Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 610
- 试验地点
- 10
- 主要终点
- Incidence of POI
研究概览
简要总结
Postoperative intestinal obstruction (POI) is one of the most common complications in the gastrointestinal surgery. Compared with the conventional control group, transcutaneous acupoint electrical stimulation(TEAS) is possible to reduce the incidence of POI and accelerate the rapid recovery of the gastrointestinal tract.
详细描述
Participants will be randomly assigned, in a 1:1 ratio, to receive TEAS or Blank treatment (acupoints selection are same with the experimental group, connect stimulator for patients, but not don't give stimulus). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. TEAS will be performed in a series of time periods after operation. Time of first fart and food-taking ,time of have normal diet after the transplantation will be recorded. The participation of each patient is scheduled for 30 days.
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)
盲法说明
Randomised Controlled Trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients signed the informed consent before treatment;
- •Age ≥ 18 years old,American society of Anesthesiologists(ASA)grade are between I and III;
- •Plan to perform elective colon and rectal tumor resection under general anesthesia;
- •not involved in other clinical studies;
- •no cognitive impairment, mental disorders,communication disorders.
排除标准
- •Pregnancy, breast-feeding;
- •The history of intestinal surgery;
- •Test point skin injury, infection, allergies to tape;
- •have undergone external enterostomy;
- •Chief surgeon refuse to cooperate.
结局指标
主要结局
Incidence of POI
时间窗: 72 hours after surgery
Whether or not to exhaust in 72 hours after surgery
次要结局
- recovery of bowel sounds(1-3 days after surgery)
- recovery index(once a week for 30 days after surgery)
- adverse reactions of digestive after surgery(1-3 days after surgery)
- postoperative gastrointestinal function recovery(once a week for 30 days after surgery)
- surgery complications(once a week for 30 days after surgery)