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NCT Number: NCT06808139

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

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

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Key information

Conditions

Penile Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

6 month and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Recurrent hypospadias -Mid and proximal penile hypospadias

Treatment and study plan

Plasma-Rich Platelet Graft

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

Dartos Flap

Procedure

preputial dartos flap will be used

Primary outcomes

  1. incidence of occurrence of uretherocutanous fistula

    Time frame: 6 month

    occurrence of conection between urthera and skin

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed ali amen diab, residant doctor

CONTACT

[email protected]

+201023222678

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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