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

Postoperative Intestinal Obstruction Clinical Trial

— TAESRIOGS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086304
• Other study ID #: XJTU1AF-CRF-2016-003
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: September 30, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Obstruction
• Postoperative Intestinal Obstruction

Intervention

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.
• no transcutaneous acupoint electrical stimulation
the choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation.

Locations

Country	Name	City	State
China	Ankang Central Hospital	Ankang	Shaanxi
China	Ankang Hospital of Traditional Chinese Medicine	Ankang	Shaanxi
China	Weinan Central Hospital	Weinan	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	Xi'an Central Hospital	Xi'an	Shaanxi
China	Xi'an Hospital of traditional Chinese Medicine	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

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of POI	Whether or not to exhaust in 72 hours after surgery	72 hours after surgery
Secondary	postoperative gastrointestinal function recovery	the time of postoperative exhaustion and defecation.	once a week for 30 days after surgery
Secondary	recovery of bowel sounds	the recovery time of bowel sounds	1-3 days after surgery
Secondary	adverse reactions of digestive after surgery	the incidence and score of distention, abdominal pain, nausea and vomiting after surgery.	1-3 days after surgery
Secondary	surgery complications	wound infection ,pneumonia, anastomotic leakage,urethritis,uroschesis	once a week for 30 days after surgery
Secondary	recovery index	the leaving bed time,normal diet recovery time,post-operative hospitalization duration	once a week for 30 days after surgery