Comparison Of Outcome Of Different Layers in Hypospadias Surgery

Children Hospital and Institute of Child Health, Lahore

Status: Completed

Conditions: Hypospadias

Treatments: Other: dartos flap; Other: PRP layer

Study type: Interventional

Funder types: Other

Identifiers

NCT06275646

Adeel2

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: Male

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

A dartos flap and PRP layer

Experimental group

Description:

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

Treatment:

Other: dartos flap

Other: PRP layer

preputial dartos flap layer

Experimental group

Description:

preputial dartos flap layer applied as additional layer

Treatment:

Other: dartos flap