Comparison Of Outcome Of Different Layers in Hypospadias Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-04-01

Brief Summary

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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

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Detailed Description

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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

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A dartos flap and PRP layer

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

Group Type EXPERIMENTAL

PRP layer

Intervention Type OTHER

platelet rich plasma layer was applied in addition to dartos flap

dartos flap

Intervention Type OTHER

dartos flap alone was used

preputial dartos flap layer

preputial dartos flap layer applied as additional layer

Group Type EXPERIMENTAL

dartos flap

Intervention Type OTHER

dartos flap alone was used

Interventions

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PRP layer

platelet rich plasma layer was applied in addition to dartos flap

Intervention Type OTHER

dartos flap

dartos flap alone was used

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No