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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.


Clinical Trial 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. ;


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


NCT number NCT02497963
Study type Interventional
Source Hospital Infantil de Mexico Federico Gomez
Contact Byron A Pacheco Mendoza, MD MsC
Phone +525544378709
Email byronpachecom@yahoo.com
Status Not yet recruiting
Phase N/A
Start date August 2015
Completion date March 2017

See also
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Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
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Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A