Skip to main content
OpenTrials
Completed

NCT Number: NCT04699318

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

2 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

KEMU

Lahore, Punjab Province, 042, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Group B

Procedure

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

Other names: Double dartos TIP

Group A

Procedure

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

Other names: Single dartos TIP

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2021
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.