Comparison Of Outcome Of Different Layers in Hypospadias Surgery

Hypospadias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06275646
• Other study ID #: Adeel2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2024
• Source: Children Hospital and Institute of Child Health, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypospadias

Intervention

Other:
• PRP layer
platelet rich plasma layer was applied in addition to dartos flap
• dartos flap
dartos flap alone was used

Locations

Country	Name	City	State
Pakistan	The Children Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Children Hospital and Institute of Child Health, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound infectiom	local wound infection assessed by southampton wound assessment scale where 0 means excellent and 4 means worst	30 days
Primary	frequency of glans dehiscence	glans dehiscence observed	30 days
Primary	frequency of meatal stenosis	meatal stenosis assessed on examination	30 days