NCT04699318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

November 5, 2018

Last Update Submit

January 6, 2021

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Single Dartos TIP

EXPERIMENTAL

Single dartos tubularized incised plate urethroplasty

Procedure: Group A

Double Dartos TIP

EXPERIMENTAL

Double dartos tubularized incised plate urethroplasty

Procedure: Group B

Interventions

Group BPROCEDURE

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

Also known as: Double dartos TIP
Double Dartos TIP
Group APROCEDURE

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

Also known as: Single dartos TIP
Single Dartos TIP

Eligibility Criteria

Age2 Years - 17 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale gender
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMU

Lahore, Punjab Province, 042, Pakistan

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Asad Munir, FCPS

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Malik ASAD Munir

Study Record Dates

First Submitted

November 5, 2018

First Posted

January 7, 2021

Study Start

August 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations

PA(1)