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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06275646
Enrollment
220
Registered
2024-02-23
Start date
2022-01-01
Completion date
2023-04-01
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Keywords

Hypospadias, platelet rich plasma, distal penile hypospadias

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.

Interventions

OTHERPRP layer

platelet rich plasma layer was applied in addition to dartos flap

dartos flap alone was used

Sponsors

Children Hospital and Institute of Child Health, Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized control trial

Eligibility

Sex/Gender
MALE
Age
6 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
wound infectiom30 dayslocal wound infection assessed by southampton wound assessment scale where 0 means excellent and 4 means worst
frequency of glans dehiscence30 daysglans dehiscence observed
frequency of meatal stenosis30 daysmeatal stenosis assessed on examination

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026