TEAS Enhanced Recovery After Laparoscopic Colon Surgery

Study Overview
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Brief Summary
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The purpose of this study is to observe the effects of transcutaneous electrical acupoint stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery.

Detailed Description
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Patients were randomly assigned to two groups, receiving TEAS andno stimulation respectively. Interventions were given 30min before anesthesia and 1, 2 , 3 day after surgery, lasted 30min each time . The acupoints of TEAS group are bilateral ST36/SP6 combined with PC6/LI4, and the control group only attach electrodes without electric current. The frequency of TEAS is set to 2/10 Hz. After surgery, the time of meeting discharge criteria, first flatus and defecation were recorded. Score of PONV, life quality, sleep quality and VAS of pain were evaluated 24, 48 and 72h after surgery. The postoperative complications, re-exploration, cost of hospitalization and adverse events were also recorded.

Official Title
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Perioperative Transcutaneous Electrical Acupoint Stimulation for Enhanced Recovery After Laparoscopic Colon Surgery:a Multi-center Randomized Controlled Clinical Trial

Conditions
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Postoperative Recovery

Intervention / Treatment
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* Other: TEAS
* Other: false stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 to 75 years old； ASA I-III； Scheduled for elective laparoscopic colon surgery under general anesthesia； BMI between 18 and 30； Informed consented. Exclusion Criteria: Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints； Patients with difficulty in communication； Emergency surgery； Patients who are with distant metastasis; Patients who are with history of myocardial infarction or cerebral infarction in the past six months； Patients who are with long history of taking NSAIDS，hormone or immunosuppressive agents； Patients who are recruited in other clinical trials in the last 3 months； Other situations researcher think shouldn't be included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAS<br>Patients were given 30min of TEAS(transcutaneous electrical acupoint stimulation) before anesthesia and 1,2,3 day after surgery | Other: TEAS<br>* Electric stimulation was given through electrode attached to specific acupoints<br>* Other names: Electric stimulation;|
| Sham Comparator: false stimulation<br>Attach electrodes without electric current | Other: false stimulation<br>* Electrodes were attached to specific acupoints without electric current<br>* Other names: sham stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meeting discharge criteria |  | end of the surgery to discharge,with an average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first flatus |  | end of the surgery to discharge,with an average of 7 days | 
| Time to first defecation |  | end of the surgery to discharge,with an average of 7 days | 
| Incidence of postoperative complications |  | end of the surgery to discharge,with an average of 7 days | 
| Time to first oral intake of water |  | end of the surgery to discharge,with an average of 7 days | 
| visual analogue scale | 0 is for no pain, 10 is for pain that can not be tolerated | end of surgery to 24 hours, 48 hours, and 72 hours after surgery | 
| incidence of nausea and vomiting |  | end of surgery to 24 hours, 48 hours, and 72 hours after surgery | 
| quality of sleeping score | 0 is for totally insomnia, 10 is for perfect sleep | end of surgery to 24 hours, 48 hours, and 72 hours after surgery | 
| quality of recovery | using a questionaire including 15 items that covering postoperative recovery | end of surgery to 24 hours, 48 hours, and 72 hours after surgery | 
| expense | patients' cost after surgery | end of the surgery to discharge,with an average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative recovery, colon surgery