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

King Edward Medical University

Status: Completed

Conditions: Hypospadias

Treatments: Procedure: Group A; Procedure: Group B

Study type: Interventional

Funder types: Other

Identifiers

NCT04699318

KEMU1234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Single Dartos TIP

Experimental group

Description:

Single dartos tubularized incised plate urethroplasty

Treatment:

Procedure: Group A

Double Dartos TIP

Experimental group

Description:

Double dartos tubularized incised plate urethroplasty

Treatment:

Procedure: Group B