Back to resultsUrethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty
Primary Purpose
Hypospadias
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group B
Group A
Sponsored by
About this trial
This is an interventional treatment trial for Hypospadias
Eligibility 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
-
Sites / Locations
- KEMU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single Dartos TIP
Double Dartos TIP
Arm Description
Single dartos tubularized incised plate urethroplasty
Double dartos tubularized incised plate urethroplasty
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04699318
First Posted
November 5, 2018
Last Updated
January 6, 2021
Sponsor
King Edward Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04699318
Brief Title
Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty
Official Title
To Compare the Frequency of Urethrocutaneous Fistula After Double Dartos Tubularized Incised Plate (TIP) Urethroplasty and Single Dartos Tubularized Incised
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Dartos TIP
Arm Type
Experimental
Arm Description
Single dartos tubularized incised plate urethroplasty
Arm Title
Double Dartos TIP
Arm Type
Experimental
Arm Description
Double dartos tubularized incised plate urethroplasty
Intervention Type
Procedure
Intervention Name(s)
Group B
Other Intervention Name(s)
Double dartos TIP
Intervention Description
To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty
Intervention Type
Procedure
Intervention Name(s)
Group A
Other Intervention Name(s)
Single dartos TIP
Intervention Description
To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty
Primary Outcome Measure Information:
Title
Recurrence of urethro-cutaneous fistula
Description
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.
Time Frame
17 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male gender
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asad Munir, FCPS
Organizational Affiliation
King Edward Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KEMU
City
Lahore
State/Province
Punjab
ZIP/Postal Code
042
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty
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