Hypospadias Clinical Trial
Official title:
Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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