NCT02497963

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Hospital Infantil de Mexico Federico Gomez · Academic / Other
• Sex: Male
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypospadias

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2015-07-15
• Last updated: 2015-07-15