NCT03724656

Brief Summary

  1. 1.Research name: Effects of intraoperative stimulation of acupoints on postoperative gastrointestinal motility recovery in patients undergoing non-gastrointestinal abdominal surgery.
  2. 2.Research center: Multicenter research
  3. 3.Research design: A randomized controlled study method would be used in this study, in which the investigators would provide electroacupuncture on the basis of general anesthesia for non-gastrointestinal abdominal surgery. The effects of electroacupuncture on postoperative gastrointestinal motility recovery in patients undergoing non-gastrointestinal abdominal surgery will be observed and compared with the control group.
  4. 4.Research population: Patients who are greater or equal to 18 years old and less than 64 years old , meanwhile intend to receive selective/limited non-gastrointestinal surgery under general anesthesia.
  5. 5.Number of participants: 600
  6. 6.Interventions: The treatment group received electroacupuncture intervention 30 minutes before induction of anesthesia. In the treatment group, bilateral Neiguan point, bilateral Zusanli point and bilateral Hegu point were selected, then electroacupuncture was applied and the needle was retained until the end of operation. The control group was treated with non-acupoint shallow acupuncture method. The needle was inserted 5 cm beside the acupoint and the needling depth was less than 2 mm. At the same time, the manual stimulation was avoided, "Deqi" was not obtained, electroacupuncture was applied, electric current was regulated, and the needle was retained until the end of the operation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

October 28, 2018

Last Update Submit

March 6, 2019

Conditions

Gastrointestinal Dysfunction

Keywords

Transcutaneous Acupoint Electrical Stimulationnon-gastrointestinal abdominal surgerygastrointestinal motility

Outcome Measures

Primary Outcomes (1)

  • postoperative venting

    Record the time from the end of the procedure to the patient's first venting after operation

    an average of 1 year

Secondary Outcomes (3)

  • Biochemical tests

    12 months

  • bowel sounds and defecation

    an average of 1 year

  • Postoperative nausea and vomiting

    12 months

Study Arms (2)

acupuncture treatment

EXPERIMENTAL

Patients in the TAES treatment group received Transcutaneous Acupoint Electrical Stimulation(TAES) 30 minutes before induction of anesthesia. Bilateral Neiguan（PC6）, bilateral Zusanli（ST36）and bilateral Hegu （LI4）point were selected by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After "Deqi", electroacupuncture stimulation apparatus is connected and maintained until the end of operation.

Device: acupuncture treatment

Sham acupuncture treatment

SHAM COMPARATOR

The control group was treated with non-acupoint shallow acupuncture method. The needle was inserted 5 cm beside the acupoint and the needling depth was less than 2 mm. At the same time, the manual stimulation and "Deqi" was avoided.

Device: sham acupuncture treatment

Interventions

acupuncture treatmentDEVICE

TAES treatment 30 minutes before induction of anesthesia. Bilateral Neiguan（PC6）, bilateral Zusanli（ST36）and bilateral Hegu （LI4）point were selected by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After "Deqi", electroacupuncture stimulation apparatus is connected and maintained until the end of operation.

acupuncture treatment
sham acupuncture treatmentDEVICE

Participants in the sham acupuncture group received shallow needling (0.30mm×25mm) at bilateral sham points(nonacupoints located 5cm beside acupoints, about 20mm). The control group was treated with non-acupoint shallow acupuncture method and the needling depth was less than 2 mm. At the same time, the manual stimulation and "Deqi" was avoided.

Sham acupuncture treatment

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects enrolled in this study must accord with all of the following criteria:
  • Age ≥ 18 years old and \<64 years old, gender, ethnicity is not limited;
  • It is intended to selective/limited non-gastrointestinal surgery under general anesthesia;
  • Agree to participate in the study and sign an informed consent form;

You may not qualify if:

  • Refusing to participate in this study;
  • Patients with cardiac pacemakers and some special groups, such as pregnant women and those who have had many long-term acupuncture treatment experience;
  • Patients with peptic ulcer, perforation or obstruction;
  • Patients with chronic liver and renal dysfunction, and those who use β-blockers or antihypertensive drugs;
  • The attending doctors or researchers believe that there are other unsuitable situations for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lee CH, Kim DK, Yook TH, Sasaki M, Kitamura N. Effectiveness of electroacupuncture at Zusanli (ST36) on the immunohistochemical density of enteroendocrine cells related to gastrointestinal function. J Acupunct Meridian Stud. 2012 Apr;5(2):63-71. doi: 10.1016/j.jams.2012.01.002. Epub 2012 Feb 4.

    PMID: 22483184BACKGROUND

  • Wang CP, Kao CH, Chen WK, Lo WY, Hsieh CL. A single-blinded, randomized pilot study evaluating effects of electroacupuncture in diabetic patients with symptoms suggestive of gastroparesis. J Altern Complement Med. 2008 Sep;14(7):833-9. doi: 10.1089/acm.2008.0107.

    PMID: 18721079BACKGROUND

  • Gungorduk K, Ozdemir IA, Gungorduk O, Gulseren V, Gokcu M, Sanci M. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial. Am J Obstet Gynecol. 2017 Feb;216(2):145.e1-145.e7. doi: 10.1016/j.ajog.2016.10.019. Epub 2016 Oct 22.

    PMID: 27780709BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Yu Jianbo, Professor

    Nankai Hospital of Tianjin

    STUDY CHAIR

Central Study Contacts

Zhang Yuan, PhD

CONTACT

1364206636113642066361@126.com

Yu Jianbo, Professor

CONTACT

（022）27435008yujianbo11@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor Affiliation: Tianjin Nankai Hospital

Study Record Dates

First Submitted

October 28, 2018

First Posted

October 30, 2018

Study Start

March 1, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share