The Effect of Acupoint Application on Postoperative Ileus: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- time to defecate and tolerate for food (TF+D)
研究概览
简要总结
This study aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.
详细描述
Postoperative ileus (POI) is a common disorder of gastrointestinal motility characterized by abdominal distension, nausea, vomiting and delayed passage of flatus or stool, which develops after every abdominal surgical procedure. POI increases risk of developing postoperative complications, decreases the bed turnover rate and prolongs the average duration of hospitalization, increasing the expense of both patients and hospitals. Although the Pathophysiological mechanism of POI remains unclear, recent researches suggests the inflammatory responses after surgery might be responsible for the gastrointestinal motility disorder. Acupoint application is a traditional chinese intervention which has been used in treating gastrointestinal motility disorder resulted from other causes. In this study, we aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are scheduled to undergo elective abdominal surgery;
- •Patients age between 20 to 80 years old;
- •Umbilical skin condition is good;
- •Written informed consent provided to participate in the study.
排除标准
- •1.Patients don't match the inclusion criteria;
- •Patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ;
- •3.Patients with mental disorder;
- •Patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc;
- •Patients received ostomy operation, such as jejunostomy;
- •6.Patients who have history of abdominal surgery or history of bowel obstruction;
- •Patients who receive other treatments to improve the gastrointestinal mobility or/and to relieve POI related symptoms , such as gastrointestinal prokinetic drugs, enema, etc.
- •Patients who are allergic to the acupoint applicaton;
- •9.Patients who are unsuitable for study inclusion as determined by the investigator. (eg: patients with severe operation related complications)
研究组 & 干预措施
Intervention arm
Receiving the acupoint application and optimal supports.
The patients start using the acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc.
干预措施: Acupoint application (Other)
Placebo arm
Receiving the fake acupoint application and optimal supports.
The fake acupoint is
The patients start using the fake acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc.
干预措施: Fake acupoint application (Other)
Control arm
Receiving the optimal supports.
All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc.
结局指标
主要结局
time to defecate and tolerate for food (TF+D)
时间窗: End of surgery to time to defecate and tolerate for food(from 5 to 7 days)
Defined as the first time that the patient could both defecate and tolerate orally taking food after surgery.
次要结局
- time to report of first flatus(End of surgery to the first flatus (from 1 to 5 days))
- time to report of first defecation(End of surgery to the first defecation. (from 1 to 7 days))
- length of postoperative hospitalization(End of surgery to hospital discharge. (from 5 to 7 days))
- time to return of bowel sounds(End of surgery to the first bowel sound (from 1 to 5 days))
研究者
li xiong
Professor
Central South University