Comparison Of Outcome Of Different Layers in Hypospadias Surgery

Not Applicable

Completed

• Conditions: Hypospadias
• Interventions: Other: dartos flap; Other: PRP layer

• Registration Number: NCT06275646
• Lead Sponsor: Children Hospital and Institute of Child Health, Lahore

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

Detailed Description

Objective To compare the outcome of application of autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery.

Methods This randomized controlled trial was conducted at Pediatric General surgical department, the Children's hospital and the University of Child health, Lahore for the period of 12 months. Non probability, purposive sampling was used for data collection and randomization was done to assign the treatment. Total of 220 patients fulfilling the selection criteria were admitted after taking an informed consent. Cases were randomly divided into two groups A and B using random generator of Excel program. In group-A, dartos flap and PRP sheet layer was applied and in group-B, only a preputial dartos fascial flap was applied.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-04-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 220

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preputial dartos flap layer	dartos flap	preputial dartos flap layer applied as additional layer
A dartos flap and PRP layer	PRP layer	dartos flap and PRP layer was applied in hypospadias surgery as additional layer
A dartos flap and PRP layer	dartos flap	dartos flap and PRP layer was applied in hypospadias surgery as additional layer

Primary Outcome Measures

Name	Time	Method
frequency of glans dehiscence	30 days	glans dehiscence observed
frequency of meatal stenosis	30 days	meatal stenosis assessed on examination
wound infectiom	30 days	local wound infection assessed by southampton wound assessment scale where 0 means excellent and 4 means worst

Trial Locations

Locations (1)

The Children Hospital; 🇵🇰 Lahore, Punjab, Pakistan