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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)

Conditions
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Hypospadias

Intervention / Treatment
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* Procedure: Foreskin Graft-Tubularized Incised Plate
* Procedure: Tubularized Incised Plate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foreskin Graft-Tubularized Incised Plate<br>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<br>* TIP Urethroplasty with foreskin graft in primary hypospadias<br>|
| Active Comparator: Tubularized Incised Plate<br>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<br>* TIP Urethroplasty without foreskin graft in primary hypospadias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with complications as a measure of safety |  | Fourth month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with fistula as a measure of safety |  | Fourth month after surgery | 
| Proportion of participants with stricture as a measure of safety |  | Fourth month after surgery | 
| Proportion of participants with breakdown as a measure of safety |  | Fourth month after surgery |