NCT05913128

Brief Summary

To compare Glandular Urethral Disassembly technique versus Tubularized Incised Plate technique for Primary Distal Hypospadius 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
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

March 28, 2023

Last Update Submit

June 17, 2023

Conditions

Glandular Urethral DisassemblyTubularized Incised PlateDistal Hypospadius Repair

Keywords

Glandular Urethral Disassembly, Tubularized Incised Plate, Distal Hypospadius

Outcome Measures

Primary Outcomes (1)

  • Hospital stay

    Hospital stay will be recorded in days.

    up to14 days

Study Arms (2)

First arm

ACTIVE COMPARATOR

Glandular Urethral Disassembly technique

Procedure: Glandular Urethral Disassembly technique

Second arm

ACTIVE COMPARATOR

Tubularized Incised Plate technique

Procedure: Glandular Urethral Disassembly technique

Interventions

Glandular Urethral Disassembly techniquePROCEDURE

For Primary Distal Hypospadius Repair

Also known as: Tubularized Incised Plate technique
First armSecond arm

Eligibility Criteria

Age6 Months - 6 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Primary Distal Hypospadius

You may not qualify if:

  • secondary Distal Hypospadius Recurrent Hypospadius

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Banhā, Qalyubia Governorate, 74111, Egypt

RECRUITING

Study Officials

  • Ahmed AE Abdel Fattah, PhD

    faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed AE Abdel Fattah, PhD

CONTACT

01228555403ahmed.aboelezz@fmed.bu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of urology

Study Record Dates

First Submitted

March 28, 2023

First Posted

June 22, 2023

Study Start

July 30, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

EG(1)