

Study Start

December 1, 2019

Primary Completion

December 31, 2020

Study Completion

March 1, 2021

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

EG(1)