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

NCT ID: NCT03086304

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 610 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-28
• Study Completion Date: 2019-09-30

Brief Summary

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.

Detailed 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.

Conditions

Postoperative Intestinal Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TEAS group

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.

Group Type: EXPERIMENTAL

transcutaneous acupoint electrical stimulation

Intervention Type: DEVICE

Transcutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points.

no TEAS group

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.

Group Type: EXPERIMENTAL

no transcutaneous acupoint electrical stimulation

Intervention Type: DEVICE

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

Interventions

transcutaneous acupoint electrical stimulation

Transcutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points.

Intervention Type: DEVICE

no transcutaneous acupoint electrical stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Xi'an Central Hospital

OTHER

Sponsor Role: collaborator

Ankang Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Shaanxi University of traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Ankang Central Hospital

OTHER

Sponsor Role: collaborator

Weinan Central Hospital

OTHER

Sponsor Role: collaborator

Central Railway Group of Xi'an Central Hospital

UNKNOWN

Sponsor Role: collaborator

Xi'an Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Yan'an University Affiliated Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Wang, PHD

Role: STUDY_CHAIR

First Affiliated Hospital of Xian JiaotongUniversity

Locations

Ankang Central Hospital

Ankang, Shaanxi, China

Ankang Hospital of Traditional Chinese Medicine

Ankang, Shaanxi, China

Weinan Central Hospital

Weinan, Shaanxi, China

Xi'an Central Hospital

Xi'an, Shaanxi, China

Xi'an Hospital of traditional Chinese Medicine

Xi'an, Shaanxi, China

Central Railway Group of Xi'an Central Hospital

Xi'an, Shaanxi, China

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Affiliated Hospital of Shaanxi University of traditional Chinese Medicine

Xianyang, Shaanxi, China

Affiliated Hospital of Yan'an University

Yan’an, Shaanxi, China

Countries

China

Other Identifiers

XJTU1AF-CRF-2016-003

Identifier Type: -

Identifier Source: org_study_id