Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 主要终点
- Proportion of participants with complications as a measure of safety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients diagnosed with hypospadias and severe psychomotor development delay
- •Patients with disorders of sexual development without gender assignment
结局指标
主要结局
Proportion of participants with complications as a measure of safety
时间窗: Fourth month after surgery
次要结局
- 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)
- Proportion of participants with breakdown as a measure of safety(Fourth month after surgery)
研究者
Byron Pacheco Mendoza
MD, MsC, Pediatric Urologist,
Hospital Infantil de Mexico Federico Gomez