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Not yet recruiting NCT06808139

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

No phase Interventional Penile Hypospadias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma-Rich Platelet Graft, Dartos Flap.
Who it may be relevant to
Registry conditions: Penile Hypospadias. Basic parameters: from 6 months · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Interventions

  • Procedure 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
  • Procedure Dartos Flap
    preputial dartos flap will be used

Primary outcome measures

  • incidence of occurrence of uretherocutanous fistula [Time frame: 6 month]

Eligibility criteria

Inclusion criteria

  • Age >6 months
  • Distal penile hypospadias
  • Denovo hypospadias

Exclusion criteria

  • Recurrent hypospadias -Mid and proximal penile hypospadias

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06808139 · PRPgraft/DartosflapHypospadias

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗