Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)

NCT ID: NCT02480361

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

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Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is being accepted in the West as a treatment option for managing POI and various functional gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who underwent gastric surgery for a later large-scale study.

Detailed Description

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Before surgery, patients were randomized (using simple randomization) to either acupuncture (A) group or non-acupuncture (NA) group. In both groups, sitz markers were inserted in duodenum or jejunum during surgery for detection of postoperative remnant sitz markers by Xray. In the A group, acupuncture treatment was given once daily for up to 5 consecutive days starting on postoperative day 1. The acupuncture points which were used were based on traditional Korean medicine. No acupuncture treatment was performed in the NA group.

Conditions

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Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Acupuncture

The patients who were received acupuncture after gastric cancer surgery

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

Acupuncture treatment after gastric cancer surgery during 5 postoperative days

Non-acupuncture

The patients who were not received acupuncture after gastric cancer surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupuncture

Acupuncture treatment after gastric cancer surgery during 5 postoperative days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective surgery for gastric cancers
* Patients with American Society of Anesthesiologists grades I-III
* Patients who provided written informed consent

Exclusion Criteria

* Patients who developed intraoperative problems or complications
* Patients with contraindications to had electrical stimulation devices (pacemaker or implantable defibrillator)
* Patients who were allergic to acupuncture needle
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daegu Catholic University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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In-Hwan Kim

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun-dong Chae, Professor

Role: STUDY_DIRECTOR

Department of Surgery, School of Medicine, Catholic University of Daegu

Other Identifiers

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APOIGC-13

Identifier Type: -

Identifier Source: org_study_id

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