Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair

NCT ID: NCT06808139

Last Updated: 2025-02-05

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-05-01

Brief Summary

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Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

Detailed Description

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Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

Conditions

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Penile Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Plasma-Rich Platelet Graft

Group Type ACTIVE_COMPARATOR

Plasma-Rich Platelet Graft

Intervention Type PROCEDURE

The clot was extracted from the tube, separated from red blood cells, and gently compressed between two surgical swabs to obtain a soft and resistant membrane. The Snodgrass technique was carried out for all patients, with a suitable size catheter (8-12-Fr), repair was carried out by a continuous layer of polyglycolic suture (Vicryl) size 6/0, covered by an interrupted second layer. In group A, after finishing the Snodgrass TIPU, a PRP sheet coverage was applied over urethroplasty and secured by Vicryl 7/0, and finally the skin sutured directly without any covering layers

Group B

Dartos Flap

Group Type ACTIVE_COMPARATOR

Dartos Flap

Intervention Type PROCEDURE

preputial dartos flap will be used

Interventions

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Plasma-Rich Platelet Graft

The clot was extracted from the tube, separated from red blood cells, and gently compressed between two surgical swabs to obtain a soft and resistant membrane. The Snodgrass technique was carried out for all patients, with a suitable size catheter (8-12-Fr), repair was carried out by a continuous layer of polyglycolic suture (Vicryl) size 6/0, covered by an interrupted second layer. In group A, after finishing the Snodgrass TIPU, a PRP sheet coverage was applied over urethroplasty and secured by Vicryl 7/0, and finally the skin sutured directly without any covering layers

Intervention Type PROCEDURE

Dartos Flap

preputial dartos flap will be used

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>6 months
* Distal penile hypospadias
* Denovo hypospadias

Exclusion Criteria

* Recurrent hypospadias -Mid and proximal penile hypospadias
Minimum Eligible Age

6 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed ali amen diab

residant doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmed ali amen diab, residant doctor

Role: CONTACT

+201023222678

Other Identifiers

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PRPgraft/DartosflapHypospadias

Identifier Type: -

Identifier Source: org_study_id

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