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

Not Applicable

Completed

• Conditions: Hypospadias
• Interventions: Procedure: Group B; Procedure: Group A

• Registration Number: NCT04699318
• Lead Sponsor: King Edward Medical University

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.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Study First Submitted: 2018-11-05
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-06
• Last Update Submitted: 2021-01-06
• Study First Posted: 2021-01-07
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Dartos TIP	Group B	Double dartos tubularized incised plate urethroplasty
Single Dartos TIP	Group A	Single dartos tubularized incised plate urethroplasty

Primary Outcome Measures

Name	Time	Method
Recurrence of urethro-cutaneous fistula	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.

Trial Locations

Locations (1)

KEMU; 🇵🇰 Lahore, Punjab, Pakistan