TEAS Enhanced Recovery After Laparoscopic Colon Surgery

Postoperative Recovery Clinical Trial

— ARCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921529
• Other study ID #: XJH-A-2016-09-01
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: April 2018

Study information

• Verified date: June 2018
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Recovery

Intervention

Other:
• TEAS
Electric stimulation was given through electrode attached to specific acupoints
• false stimulation
Electrodes were attached to specific acupoints without electric current

Locations

Country	Name	City	State
China	First Afiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Tongji Hospital	Wuhan	Hubei
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to meeting discharge criteria		end of the surgery to discharge,with an average of 7 days
Secondary	Time to first flatus		end of the surgery to discharge,with an average of 7 days
Secondary	Time to first defecation		end of the surgery to discharge,with an average of 7 days
Secondary	Incidence of postoperative complications		end of the surgery to discharge,with an average of 7 days
Secondary	Time to first oral intake of water		end of the surgery to discharge,with an average of 7 days
Secondary	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
Secondary	incidence of nausea and vomiting		end of surgery to 24 hours, 48 hours, and 72 hours after surgery
Secondary	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
Secondary	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
Secondary	expense	patients' cost after surgery	end of the surgery to discharge,with an average of 7 days