Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma

Xiaonan Cui

Status: Completed

Conditions: Pain; Gastrointestinal Carcinoma

Treatments: Device: Acupuncture therapy; Procedure: Laparoscopic Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02871999

LCKY2016-39

Details and patient eligibility

About

Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
2. Pathology diagnosed;
3. Brain, heart, lung, liver, kidney are at good condition before surgery;
4. No mental disorder, no conscious obstacle, no limbs disability.

Exclusion criteria

1. Severely complication after surgery;
2. Contraindication of the acupuncture;
3. Patients with mental disease;
4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

This group receives normal treatment after surgery,with no acupuncture.

Treatment:

Procedure: Laparoscopic Surgery

Experimental group

Experimental group

Description:

This group receives acupuncture therapy besides normal treatment after surgery. The acupuncture therapy starts after 24 hours of surgery, 1 time a day, 30 minutes every time, until the fifth day.

Treatment:

Device: Acupuncture therapy

Procedure: Laparoscopic Surgery