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

Primary Purpose

Postoperative Intestinal Obstruction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous acupoint electrical stimulation
no transcutaneous acupoint electrical stimulation
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Intestinal Obstruction focused on measuring postoperative intestinal obstruction;TEAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TEAS group

no TEAS group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2017
Last Updated
November 18, 2019
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03086304
Brief Title
Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery
Acronym
TAESRIOGS
Official Title
Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Intestinal Obstruction
Keywords
postoperative intestinal obstruction;TEAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Randomised Controlled Trial
Allocation
Randomized
Enrollment
610 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEAS group
Arm Type
Experimental
Arm 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.
Arm Title
no TEAS group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
transcutaneous acupoint electrical stimulation
Intervention Description
Transcutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points.
Intervention Type
Device
Intervention Name(s)
no transcutaneous acupoint electrical stimulation
Intervention Description
the choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation.
Primary Outcome Measure Information:
Title
Incidence of POI
Description
Whether or not to exhaust in 72 hours after surgery
Time Frame
72 hours after surgery
Secondary Outcome Measure Information:
Title
postoperative gastrointestinal function recovery
Description
the time of postoperative exhaustion and defecation.
Time Frame
once a week for 30 days after surgery
Title
recovery of bowel sounds
Description
the recovery time of bowel sounds
Time Frame
1-3 days after surgery
Title
adverse reactions of digestive after surgery
Description
the incidence and score of distention, abdominal pain, nausea and vomiting after surgery.
Time Frame
1-3 days after surgery
Title
surgery complications
Description
wound infection ,pneumonia, anastomotic leakage,urethritis,uroschesis
Time Frame
once a week for 30 days after surgery
Title
recovery index
Description
the leaving bed time,normal diet recovery time,post-operative hospitalization duration
Time Frame
once a week for 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wang, PHD
Organizational Affiliation
First Affiliated Hospital of Xian JiaotongUniversity
Official's Role
Study Chair
Facility Information:
Facility Name
Ankang Central Hospital
City
Ankang
State/Province
Shaanxi
ZIP/Postal Code
029725000
Country
China
Facility Name
Ankang Hospital of Traditional Chinese Medicine
City
Ankang
State/Province
Shaanxi
ZIP/Postal Code
029725000
Country
China
Facility Name
Weinan Central Hospital
City
Weinan
State/Province
Shaanxi
ZIP/Postal Code
029714000
Country
China
Facility Name
Xi'an Central Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
029710003
Country
China
Facility Name
Xi'an Hospital of traditional Chinese Medicine
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
029710021
Country
China
Facility Name
Central Railway Group of Xi'an Central Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
029710054
Country
China
Facility Name
First Affiliated Hospital of Xian JiaotongUniversity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
029710061
Country
China
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
029710068
Country
China
Facility Name
Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
City
Xianyang
State/Province
Shaanxi
ZIP/Postal Code
029712000
Country
China
Facility Name
Affiliated Hospital of Yan'an University
City
Yan'an
State/Province
Shaanxi
ZIP/Postal Code
029716000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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