Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Remnant sitz markers in small intestine at postoperative day 1
研究概览
简要总结
Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is being accepted in the West as a treatment option for managing POI and various functional gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who underwent gastric surgery for a later large-scale study.
详细描述
Before surgery, patients were randomized (using simple randomization) to either acupuncture (A) group or non-acupuncture (NA) group. In both groups, sitz markers were inserted in duodenum or jejunum during surgery for detection of postoperative remnant sitz markers by Xray. In the A group, acupuncture treatment was given once daily for up to 5 consecutive days starting on postoperative day 1. The acupuncture points which were used were based on traditional Korean medicine. No acupuncture treatment was performed in the NA group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective surgery for gastric cancers
- •Patients with American Society of Anesthesiologists grades I-III
- •Patients who provided written informed consent
排除标准
- •Patients who developed intraoperative problems or complications
- •Patients with contraindications to had electrical stimulation devices (pacemaker or implantable defibrillator)
- •Patients who were allergic to acupuncture needle
结局指标
主要结局
Remnant sitz markers in small intestine at postoperative day 1
时间窗: measured in postoperative day 1
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 1.
Remnant sitz markers in small intestine at postoperative day 3
时间窗: measured in postoperative day 3
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 3.
Remnant sitz markers in small intestine at postoperative day 5
时间窗: measured in postoperative day 5
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 5.
Remnant sitz markers in small intestine at postoperative day 7
时间窗: measured in postoperative day 7
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 7.
次要结局
- Time to first flatus(up to 5 dyas)
- start of water intake(up to 7days)
- start of soft diet(up to 7days)
- hospital stay(up to 2 weeks)
研究者
In-Hwan Kim
Doctor
Daegu Catholic University Medical Center