Actively Recruiting

Phase Not Applicable
Age: 6Months +
MALE
ID06565286

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

Led by Sohag University · Updated on 2024-08-21

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Proximal hypospadias, including penoscrotal and scrotal types, represent about 20% of all hypospadias cases and present surgical challenges in achieving a straight, functional, and cosmetically favorable penis. This research compares two surgical techniques used in two-stage repair of primary proximal penile hypospadias. The study aims to address the ongoing debate about the best method to substitute the urethral plate in these complex cases. The trial evaluates outcomes of two different surgical approaches: the inner preputial graft and the transverse preputial island flap, both used in the first stage of a two-stage repair for proximal penile hypospadias. These methods are compared to see which yields better results in terms of complications and success rates. The inner preputial graft is noted for its versatility, especially in cases with limited healthy local skin, while the flap method offers a reliable blood supply potentially reducing strictures or contractures. Participants will undergo surgery with one of the two techniques and be closely monitored for complications and outcomes. Researchers will measure the rate of complications six months after the end of treatment to evaluate the success of each method. The study includes careful follow-up to assess both functional and cosmetic results, with the total participation spanning the treatment and post-treatment monitoring periods.

CONDITIONS

Brief Title

Graft Versus Flap in Management of Proximal Penile Hypospadias

Who Can Participate

Age: 6Months +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age more than 6 months
  • Diagnosis of proximal penile hypospadias, including scrotal and penoscrotal types
Not Eligible

You will not qualify if you...

  • Age less than 6 months
  • Perineal hypospadias
  • Circumcised patients
  • Previous hypospadias repair
  • Raised serum creatinine or coagulopathy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Duration of surgical treatment period

Participants undergo a two-stage surgical repair for proximal penile hypospadias using either an inner preputial graft or a transverse preputial island flap in the first stage, followed by immediate post-operative care.

Post-operative Follow-up

Duration - 6 months after end of treatment

Participants are monitored for complications and recovery after staged repair of proximal penile hypospadias.

Trial Site Locations

Total: 1 location

1

Sohag Faculty of Medicine

Sohag, Egypt

Actively Recruiting

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Research Team

A

ahmed abohammady, denominator

H

hazem elmoghazy, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial