Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Operation time.
研究概览
简要总结
Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate & good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.
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
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years(Child)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children age more than 12 months to 12 years.
- •De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)
排除标准
- •Circumcised
- •Ventral Penile curvature ≥30° after penile degloving & artificial erection, (requiring transection of urethral plate).
- •Uretheral plate less than 6mm
- •Megameatus intact prepuce
- •Albumin less than 3.5 g/dL
结局指标
主要结局
Operation time.
时间窗: intraoperative
the duration of the operation will be measured from the start of anesthesia to end.
site of the meatus
时间窗: 6 months from the operation
the meatal position will be measured in centimeters from the original position .
blood loss.
时间窗: one hour postoperatively
the amount of blood loss will be measured by CBC
次要结局
未报告次要终点
研究者
Abdelrahman Mohamed Abdelkader
teaching assistant of urology & andrology
Assiut University
