Gastrointestinal Neoplasms
Conditions
Keywords
Acupuncture Therapy, Laparoscopic Surgery, Gastrointestinal Tract Recovery of Function
Brief summary
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.
Interventions
PROCEDURELaparoscopic Surgery
DEVICEAcupuncture treatment
Sponsors
Xiaonan Cui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03. | day 1, day 3, day 5, day 7 after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The quality of life questionnaire(QLQ). | day 1, day 3, day 5, day 7 after surgery | Assessing in 5 grade, mainly include appetite, sleep, pain,etc. |
| Stress hormone in blood. | day 2, day 7 after surgery | Estradiol (female), progesterone (female), testosterone (male) |
| Immune cell number ratio in blood. | day 2, day 7 after surgery | Th1/Th2, Th17/Treg |
Countries
China
Contacts
Primary ContactXiaonan Cui, MD, PhD
Outcome results
None listed