Graft Versus Flap in Management of Proximal Penile Hypospadias

August 20, 2024 updated by: Ahmed Shabaan Abohamady, Sohag University

Inlay Inner Preputial Graft Versus Transverse Preputial Island Flap in Management of Proximal Penile Hypospadias

Proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. However, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the Holy Grail for hypospadias specialists.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The surgical plan for proximal hypospadias can be divided into single and staged operations. Single stage operations are often associated with high rates of complications and reoperations. Reportedly, complications occur in 20-50% of patients. Therefore, many pediatric surgeons are selecting staged procedures. Staged surgical repair of proximal forms of hypospadias has been proven to achieve successful both functional and cosmetic results. Although staged repair with inner preputial layer graft has regained popularity in the repair of proximal hypospadias; but Choosing between flaps or grafts to substitute the urethral plate in 2-stage hypospadias repair has been a matter of debate with no consensus in the literature.

Flaps have reliable blood supply that may be theoretically less liable for strictures or contractures. Grafts are more versatile, which can be used in primary and recurrent cases when healthy local skin is deficient.

In this study, our aim is to compare outcomes of grafts and flaps when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias (penoscrotal and scrotal types).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag Faculty of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: more than 6 months.
  • Type of hypospadias: proximal penile hypospadias (scrotal and penoscrotal variants)

Exclusion Criteria:

  • Age: less than 6 months.
  • Perineal hypospadias.
  • circumcised patients.
  • Previous hypospadias repair
  • Raised serum creatinine, coagulopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: inner preputial graft
managemet of proximal penile hypospadias in 2stage using inner preputial graft in the first stage
Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias
compare outcomes of inner preputial graft versus transverse preputial island flap when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias .
Other Names:
  • graft versus flap in two-stage repair of proximal penile hypospadias
Active Comparator: transverse preputial island flap
managemet of proximal penile hypospadias in 2stage using transverse preputial island flap in the first stage
Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias
compare outcomes of inner preputial graft versus transverse preputial island flap when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias .
Other Names:
  • graft versus flap in two-stage repair of proximal penile hypospadias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure complications after staged repair of proximal penile hypospadias using different techniques.
Time Frame: 6 month after end of treatment
urinary fistulas, urethral strictures, diverticula and failed repair.
6 month after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: mohamed diaa, professor, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-06-02MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Report the cosmotic and functional outcomes after staged repair of proximal penile hypospadias using different techniques.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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