Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes. A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- bipolar diathermy use
研究概览
简要总结
Although haemostasis aimed to maintain bloodless surgical field for better exposure for the surgeon, cosmetic impact, and decreased breakdown of repair, there is no trials regarding the impact of haemostasis techniques on surgeon satisfaction during surgery and patients reported outcomes.
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
- 6 Months 至 36 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair
排除标准
- •coagulopathy
- •sickle cell disease or sickle cell trait
- •circumcised patient
- •history of previous failed surgery
- •severe chordee (>30 degree after degloving).
研究组 & 干预措施
Tourniquet
tubularized incided plate (TIP) urethroplasty plus tourniquet
干预措施: Tourniquet (Procedure)
Non-tourniquet
tubularized incided plate (TIP) urethroplasty plus non-tourniquet
干预措施: Non-tourniquet (Procedure)
结局指标
主要结局
bipolar diathermy use
时间窗: 12 months
by number of bipolar diathermy usage
assess Intraoperative blood loss
时间窗: 12 months
by blood loss in milliliter in used gauze piece
Surgeon satisfaction about haemostasis
时间窗: 12 months
Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).
次要结局
- Patient-reported satisfaction(24 months)
- Long term complication rate(60 months)