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

January 6, 2021 updated by: Malik Asad Munir, King Edward Medical University

To Compare the Frequency of Urethrocutaneous Fistula After Double Dartos Tubularized Incised Plate (TIP) Urethroplasty and Single Dartos Tubularized Incised

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 042
        • KEMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single Dartos TIP
Single dartos tubularized incised plate urethroplasty
Procedure: Group A
To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty
Other Names:
  • Single dartos TIP
EXPERIMENTAL: Double Dartos TIP
Double dartos tubularized incised plate urethroplasty
Procedure: Group B
To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty
Other Names:
  • Double dartos TIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of urethro-cutaneous fistula
Time Frame: 17 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Investigators

  • Principal Investigator: Asad Munir, FCPS, King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

January 31, 2018

Study Completion (ACTUAL)

January 31, 2018

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

January 6, 2021

First Posted (ACTUAL)

January 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEMU1234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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