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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Completed

CT.gov ID

NCT03086304

Collaborator

Shaanxi Provincial People's Hospital (Other), Xi'an Central Hospital (Other), Ankang Hospital of Traditional Chinese Medicine (Other), Affiliated Hospital of Shaanxi University of traditional Chinese Medicine (Other), Ankang Central Hospital (Other), Weinan Central Hospital (Other), Central Railway Group of Xi'an Central Hospital (Other), Xi'an Hospital of traditional Chinese Medicine (Other), Yan'an University Affiliated Hospital (Other)

610

Enrollment

Locations

Arms

16.1

Actual Duration (Months)

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Intestinal Obstruction	Device: transcutaneous acupoint electrical stimulation Device: no transcutaneous acupoint electrical stimulation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

610 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Randomised Controlled Trial

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 28, 2018

Actual Primary Completion Date :

Sep 3, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: transcutaneous acupoint electrical stimulation Transcutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points.
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Device: transcutaneous acupoint electrical stimulation

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

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of POI [72 hours after surgery]
Whether or not to exhaust in 72 hours after surgery

Secondary Outcome Measures

postoperative gastrointestinal function recovery [once a week for 30 days after surgery]
the time of postoperative exhaustion and defecation.
recovery of bowel sounds [1-3 days after surgery]
the recovery time of bowel sounds
adverse reactions of digestive after surgery [1-3 days after surgery]
the incidence and score of distention, abdominal pain, nausea and vomiting after surgery.
surgery complications [once a week for 30 days after surgery]
wound infection ,pneumonia, anastomotic leakage,urethritis,uroschesis
recovery index [once a week for 30 days after surgery]
the leaving bed time,normal diet recovery time,post-operative hospitalization duration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankang Central Hospital	Ankang	Shaanxi	China	029725000
2	Ankang Hospital of Traditional Chinese Medicine	Ankang	Shaanxi	China	029725000
3	Weinan Central Hospital	Weinan	Shaanxi	China	029714000
4	Xi'an Central Hospital	Xi'an	Shaanxi	China	029710003
5	Xi'an Hospital of traditional Chinese Medicine	Xi'an	Shaanxi	China	029710021
6	Central Railway Group of Xi'an Central Hospital	Xi'an	Shaanxi	China	029710054
7	First Affiliated Hospital of Xian JiaotongUniversity	Xi'an	Shaanxi	China	029710061
8	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi	China	029710068
9	Affiliated Hospital of Shaanxi University of traditional Chinese Medicine	Xianyang	Shaanxi	China	029712000
10	Affiliated Hospital of Yan'an University	Yan'an	Shaanxi	China	029716000

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Xi'an Central Hospital
Ankang Hospital of Traditional Chinese Medicine
Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
Ankang Central Hospital
Weinan Central Hospital
Central Railway Group of Xi'an Central Hospital
Xi'an Hospital of traditional Chinese Medicine
Yan'an University Affiliated Hospital

Investigators

Study Chair: Qiang Wang, PHD, First Affiliated Hospital of Xian JiaotongUniversity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT03086304

Other Study ID Numbers:

XJTU1AF-CRF-2016-003

First Posted:

Mar 22, 2017

Last Update Posted:

Nov 19, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University

postoperative intestinal obstruction;TEAS

Additional relevant MeSH terms:

Intestinal Obstruction

Study Results

No Results Posted as of Nov 19, 2019