NCT03086304

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
610

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

10 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 28, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

March 3, 2017

Last Update Submit

November 18, 2019

Conditions

Postoperative Intestinal Obstruction

Keywords

postoperative intestinal obstruction;TEAS

Outcome Measures

Primary Outcomes (1)

  • Incidence of POI

    Whether or not to exhaust in 72 hours after surgery

    72 hours after surgery

Secondary Outcomes (5)

  • postoperative gastrointestinal function recovery

    once a week for 30 days after surgery

  • recovery of bowel sounds

    1-3 days after surgery

  • adverse reactions of digestive after surgery

    1-3 days after surgery

  • surgery complications

    once a week for 30 days after surgery

  • recovery index

    once a week for 30 days after surgery

Study Arms (2)

TEAS group

EXPERIMENTAL

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.

Device: transcutaneous acupoint electrical stimulation

no TEAS group

EXPERIMENTAL

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.

Device: no transcutaneous acupoint electrical stimulation

Interventions

transcutaneous acupoint electrical stimulationDEVICE

Transcutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points.

TEAS group
no transcutaneous acupoint electrical stimulationDEVICE

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

no TEAS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ankang Central Hospital

Ankang, Shaanxi, 029725000, China

Location

Ankang Hospital of Traditional Chinese Medicine

Ankang, Shaanxi, 029725000, China

Location

Weinan Central Hospital

Weinan, Shaanxi, 029714000, China

Location

Xi'an Central Hospital

Xi'an, Shaanxi, 029710003, China

Location

Xi'an Hospital of traditional Chinese Medicine

Xi'an, Shaanxi, 029710021, China

Location

Central Railway Group of Xi'an Central Hospital

Xi'an, Shaanxi, 029710054, China

Location

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 029710061, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 029710068, China

Location

Affiliated Hospital of Shaanxi University of traditional Chinese Medicine

Xianyang, Shaanxi, 029712000, China

Location

Affiliated Hospital of Yan'an University

Yan’an, Shaanxi, 029716000, China

Location

Study Officials

  • Qiang Wang, PHD

    First Affiliated Hospital of Xian JiaotongUniversity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomised Controlled Trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 22, 2017

Study Start

May 28, 2018

Primary Completion

September 3, 2019

Study Completion

September 30, 2019

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

CN(10)