TEAS Enhanced Recovery After Laparoscopic Colon Surgery

NCT ID: NCT02921529

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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TEAS

Patients were given 30min of TEAS(transcutaneous electrical acupoint stimulation) before anesthesia and 1,2,3 day after surgery

Group Type EXPERIMENTAL

TEAS

Intervention Type OTHER

Electric stimulation was given through electrode attached to specific acupoints

false stimulation

Attach electrodes without electric current

Group Type SHAM_COMPARATOR

false stimulation

Intervention Type OTHER

Electrodes were attached to specific acupoints without electric current

Interventions

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TEAS

Electric stimulation was given through electrode attached to specific acupoints

Intervention Type OTHER

false stimulation

Electrodes were attached to specific acupoints without electric current

Intervention Type OTHER

Other Intervention Names

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Acupuncture Electric stimulation sham stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhihong LU

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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First Afiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Tongji Hospital

Wuhan, Hubei, China

Site Status

Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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XJH-A-2016-09-01

Identifier Type: -

Identifier Source: org_study_id

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