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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04699318
Enrollment
60
Registered
2021-01-07
Start date
2017-08-01
Completion date
2018-01-31
Last updated
2021-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

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.

Interventions

PROCEDUREGroup B

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

PROCEDUREGroup A

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

Sponsors

King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
2 Years to 17 Years
Healthy volunteers
Yes

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of urethro-cutaneous fistula17 daysAbnormal communication between urethra and penile skin after urethroplasty, presenting with complaints of two streams of micturition and noted on examination at 17th postoperative day.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026