Graft Versus Flap in Management of Proximal Penile Hypospadias

NCT ID: NCT06565286

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-18

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Proximal Penile Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Inlay inner preputial graft versus Transverse preputial island flap in management of proximal penile hypospadias
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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inner preputial graft

managemet of proximal penile hypospadias in 2stage using inner preputial graft in the first stage

Group Type ACTIVE_COMPARATOR

inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias

Intervention Type PROCEDURE

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 .

transverse preputial island flap

managemet of proximal penile hypospadias in 2stage using transverse preputial island flap in the first stage

Group Type ACTIVE_COMPARATOR

inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias

Intervention Type PROCEDURE

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 .

Interventions

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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 .

Intervention Type PROCEDURE

Other Intervention Names

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graft versus flap in two-stage repair of proximal penile hypospadias

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Shabaan Abohamady

assistant lecturer- urology departement - faculty of medicine -sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohamed diaa, professor

Role: STUDY_DIRECTOR

Sohag University

Locations

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Sohag Faculty of Medicine

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed abohammady, denominator

Role: CONTACT

01016631447

hazem elmoghazy, professor

Role: CONTACT

01096522289

Facility Contacts

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ahmed abo hammady, Denominator

Role: primary

01016631447

hazem elmoghazy, professor

Role: backup

01096522289

References

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Kojima Y, Kohri K, Hayashi Y. Genetic pathway of external genitalia formation and molecular etiology of hypospadias. J Pediatr Urol. 2010 Aug;6(4):346-54. doi: 10.1016/j.jpurol.2009.11.007. Epub 2009 Dec 7.

Reference Type RESULT
PMID: 19995686 (View on PubMed)

Bouty A, Ayers KL, Pask A, Heloury Y, Sinclair AH. The Genetic and Environmental Factors Underlying Hypospadias. Sex Dev. 2015;9(5):239-259. doi: 10.1159/000441988. Epub 2015 Nov 28.

Reference Type RESULT
PMID: 26613581 (View on PubMed)

Hsieh MH, Breyer BN, Eisenberg ML, Baskin LS. Associations among hypospadias, cryptorchidism, anogenital distance, and endocrine disruption. Curr Urol Rep. 2008 Mar;9(2):137-42. doi: 10.1007/s11934-008-0025-0.

Reference Type RESULT
PMID: 18419998 (View on PubMed)

Related Links

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http://pubmed.ncbi.nlm.nih.gov/19995686/

Genetic pathway of external genitalia formation and molecular etiology of hypospadias

http://pubmed.ncbi.nlm.nih.gov/26613581/

The Genetic and Environmental Factors Underlying Hypospadias

http://pubmed.ncbi.nlm.nih.gov/18419998/

Associations among hypospadias, cryptorchidism, anogenital distance, and endocrine disruption

Other Identifiers

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Soh-Med-24-06-02MD

Identifier Type: -

Identifier Source: org_study_id

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