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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

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.

Condition or disease Intervention/treatment Phase
Hypospadias Procedure: Foreskin Graft-Tubularized Incised Plate Procedure: Tubularized Incised Plate Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
Study Start Date : August 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
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.
Procedure: Foreskin Graft-Tubularized Incised Plate
TIP Urethroplasty with foreskin graft in primary hypospadias

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.
Procedure: Tubularized Incised Plate
TIP Urethroplasty without foreskin graft in primary hypospadias




Primary Outcome Measures :
  1. Proportion of participants with complications as a measure of safety [ Time Frame: Fourth month after surgery ]

Secondary Outcome Measures :
  1. Proportion of participants with fistula as a measure of safety [ Time Frame: Fourth month after surgery ]
  2. Proportion of participants with stricture as a measure of safety [ Time Frame: Fourth month after surgery ]
  3. Proportion of participants with breakdown as a measure of safety [ Time Frame: Fourth month after surgery ]

Other Outcome Measures:
  1. Degree of Cosmetic by HOPE Score as a measure of efficacy [ Time Frame: Fourth and sixth months after suregry ]
  2. Urinary mean flow by uroflowmeter as a measure of efficacy [ Time Frame: Fourth and sixth months after surgery ]


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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497963


Contacts
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Contact: Byron A Pacheco Mendoza, MD MsC +525544378709 byronpachecom@yahoo.com

Sponsors and Collaborators
Hospital Infantil de Mexico Federico Gomez
Investigators
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Study Chair: Mario E Rendón Macías, MD MsC CMNXXI, IMSS
Study Director: Onofre Muñoz Hernández, MD MsC Hospital Infantil de Mexico Federico Gomez

Publications of Results:
Other Publications:
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Responsible Party: Byron Pacheco Mendoza, MD, MsC, Pediatric Urologist,, Hospital Infantil de Mexico Federico Gomez
ClinicalTrials.gov Identifier: NCT02497963     History of Changes
Other Study ID Numbers: HIM 2015-079
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities