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

Hospital Infantil de Mexico Federico Gomez

Status: Unknown

Conditions: Hypospadias

Treatments: Procedure: Foreskin Graft-Tubularized Incised Plate; Procedure: Tubularized Incised Plate

Study type: Interventional

Funder types: Other

Identifiers

NCT02497963

HIM 2015-079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: Male

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Foreskin Graft-Tubularized Incised Plate

Experimental group

Description:

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.

Treatment:

Procedure: Foreskin Graft-Tubularized Incised Plate

Tubularized Incised Plate

Active Comparator group

Description:

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.

Treatment:

Procedure: Tubularized Incised Plate