Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery (TAESRIOGS)

Xi'an Jiaotong University

Status: Completed

Conditions: Postoperative Intestinal Obstruction

Treatments: Device: transcutaneous acupoint electrical stimulation; Device: no transcutaneous acupoint electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03086304

XJTU1AF-CRF-2016-003

Details and patient eligibility

About

Postoperative intestinal obstruction (POI) is one of the most common complications in the gastrointestinal surgery. Compared with the conventional control group, transcutaneous acupoint electrical stimulation(TEAS) is possible to reduce the incidence of POI and accelerate the rapid recovery of the gastrointestinal tract.

Full description

Participants will be randomly assigned, in a 1:1 ratio, to receive TEAS or Blank treatment (acupoints selection are same with the experimental group, connect stimulator for patients, but not don't give stimulus). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. TEAS will be performed in a series of time periods after operation. Time of first fart and food-taking ,time of have normal diet after the transplantation will be recorded. The participation of each patient is scheduled for 30 days.

Enrollment: 610 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All the patients signed the informed consent before treatment;
• Age ≥ 18 years old,American society of Anesthesiologists(ASA)grade are between I and III;
• Plan to perform elective colon and rectal tumor resection under general anesthesia;
• not involved in other clinical studies;
• no cognitive impairment, mental disorders,communication disorders.

Exclusion criteria

• Pregnancy, breast-feeding;
• The history of intestinal surgery;
• Test point skin injury, infection, allergies to tape;
• have undergone external enterostomy;
• Chief surgeon refuse to cooperate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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610 participants in 2 patient groups

TEAS group

Experimental group

Description:

Choose several acupoints,give 2/10 hz dilatational wave stimulation.Complete the 30 minutes intervention after extubation and 1-3 days after surgery.Give a health education on the first postoperative day.

Treatment:

Device: transcutaneous acupoint electrical stimulation

no TEAS group

Experimental group

Description:

The choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation,the others steps are same with TEAS group.

Treatment:

Device: no transcutaneous acupoint electrical stimulation