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

Hypospadias Clinical Trial

— FGTIP-TIP  

Official title:

Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02497963
• Other study ID #: HIM 2015-079
• Status: Not yet recruiting
• Phase: N/A
• First received: June 25, 2015
• Last updated: July 14, 2015
• Start date: August 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2015
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: Byron A Pacheco Mendoza, MD MsC
• Phone: +525544378709
• Email: byronpachecom[@]yahoo.com
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Months to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypospadias

Intervention

Procedure:
• Foreskin Graft-Tubularized Incised Plate
TIP Urethroplasty with foreskin graft in primary hypospadias
• Tubularized Incised Plate
TIP Urethroplasty without foreskin graft in primary hypospadias

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

References & Publications (5)

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. — View Citation

Kolon TF, Gonzales ET Jr. The dorsal inlay graft for hypospadias repair. J Urol. 2000 Jun;163(6):1941-3. — View 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. — View Citation

Snodgrass W. Tubularized, incised plate urethroplasty for distal hypospadias. J Urol. 1994 Feb;151(2):464-5. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree of Cosmetic by HOPE Score as a measure of efficacy		Fourth and sixth months after suregry	No
Other	Urinary mean flow by uroflowmeter as a measure of efficacy		Fourth and sixth months after surgery	No
Primary	Proportion of participants with complications as a measure of safety		Fourth month after surgery	Yes
Secondary	Proportion of participants with fistula as a measure of safety		Fourth month after surgery	Yes
Secondary	Proportion of participants with stricture as a measure of safety		Fourth month after surgery	Yes
Secondary	Proportion of participants with breakdown as a measure of safety		Fourth month after surgery	Yes