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NCT04699318 Clinical Trial

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

Hypospadias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04699318
Other study ID # KEMU1234
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date January 31, 2018

Study information
Verified date January 2021
Source King Edward Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 2 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Group B
To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty
• Group A
To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty

Locations
Country Name City State
Pakistan KEMU Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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