Clinical trial NCT03086304: Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery
Official title: Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Intestinal Obstruction
Keywords: postoperative intestinal obstruction;TEAS
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Shaanxi Provincial People's Hospital
name: Xi'an Central Hospital
name: Ankang Hospital of Traditional Chinese Medicine
name: Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
name: Ankang Central Hospital
name: Weinan Central Hospital
name: Central Railway Group of Xi'an Central Hospital
name: Xi'an Hospital of Traditional Chinese Medicine
name: Yan'an University Affiliated Hospital
First posted: 2017-03-22
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of POI
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: postoperative gastrointestinal function recovery
timeFrame: once a week for 30 days after surgery
measure: recovery of bowel sounds
timeFrame: 1-3 days after surgery
measure: adverse reactions of digestive after surgery
timeFrame: 1-3 days after surgery
measure: surgery complications
timeFrame: once a week for 30 days after surgery
measure: recovery index
timeFrame: once a week for 30 days after surgery
Other outcomes:
Locations:
city: Ankang
country: China
facility: Ankang Central Hospital
state: Shaanxi
city: Ankang
country: China
facility: Ankang Hospital of Traditional Chinese Medicine
state: Shaanxi
city: Weinan
country: China
facility: Weinan Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Hospital of traditional Chinese Medicine
state: Shaanxi
city: Xi'an
country: China
facility: Central Railway Group of Xi'an Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian JiaotongUniversity
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
state: Shaanxi
city: Yan'an
country: China
facility: Affiliated Hospital of Yan'an University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian JiaotongUniversity
name: Qiang Wang, PHD
role: STUDY_CHAIR
References: