Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma
Keywords
Abstract
Dates
| Last Verified: | 12/31/2018 |
| First Submitted: | 08/02/2016 |
| Estimated Enrollment Submitted: | 08/14/2016 |
| First Posted: | 08/17/2016 |
| Last Update Submitted: | 01/23/2019 |
| Last Update Posted: | 01/24/2019 |
| Actual Study Start Date: | 07/31/2016 |
| Estimated Primary Completion Date: | 12/31/2018 |
| Estimated Study Completion Date: | 12/31/2018 |
Condition or disease
Intervention/treatment
Device: Experimental group
Procedure: Laparoscopic Surgery
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Control group This group receives normal treatment after surgery,with no acupuncture. | |
| Experimental: Experimental group 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. | Device: Experimental group |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS) [day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery]
Secondary Outcome Measures
1. Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability [day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery]
2. Prostaglandin E2(PGE2) in blood [day 2,day 7 after surgery]
3. Estradiol(Female) in blood [day 2, day 7 after surgery]
4. Th1/Th2 in blood [day 2, day 7 after surgery]
5. 5-Hydroxytryptamine(5-HT) in blood [day 2,day 7 after surgery]
6. Histamine(HIS) in blood [day 2,day 7 after surgery]
7. Th17/Treg in blood [day 2, day 7 after surgery]
8. Testosterone(Male) in blood [day 2,day 7 after surgery]
