Urethrocutaneous Fistula Rate After Double Dartos and Sin... | NCT04699318

Studies
Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty

NCT04699318

Sponsor

King Edward Medical University

Status

Completed

Last Update Posted

Jan 7, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hypospadias

Interventions

Group B
Group A

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

Jan 2021

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

Aug 1, 2017Actual

Primary Completion Date

Jan 31, 2018Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

Nov 5, 2018

First Submission Date that Met QC Criteria

Jan 6, 2021

First Posted Date

Jan 7, 2021Actual

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

Jan 6, 2021

Last Update Posted Date

Jan 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The subjects were divided into two groups. Each group comprised 30 children. Children were randomly allocated in two groups via computer generated tables. Children in group-A underwent single dartos tubularized incised plate urethroplasty while those in group-B underwent double dartos tubularized incised plate urethroplasty.

Detailed Description

In group A dartos flap is raised from foreskin of the patient and applied as a single layer after tubularization in between neourethra and skin . In group B dartos flap is raised from the foreskin of patient and divided in two equal halves.Both flaps are placed as two layers in between skin and neourethra.After surgery patient is kept in ward for 10 days with stent.Patient is followed up in OPD on after 7th day after discharge for outcome.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Dartos TIP	Experimental	Single dartos tubularized incised plate urethroplasty	Procedure: Group A
Double Dartos TIP	Experimental	Double dartos tubularized incised plate urethroplasty	Procedure: Group B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group B	Procedure	To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty	Double Dartos TIP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of urethro-cutaneous fistula	Abnormal communication between urethra and penile skin after urethroplasty, presenting with complaints of two streams of micturition and noted on examination at 17th postoperative day.	17 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria All the patients above one year of age All patients having distal and mid penile hypospadias. -

Exclusion Criteria Severe chordee Previously operated cases Patient with undescended testis Circumcised patient

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male gender

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asad Munir, FCPS	King Edward Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KEMU		Lahore	Punjab Province	042	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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