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Completed

NCT Number: NCT03086304

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankang Central Hospital, Ankang, Shaanxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcutaneous acupoint electrical stimulation

Device

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

Device

the choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation.

Primary outcomes

  1. Incidence of POI

    Time frame: 72 hours after surgery

    Whether or not to exhaust in 72 hours after surgery

Secondary outcomes

  1. postoperative gastrointestinal function recovery

    Time frame: once a week for 30 days after surgery

    the time of postoperative exhaustion and defecation.

  2. recovery of bowel sounds

    Time frame: 1-3 days after surgery

    the recovery time of bowel sounds

  3. adverse reactions of digestive after surgery

    Time frame: 1-3 days after surgery

    the incidence and score of distention, abdominal pain, nausea and vomiting after surgery.

  4. surgery complications

    Time frame: once a week for 30 days after surgery

    wound infection ,pneumonia, anastomotic leakage,urethritis,uroschesis

  5. recovery index

    Time frame: once a week for 30 days after surgery

    the leaving bed time,normal diet recovery time,post-operative hospitalization duration

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TAESRIOGS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.