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
About this trial
This is an interventional treatment trial for Hypospadias
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
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
NCT ID
NCT02497963
First Posted
June 25, 2015
Last Updated
July 14, 2015
Sponsor
Hospital Infantil de Mexico Federico Gomez
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
Learn more about this trial
Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)
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