The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.
详细描述
For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.
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 underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
- •Patients who underwent fistulotomy or fistulectomy
排除标准
- •Emergency surgery
- •Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery
- •Complicated fistulectomy, e.g., requiring surgical drainage and seton placement
- •Other types of anal surgery, e.g., anal fissure and colorectal cancer
- •Liver cirrhosis
- •Coagulation dysfunction
- •Bedridden
- •Human immunodeficiency virus infection
结局指标
主要结局
Pain score
时间窗: On postoperative day 0 to day 7
record max pain score(visual analog scale:0-10) each day
Consumption of analgesics
时间窗: On postoperative day 0 to day 7
daily consumption of oral analgesics from post-operative day 0 to day 7
次要结局
- First defecation after surgery(On postoperative day 0 to day 7)
- Incidence of surgical site infection(On postoperative day 0-30)
- Incidence of Urinary retention(On postoperative day 0 to day 7)
研究者
Tungcheng Chang, MD, PhD
Chief of Colorectal Surgery
Taipei Medical University Shuang Ho Hospital