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Completed

NCT Number: NCT02921529

TEAS Enhanced Recovery After Laparoscopic Colon Surgery

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Afiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEAS

Other

Electric stimulation was given through electrode attached to specific acupoints

Other names: Acupuncture, Electric stimulation

false stimulation

Other

Electrodes were attached to specific acupoints without electric current

Other names: sham stimulation

Primary outcomes

  1. Time to meeting discharge criteria

    Time frame: end of the surgery to discharge,with an average of 7 days

Secondary outcomes

  1. Time to first flatus

    Time frame: end of the surgery to discharge,with an average of 7 days

  2. Time to first defecation

    Time frame: end of the surgery to discharge,with an average of 7 days

  3. Incidence of postoperative complications

    Time frame: end of the surgery to discharge,with an average of 7 days

  4. Time to first oral intake of water

    Time frame: end of the surgery to discharge,with an average of 7 days

  5. 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

  6. incidence of nausea and vomiting

    Time frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery

  7. 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

  8. 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

  9. expense

    Time frame: end of the surgery to discharge,with an average of 7 days

    patients' cost after surgery

Sponsors and collaborators

Lead sponsor

Zhihong LU

Other

Registry information

Official study title

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

Acronym: ARCO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2016
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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