NCT05253456

Brief Summary

to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

February 14, 2022

Last Update Submit

February 14, 2022

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

  • urethro-cutaneous fistula

    presence of urethro-cutaneous fistula after closure of hypospadias as assess by inspection for the presence of urinary fistula

    1 year follow up

Study Arms (1)

intervention group

EXPERIMENTAL

patients underwent our newly modified technique for hypospadias repair

Procedure: Derma -Dartos Flap for second layer closure

Interventions

Derma -Dartos Flap for second layer closurePROCEDURE

usage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients

intervention group

Eligibility Criteria

Age1 Year - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHypospadias is congenital urethra defect in male urethra only
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All male patient with distal penile hypospadias aged less than 18

You may not qualify if:

  • Patients with penile rotation or hypoplastic urethral plate were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maher

Cairo, Cairo Governorate, 11757, Egypt

Location

MeSH Terms

Conditions

Hypospadias

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 Abnormalities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 23, 2022

Study Start

March 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 2, 2020

Last Updated

February 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)