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TEAS Enhanced Recovery After Laparoscopic Colon Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02921529
Acronym
ARCO
Enrollment
100
Registered
2016-10-03
Start date
2016-11-30
Completion date
2018-04-30
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Recovery

Keywords

Postoperative recovery, colon surgery

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.

Interventions

OTHERTEAS

Electric stimulation was given through electrode attached to specific acupoints

OTHERfalse stimulation

Electrodes were attached to specific acupoints without electric current

Sponsors

Zhihong LU
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

Inventions were given by an investigator who is not involved in patient care. The anesthetists, surgeons,staff in the ward, the one who record the outcomes, and data analyzer were all blinded to the group allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Time to meeting discharge criteriaend of the surgery to discharge,with an average of 7 days

Secondary

MeasureTime frameDescription
Time to first defecationend of the surgery to discharge,with an average of 7 days
Incidence of postoperative complicationsend of the surgery to discharge,with an average of 7 days
Time to first oral intake of waterend of the surgery to discharge,with an average of 7 days
visual analogue scaleend of surgery to 24 hours, 48 hours, and 72 hours after surgery0 is for no pain, 10 is for pain that can not be tolerated
Time to first flatusend of the surgery to discharge,with an average of 7 days
quality of sleeping scoreend of surgery to 24 hours, 48 hours, and 72 hours after surgery0 is for totally insomnia, 10 is for perfect sleep
quality of recoveryend of surgery to 24 hours, 48 hours, and 72 hours after surgeryusing a questionaire including 15 items that covering postoperative recovery
expenseend of the surgery to discharge,with an average of 7 dayspatients' cost after surgery
incidence of nausea and vomitingend of surgery to 24 hours, 48 hours, and 72 hours after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026