Evaluation of Slit-like Adjusted Mathieu Versus Onlay Isl... | NCT07592026

Studies
Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics

NCT07592026

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

May 18, 2026Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Narrow Urethral Plate Hypospadias

Interventions

Slit-like Adjusted Mathieu
onlay island flap

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Oct 31, 2025Actual

Completion Date

Oct 31, 2025Actual

First Submitted Date

May 6, 2026

First Submission Date that Met QC Criteria

May 13, 2026

First Posted Date

May 18, 2026Actual

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

May 13, 2026

Last Update Posted Date

May 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Abdelmaboud, Associate professor of pediatric surgery, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Purpose** To compare the Slit-like Adjusted Mathieu (SLAM) technique versus the inner transverse preputial onlay island flap for repair of anterior and mid-penile hypospadias with narrow urethral plate, evaluating complication rates, surgical outcomes, and cosmetic results.
Methods** This prospective randomized controlled study included 80 patients with anterior and mid-penile hypospadias with a urethral plate <6 mm, conducted at Al-Azhar University Hospitals, Cairo, Egypt, from May 2020 to October 2025. Patients were randomly allocated to SLAM repair (Group A, n=40) or inner transverse preputial onlay island flap (Group B, n=40). Follow-up ranged from 24 to 48 months. Outcomes were assessed using the Hypospadias Objective Scoring Evaluation (HOSE) questionnaire.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SLAM repair	Active Comparator	Slit-like Adjusted Mathieu	Procedure: Slit-like Adjusted Mathieu
onlay island flap	Active Comparator	inner transverse preputial onlay island flap	Procedure: onlay island flap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slit-like Adjusted Mathieu	Procedure	Slit-like Adjusted Mathieu	SLAM repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative complications		Follow-up was performed at 1, 3, 12, and 24 months to assess complications

Secondary Outcomes

Measure	Description	Time Frame
Hypospadias Objective Scoring Evaluation score	a validated 5-point system, ranging from 5 to 16	at 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

anterior or mid-penile hypospadias
shallow and narrow urethral plate measuring <6 mm,
without or with mild penile curvature <30° after degloving

Exclusion Criteria:

wide urethral plate suitable for Tubularized Incised Plate (TIP) urethroplasty,
other types of hypospadias (penoscrotal, scrotal, or perineal),
moderate or severe penile curvature (>30°)
recurrent cases

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Years

Standard Ages

Child

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
Faculty of medicine for boys, Al-Azhar university		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007021	Hypospadias

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

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