Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- Xiaonan Cui
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.
研究概览
简要总结
Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle section of the rectum will be as the research object. Cancer patients are diagnosed based on pathology or cell biology. The trial is randomized, parallel and open. They are randomized into 2 groups: both groups receive surgery. The experimental group receives conventional treatment combine with electroacupuncture Zusanli point .etc finish operation and the contrast receives the same conventional treatment with experimental group. Clinical evaluation includes gastrointestinal tract recovery of function, pain relief, life quality improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone, peroxidatic reaction and the ratio of immune cells.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight: 40kg-90kg, male and female.
- •Diagnosis: imaging, cell and pathology report.
- •Brain, heart, lung, liver, kidney are at good condition in 2 weeks before surgery.
- •No conscious obstacle and limbs disability.
排除标准
- •Fainting during acupuncture.
- •Electrolyte imbalance.
- •Serious and life-threatening complications after surgery.
- •In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
结局指标
主要结局
Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.
时间窗: day 1, day 3, day 5, day 7 after surgery
次要结局
- The quality of life questionnaire(QLQ).(day 1, day 3, day 5, day 7 after surgery)
- Stress hormone in blood.(day 2, day 7 after surgery)
- Immune cell number ratio in blood.(day 2, day 7 after surgery)
研究者
Xiaonan Cui
Professor, Chief physician
The First Affiliated Hospital of Dalian Medical University