Clinical trial NCT02497963: Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)
Official title: Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypospadias
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 68
Sex: MALE
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with complications as a measure of safety
timeFrame: Fourth month after surgery
Secondary outcomes:
measure: Proportion of participants with fistula as a measure of safety
timeFrame: Fourth month after surgery
measure: Proportion of participants with stricture as a measure of safety
timeFrame: Fourth month after surgery
measure: Proportion of participants with breakdown as a measure of safety
timeFrame: Fourth month after surgery
Other outcomes:
measure: Degree of Cosmetic by HOPE Score as a measure of efficacy
timeFrame: Fourth and sixth months after suregry
measure: Urinary mean flow by uroflowmeter as a measure of efficacy
timeFrame: Fourth and sixth months after surgery
Locations:
Study officials:
affiliation: CMNXXI, IMSS
name: Mario E Rendón Macías, MD MsC
role: STUDY_CHAIR
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Onofre Muñoz Hernández, MD MsC
role: STUDY_DIRECTOR
References:
citation: Snodgrass WT. Re: Effect of suturing technique and urethral plate characteristics on complication rate following hypospadias repair: a prospective randomized study O. Sarhan, M. Saad, T. Helmy and A. Hafez J Urol 2009; 182: 682-686. J Urol. 2010 Apr;183(4):1649-50; discussion 1650. doi: 10.1016/j.juro.2009.12.048. Epub 2010 Mar 4. No abstract available.
citation: Snodgrass W. Tubularized, incised plate urethroplasty for distal hypospadias. J Urol. 1994 Feb;151(2):464-5. doi: 10.1016/s0022-5347(17)34991-1.
citation: Kolon TF, Gonzales ET Jr. The dorsal inlay graft for hypospadias repair. J Urol. 2000 Jun;163(6):1941-3.
citation: Holland AJ, Smith GH. Effect of the depth and width of the urethral plate on tubularized incised plate urethroplasty. J Urol. 2000 Aug;164(2):489-91.
citation: Mouravas V, Filippopoulos A, Sfoungaris D. Urethral plate grafting improves the results of tubularized incised plate urethroplasty in primary hypospadias. J Pediatr Urol. 2014 Jun;10(3):463-8. doi: 10.1016/j.jpurol.2013.11.012. Epub 2013 Dec 10.