An interventional study of Foreskin Graft-Tubularized Incised Plate and Tubularized Incised Plate in Hypospadias, sponsored by Hospital Infantil de Mexico Federico Gomez. Status unknown. Open to male participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2015-07-15.
Sponsored by Hospital Infantil de Mexico Federico Gomez · Not applicable, Interventional, and Treatment
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.
131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's planned enrollment of 68 is close to the median of 68 across 102 interventional studies indexed under Hypospadias.
Browse Hypospadias studies →Hospital Infantil de Mexico Federico Gomez is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Foreskin Graft-Tubularized Incised Plate
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.
Procedure: Tubularized Incised Plate
TIP Urethroplasty with foreskin graft in primary hypospadias
TIP Urethroplasty without foreskin graft in primary hypospadias
Proportion of participants with complications as a measure of safety
Time frame: Fourth month after surgery
Proportion of participants with fistula as a measure of safety
Time frame: Fourth month after surgery
Proportion of participants with stricture as a measure of safety
Time frame: Fourth month after surgery
Proportion of participants with breakdown as a measure of safety
Time frame: Fourth month after surgery
Degree of Cosmetic by HOPE Score as a measure of efficacy
Time frame: Fourth and sixth months after suregry
Urinary mean flow by uroflowmeter as a measure of efficacy
Time frame: Fourth and sixth months after surgery
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Hospital Infantil de Mexico Federico Gomez