Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP) (FGTIP-TIP)
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|ClinicalTrials.gov Identifier: NCT02497963|
Recruitment Status : Unknown
Verified July 2015 by Byron Pacheco Mendoza, Hospital Infantil de Mexico Federico Gomez.
Recruitment status was: Not yet recruiting
First Posted : July 15, 2015
Last Update Posted : July 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypospadias||Procedure: Foreskin Graft-Tubularized Incised Plate Procedure: Tubularized Incised Plate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||March 2017|
Experimental: Foreskin Graft-Tubularized Incised Plate
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
TIP Urethroplasty with foreskin graft in primary hypospadias
Active Comparator: 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 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497963
|Contact: Byron A Pacheco Mendoza, MD MsCemail@example.com|
|Study Chair:||Mario E Rendón Macías, MD MsC||CMNXXI, IMSS|
|Study Director:||Onofre Muñoz Hernández, MD MsC||Hospital Infantil de Mexico Federico Gomez|