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

NCT ID: NCT04699318

Last Updated: 2021-01-07

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Dartos TIP

Single dartos tubularized incised plate urethroplasty

Group Type EXPERIMENTAL

Group A

Intervention Type PROCEDURE

To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty

Double Dartos TIP

Double dartos tubularized incised plate urethroplasty

Group Type EXPERIMENTAL

Group B

Intervention Type PROCEDURE

To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty

Interventions

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Group B

To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty

Intervention Type PROCEDURE

Group A

To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty

Intervention Type PROCEDURE

Other Intervention Names

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Double dartos TIP Single dartos TIP

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Malik Asad Munir

Malik ASAD Munir

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asad Munir, FCPS

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University

Locations

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KEMU

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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KEMU1234

Identifier Type: -

Identifier Source: org_study_id

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