NCT02353156Unknown2 期
Single Blind, Randomized Controlled, Multicenter Study to Evaluate the Efficacy and Convenience of Electronic Bidet With Very Low Force Flow Fountain System for Pain Control and Wound Healing After Operation for Anal Disease, Compared to Conventional Sitz Bath
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 76
- 主要终点
- pain score
研究概览
简要总结
The investigator will perform a randomized clinical trials to compare the effect of pain management and wound healing after hemorrhoidectomy between warm sitz bath and electronic bidet.
详细描述
After hemorrhoidectomy, the patients should take warm sitz bath for relieving pain and inducing wound healing. Electronic bidet is a device for cleansing the anus after defecation, and some patients are using the bidet for sitz bath. Thus, the investigator perform this study for comparing the effect of pain and wound management after hemorrhoidectomy between sitz bath and electronic bidet
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients who undergo hemorrhoidectomy
排除标准
- •previous history of anal surgery
- •Crohn's anal disease
- •perianal complex abscess or fistula
- •uncontrollable medical disease
- •malignancy
- •immunocompromised
- •pregnancy
- •breast feeding
- •NSAID allergy
结局指标
主要结局
pain score
时间窗: 1 week
visual analog scale after hemorrhoidectomy at 1 week
次要结局
- wound healing(4 week)
- convenience(4 week)
- urinary difficulty(4 week)
研究者
Kyu Joo Park
Professor
Seoul National University Hospital
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