Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery

Study Overview
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Brief Summary
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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.

Conditions
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Gastrointestinal Neoplasms

Intervention / Treatment
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* Procedure: Laparoscopic Surgery
* Device: Acupuncture treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparator Group<br>Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy. | Procedure: Laparoscopic Surgery<br> <br> |
| Experimental: Acupuncture Therapy Group<br>Patients received gastrointestinal neoplasms laparoscopic surgery and acupuncture therapy. Finish surgery up to 24 hours electricity acupuncture treatment, treatment 1 times a day, every time lasted 30 minutes, 5 days in a row | Procedure: Laparoscopic Surgery<br> <br> Device: Acupuncture treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of life questionnaire(QLQ). | Assessing in 5 grade, mainly include appetite, sleep, pain,etc. | day 1, day 3, day 5, day 7 after surgery | 
| Stress hormone in blood. | Estradiol (female), progesterone (female), testosterone (male) | day 2, day 7 after surgery | 
| Immune cell number ratio in blood. | Th1/Th2, Th17/Treg | day 2, day 7 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture Therapy, Laparoscopic Surgery, Gastrointestinal Tract Recovery of Function