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

Not Applicable

• Conditions: Hypospadias
• Interventions: Procedure: Foreskin Graft-Tubularized Incised Plate; Procedure: Tubularized Incised Plate

• Registration Number: NCT02497963
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-06-25
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15
• Study Start: 2015-08
• Primary Completion: 2017-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foreskin Graft-Tubularized Incised Plate	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.
Tubularized Incised Plate	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with complications as a measure of safety	Fourth month after surgery

Secondary Outcome Measures

Name	Time	Method
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