TEAS Enhanced Recovery After Laparoscopic Colon Surgery

Not Applicable

Completed

• Conditions: Postoperative Recovery
• Interventions: Other: false stimulation; Other: TEAS

• Registration Number: NCT02921529
• Lead Sponsor: Zhihong LU

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.

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Study Start: 2016-11
• Primary Completion: 2018-03
• Study Completion: 2018-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
false stimulation	false stimulation	Attach electrodes without electric current
TEAS	TEAS	Patients were given 30min of TEAS(transcutaneous electrical acupoint stimulation) before anesthesia and 1,2,3 day after surgery

Primary Outcome Measures

Name	Time	Method
Time to meeting discharge criteria	end of the surgery to discharge,with an average of 7 days

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

First Afiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China