TEAS Enhanced Recovery After Laparoscopic Colon Surgery (ARCO)

June 4, 2018 updated by: Zhihong LU

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • First Afiliated Hospital of Chongqing Medical University
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to meeting discharge criteria
Time Frame: end of the surgery to discharge,with an average of 7 days
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
Time Frame: end of the surgery to discharge,with an average of 7 days
end of the surgery to discharge,with an average of 7 days
Time to first defecation
Time Frame: end of the surgery to discharge,with an average of 7 days
end of the surgery to discharge,with an average of 7 days
Incidence of postoperative complications
Time Frame: end of the surgery to discharge,with an average of 7 days
end of the surgery to discharge,with an average of 7 days
Time to first oral intake of water
Time Frame: end of the surgery to discharge,with an average of 7 days
end of the surgery to discharge,with an average of 7 days
visual analogue scale
Time Frame: 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
end of surgery to 24 hours, 48 hours, and 72 hours after surgery
incidence of nausea and vomiting
Time Frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
end of surgery to 24 hours, 48 hours, and 72 hours after surgery
quality of sleeping score
Time Frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
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
Time Frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
using a questionaire including 15 items that covering postoperative recovery
end of surgery to 24 hours, 48 hours, and 72 hours after surgery
expense
Time Frame: end of the surgery to discharge,with an average of 7 days
patients' cost after surgery
end of the surgery to discharge,with an average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhihong LU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XJH-A-2016-09-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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