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Trial record 35 of 117 for:    "Penile Disease"

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

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ClinicalTrials.gov Identifier: NCT02497963
Recruitment Status : Unknown
Verified July 2015 by Byron Pacheco Mendoza, Hospital Infantil de Mexico Federico Gomez.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Byron Pacheco Mendoza, Hospital Infantil de Mexico Federico Gomez

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE July 15, 2015
Last Update Posted Date July 15, 2015
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
Proportion of participants with complications as a measure of safety [ Time Frame: Fourth month after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • Proportion of participants with fistula as a measure of safety [ Time Frame: Fourth month after surgery ]
  • Proportion of participants with stricture as a measure of safety [ Time Frame: Fourth month after surgery ]
  • Proportion of participants with breakdown as a measure of safety [ Time Frame: Fourth month after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 14, 2015)
  • Degree of Cosmetic by HOPE Score as a measure of efficacy [ Time Frame: Fourth and sixth months after suregry ]
  • Urinary mean flow by uroflowmeter as a measure of efficacy [ Time Frame: Fourth and sixth months after surgery ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)
Official Title  ICMJE Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypospadias
Intervention  ICMJE
  • Procedure: Foreskin Graft-Tubularized Incised Plate
    TIP Urethroplasty with foreskin graft in primary hypospadias
  • Procedure: Tubularized Incised Plate
    TIP Urethroplasty without foreskin graft in primary hypospadias
Study Arms  ICMJE
  • Experimental: Foreskin Graft-Tubularized Incised Plate
    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.
    Intervention: Procedure: Foreskin Graft-Tubularized Incised Plate
  • Active Comparator: Tubularized Incised Plate
    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: Procedure: Tubularized Incised Plate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 3 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02497963
Other Study ID Numbers  ICMJE HIM 2015-079
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Byron Pacheco Mendoza, Hospital Infantil de Mexico Federico Gomez
Study Sponsor  ICMJE Hospital Infantil de Mexico Federico Gomez
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mario E Rendón Macías, MD MsC CMNXXI, IMSS
Study Director: Onofre Muñoz Hernández, MD MsC Hospital Infantil de Mexico Federico Gomez
PRS Account Hospital Infantil de Mexico Federico Gomez
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP