Comparison Of Outcome Of Different Layers in Hypospadias... | NCT06275646

Studies
Comparison Of Outcome Of Different Layers in Hypospadias Surgery

NCT06275646

Sponsor

Children Hospital and Institute of Child Health, Lahore

Status

Completed

Last Update Posted

Feb 23, 2024Actual

Enrollment

220Actual

Phase

Not Applicable

Conditions

Hypospadias

Interventions

PRP layer
dartos flap

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Apr 1, 2023Actual

First Submitted Date

Feb 12, 2024

First Submission Date that Met QC Criteria

Feb 16, 2024

First Posted Date

Feb 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2024

Last Update Posted Date

Feb 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammad Adeel Ashiq, Principal Investigator, Children Hospital and Institute of Child Health, LahorePrincipal Investigator

Lead Sponsor

Children Hospital and Institute of Child Health, LahoreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A dartos flap and PRP layer	Experimental	dartos flap and PRP layer was applied in hypospadias surgery as additional layer	Other: PRP layer Other: dartos flap
preputial dartos flap layer	Experimental	preputial dartos flap layer applied as additional layer	Other: dartos flap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP layer	Other	platelet rich plasma layer was applied in addition to dartos flap	A dartos flap and PRP layer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

only males with hypospadias

Minimum Age

6 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Adeel Ashiq, M.S	CHUCHS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children Hospital		Lahore	Punjab Province	42000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007021	Hypospadias

Ancestor Terms

ID	Term
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided