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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foreskin Graft-Tubularized Incised Plate | Experimental | 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. |
|
| Tubularized Incised Plate | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foreskin Graft-Tubularized Incised Plate | Procedure | TIP Urethroplasty with foreskin graft in primary hypospadias |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with complications as a measure of safety | Fourth month after surgery |
| Measure | Description | 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 | |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byron A Pacheco Mendoza, MD MsC | Contact | +525544378709 | byronpachecom@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mario E Rendón MacÃas, MD MsC | CMNXXI, IMSS | Study Chair |
| Onofre Muñoz Hernández, MD MsC | Hospital Infantil de Mexico Federico Gomez | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20206364 | Background | 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. | |
| 8283561 |
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Tubularized Incised Plate | Procedure | TIP Urethroplasty without foreskin graft in primary hypospadias |
|
| Proportion of participants with breakdown as a measure of safety |
| Fourth month after surgery |
| 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. |
| 10799234 | Result | Kolon TF, Gonzales ET Jr. The dorsal inlay graft for hypospadias repair. J Urol. 2000 Jun;163(6):1941-3. |
| 10893631 | Result | 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. |
| 24360521 | Result | 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. |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |