Clinical trial NCT02921529: TEAS Enhanced Recovery After Laparoscopic Colon Surgery
Official title: Perioperative Transcutaneous Electrical Acupoint Stimulation for Enhanced Recovery After Laparoscopic Colon Surgery:a Multi-center Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Recovery
Keywords: Postoperative recovery
colon surgery
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to meeting discharge criteria
timeFrame: end of the surgery to discharge,with an average of 7 days
Secondary outcomes:
measure: Time to first flatus
timeFrame: end of the surgery to discharge,with an average of 7 days
measure: Time to first defecation
timeFrame: end of the surgery to discharge,with an average of 7 days
measure: Incidence of postoperative complications
timeFrame: end of the surgery to discharge,with an average of 7 days
measure: Time to first oral intake of water
timeFrame: end of the surgery to discharge,with an average of 7 days
measure: visual analogue scale
timeFrame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
measure: incidence of nausea and vomiting
timeFrame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
measure: quality of sleeping score
timeFrame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
measure: quality of recovery
timeFrame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
measure: expense
timeFrame: end of the surgery to discharge,with an average of 7 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Afiliated Hospital of Chongqing Medical University
state: Chongqing
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References: