Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Analgesic agent use
研究概览
简要总结
To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.
详细描述
Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in Shuang Ho hospital. For these patients underwent surgical treatment, some surgeons used gauze with Bosmin for hemostasis and analgesia after surgery, and other surgeons used Gelfoam. These choices were often determined by surgeon's personal preference according to their experiences. Shuang Ho hospital has top three quantity of hemorrhoidectomy in Taiwan. So, a randomized controlled trial is conducted to evaluate the difference between hemostatic agents use after anal surgery.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
- •Patients who undergo fistulectomy or fistulotomy are include.
排除标准
- •Emergency operation
- •Patients with colorectal cancer
- •Liver cirrhosis
- •Patients with coagulopathy
- •Patients with HIV infection
结局指标
主要结局
Analgesic agent use
时间窗: 0-7days
Daily consumption of oral analgesics from post-operative day 0 to day 7
Post-operative pain
时间窗: 0-7 days
Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.
次要结局
- Incidence of post-operative bleeding(0-30 days)
- Incidence of surgical site infection(0-30 days)
- Incidence of urinary retention(0-7 days)
研究者
Tungcheng Chang, MD, PhD
Chief of Colorectal Surgery
Taipei Medical University Shuang Ho Hospital