NCT06275646

Comparison Of Outcome Of Different Layers in Hypospadias Surgery

Comparison Of Outcome Of Autologus Platelet Rich Plasma Membrane Plus Dartos Flap Versus Simple Dartos Flap In Hypospadias Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Children Hospital and Institute of Child Health, Lahore · Academic / Other
• Sex: Male
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypospadias

Interventions

Type	Name	Description
OTHER	PRP layer	platelet rich plasma layer was applied in addition to dartos flap
OTHER	dartos flap	dartos flap alone was used

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-12-31
• Completion: 2023-04-01
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: Pakistan