Hypospadias
Conditions
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.
Interventions
PROCEDUREForeskin Graft-Tubularized Incised Plate
TIP Urethroplasty with foreskin graft in primary hypospadias
PROCEDURETubularized Incised Plate
TIP Urethroplasty without foreskin graft in primary hypospadias
Sponsors
Hospital Infantil de Mexico Federico Gomez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
3 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with complications as a measure of safety | Fourth month after surgery |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Degree of Cosmetic by HOPE Score as a measure of efficacy | Fourth and sixth months after suregry |
| Urinary mean flow by uroflowmeter as a measure of efficacy | Fourth and sixth months after surgery |
Contacts
Primary ContactByron A Pacheco Mendoza, MD MsC
Outcome results
None listed