Comparison Of Outcome Of Different Layers in Hypospadias Surgery

NCT06275646 | Completed DMC

• 1 other identifier: Adeel2
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied

Conditions

Hypospadias

Keywords

Hypospadias; platelet rich plasma; distal penile hypospadias

Outcome Measures

Primary Outcomes (3)

• wound infectiom

  local wound infection assessed by southampton wound assessment scale where 0 means excellent and 4 means worst

  30 days

• frequency of glans dehiscence

  glans dehiscence observed

  30 days

• frequency of meatal stenosis

  meatal stenosis assessed on examination

  30 days

Study Arms (2)

A dartos flap and PRP layer

EXPERIMENTAL

dartos flap and PRP layer was applied in hypospadias surgery as additional layer

Other: PRP layer; Other: dartos flap

preputial dartos flap layer

EXPERIMENTAL

preputial dartos flap layer applied as additional layer

Other: dartos flap

Interventions

PRP layer OTHER

platelet rich plasma layer was applied in addition to dartos flap

A dartos flap and PRP layer

dartos flap OTHER

dartos flap alone was used

A dartos flap and PRP layer; preputial dartos flap layer

Eligibility Criteria

• Age: 6 Months - 12 Years
• Gender Eligibility Details: only males with hypospadias
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients (Age 6months to12 years) with mid, distal penile or sub coronal hypospadias having minimal chordae were included in the study

You may not qualify if:

• Patients having proximal hypospadias, moderate to severe chordae, previously operated cases, a preoperative androgens treatment (for example in penoscrotal hypospadias and small sized phallus) were excluded from study

Sponsors & Collaborators

• Children Hospital and Institute of Child Health, Lahore: lead

Study Sites (1)

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Adeel Ashiq, M.S

  CHUCHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized control trial

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 23, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: April 1, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)