Comparison Of Outcome Of Autologus Platelet Rich Plasma Membrane Plus Dartos Flap Versus Simple Dartos Flap In Hypospadias Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- frequency of glans dehiscence
研究概览
简要总结
To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied
详细描述
Objective To compare the outcome of application of autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery.
Methods This randomized controlled trial was conducted at Pediatric General surgical department, the Children's hospital and the University of Child health, Lahore for the period of 12 months. Non probability, purposive sampling was used for data collection and randomization was done to assign the treatment. Total of 220 patients fulfilling the selection criteria were admitted after taking an informed consent. Cases were randomly divided into two groups A and B using random generator of Excel program. In group-A, dartos flap and PRP sheet layer was applied and in group-B, only a preputial dartos fascial flap was applied.
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
- 6 Months 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients (Age 6months to12 years) with mid, distal penile or sub coronal hypospadias having minimal chordae were included in the study
排除标准
- •Patients having proximal hypospadias, moderate to severe chordae, previously operated cases, a preoperative androgens treatment (for example in penoscrotal hypospadias and small sized phallus) were excluded from study
研究组 & 干预措施
A dartos flap and PRP layer
dartos flap and PRP layer was applied in hypospadias surgery as additional layer
干预措施: PRP layer (Other)
A dartos flap and PRP layer
dartos flap and PRP layer was applied in hypospadias surgery as additional layer
干预措施: dartos flap (Other)
preputial dartos flap layer
preputial dartos flap layer applied as additional layer
干预措施: dartos flap (Other)
结局指标
主要结局
frequency of glans dehiscence
时间窗: 30 days
glans dehiscence observed
frequency of meatal stenosis
时间窗: 30 days
meatal stenosis assessed on examination
wound infectiom
时间窗: 30 days
local wound infection assessed by southampton wound assessment scale where 0 means excellent and 4 means worst
次要结局
未报告次要终点
研究者
Muhammad Adeel Ashiq
Principal Investigator
Children Hospital and Institute of Child Health, Lahore