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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Intestinal Obstruction
• Intervention / Treatment: Device: transcutaneous acupoint electrical stimulation; Device: no transcutaneous acupoint electrical stimulation

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 Type: Interventional
• Enrollment (Actual): 610
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Ankang, Shaanxi, China, 029725000
      • Ankang Central Hospital
    • Ankang, Shaanxi, China, 029725000
      • Ankang HospitaL of Traditional Chinese Medicine
    • Weinan, Shaanxi, China, 029714000
      • weinan Central Hospital
    • Xi'an, Shaanxi, China, 029710003
      • Xi'an Central Hospital
    • Xi'an, Shaanxi, China, 029710021
      • Xi'an Hospital of traditional Chinese Medicine
    • Xi'an, Shaanxi, China, 029710054
      • Central Railway Group of Xi'an Central Hospital
    • Xi'an, Shaanxi, China, 029710061
      • First Affiliated Hospital of Xian JiaotongUniversity
    • Xi'an, Shaanxi, China, 029710068
      • Shaanxi Provincial People's Hospital
    • Xianyang, Shaanxi, China, 029712000
      • Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
    • Yan'an, Shaanxi, China, 029716000
      • Affiliated Hospital of Yan'an University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of POI	Whether or not to exhaust in 72 hours after surgery	72 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Xi'an Central Hospital; Shaanxi Provincial People's 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 record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): September 3, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: postoperative intestinal obstruction;TEAS
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: XJTU1AF-CRF-2016-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No