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Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP) (FGTIP-TIP)

Primary Purpose

Hypospadias

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Foreskin Graft-Tubularized Incised Plate
Tubularized Incised Plate
Sponsored by
Hospital Infantil de Mexico Federico Gomez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypospadias

Eligibility Criteria

3 Months - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with hypospadias without previous surgery
  • Hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

Exclusion Criteria:

  • Patients diagnosed with hypospadias and severe psychomotor development delay
  • Patients with disorders of sexual development without gender assignment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Foreskin Graft-Tubularized Incised Plate

    Tubularized Incised Plate

    Arm Description

    Group of patients with primary hypospadias undergoing Foreskin Graft Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, graft inner foreskin, and create a new urethra on a urethral catheter.

    Group of patients with primary hypospadias undergoing Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, and create a new urethra on a urethral catheter.

    Outcomes

    Primary Outcome Measures

    Proportion of participants with complications as a measure of safety

    Secondary Outcome Measures

    Proportion of participants with fistula as a measure of safety
    Proportion of participants with stricture as a measure of safety
    Proportion of participants with breakdown as a measure of safety

    Full Information

    First Posted
    June 25, 2015
    Last Updated
    July 14, 2015
    Sponsor
    Hospital Infantil de Mexico Federico Gomez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02497963
    Brief Title
    Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)
    Acronym
    FGTIP-TIP
    Official Title
    Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Infantil de Mexico Federico Gomez

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.
    Detailed Description
    Urethroplasty technique more used in the world for hypospadias repair is Tubularized Incised Plate described by Snodgrass in 1994. Kolon and Gonzales described a technical modification to the TIP in 2000, which is called grafting foreskin. There are characteristics of the glans and urethral plate favoring the development of complications. In this study the researchers include patients with primary hypospadias, with these characteristics above, and compare two surgical techniques: TIP vs FG-TIP. The main aim is to determine the efficacy (functional and cosmetic) and safety (complications) of TIP vs FG-TIP. The study design is a randomized clinical trial, double blind (patient and evaluator), parallel groups. The sample size was calculated comparing two proportions, with a alpha 0.05, beta 0.2; 34 patients per group. The main outcome is complications.

    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
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Foreskin Graft-Tubularized Incised Plate
    Arm Type
    Experimental
    Arm Description
    Group of patients with primary hypospadias undergoing Foreskin Graft Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, graft inner foreskin, and create a new urethra on a urethral catheter.
    Arm Title
    Tubularized Incised Plate
    Arm Type
    Active Comparator
    Arm Description
    Group of patients with primary hypospadias undergoing Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, and create a new urethra on a urethral catheter.
    Intervention Type
    Procedure
    Intervention Name(s)
    Foreskin Graft-Tubularized Incised Plate
    Intervention Description
    TIP Urethroplasty with foreskin graft in primary hypospadias
    Intervention Type
    Procedure
    Intervention Name(s)
    Tubularized Incised Plate
    Intervention Description
    TIP Urethroplasty without foreskin graft in primary hypospadias
    Primary Outcome Measure Information:
    Title
    Proportion of participants with complications as a measure of safety
    Time Frame
    Fourth month after surgery
    Secondary Outcome Measure Information:
    Title
    Proportion of participants with fistula as a measure of safety
    Time Frame
    Fourth month after surgery
    Title
    Proportion of participants with stricture as a measure of safety
    Time Frame
    Fourth month after surgery
    Title
    Proportion of participants with breakdown as a measure of safety
    Time Frame
    Fourth month after surgery
    Other Pre-specified Outcome Measures:
    Title
    Degree of Cosmetic by HOPE Score as a measure of efficacy
    Time Frame
    Fourth and sixth months after suregry
    Title
    Urinary mean flow by uroflowmeter as a measure of efficacy
    Time Frame
    Fourth and sixth months after surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with hypospadias without previous surgery Hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate. Exclusion Criteria: Patients diagnosed with hypospadias and severe psychomotor development delay Patients with disorders of sexual development without gender assignment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Byron A Pacheco Mendoza, MD MsC
    Phone
    +525544378709
    Email
    byronpachecom@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mario E Rendón Macías, MD MsC
    Organizational Affiliation
    CMNXXI, IMSS
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Onofre Muñoz Hernández, MD MsC
    Organizational Affiliation
    Hospital Infantil de Mexico Federico Gomez
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20206364
    Citation
    Snodgrass WT. Re: Effect of suturing technique and urethral plate characteristics on complication rate following hypospadias repair: a prospective randomized study O. Sarhan, M. Saad, T. Helmy and A. Hafez J Urol 2009; 182: 682-686. J Urol. 2010 Apr;183(4):1649-50; discussion 1650. doi: 10.1016/j.juro.2009.12.048. Epub 2010 Mar 4. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8283561
    Citation
    Snodgrass W. Tubularized, incised plate urethroplasty for distal hypospadias. J Urol. 1994 Feb;151(2):464-5. doi: 10.1016/s0022-5347(17)34991-1.
    Results Reference
    result
    PubMed Identifier
    10799234
    Citation
    Kolon TF, Gonzales ET Jr. The dorsal inlay graft for hypospadias repair. J Urol. 2000 Jun;163(6):1941-3.
    Results Reference
    result
    PubMed Identifier
    10893631
    Citation
    Holland AJ, Smith GH. Effect of the depth and width of the urethral plate on tubularized incised plate urethroplasty. J Urol. 2000 Aug;164(2):489-91.
    Results Reference
    result
    PubMed Identifier
    24360521
    Citation
    Mouravas V, Filippopoulos A, Sfoungaris D. Urethral plate grafting improves the results of tubularized incised plate urethroplasty in primary hypospadias. J Pediatr Urol. 2014 Jun;10(3):463-8. doi: 10.1016/j.jpurol.2013.11.012. Epub 2013 Dec 10.
    Results Reference
    result

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    Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)

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