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

June 22, 2015 updated by: In-Hwan Kim, Daegu Catholic University Medical Center

Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
The patients who were received acupuncture after gastric cancer surgery
Acupuncture treatment after gastric cancer surgery during 5 postoperative days
No Intervention: Non-acupuncture
The patients who were not received acupuncture after gastric cancer surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remnant sitz markers in small intestine at postoperative day 1
Time Frame: measured in postoperative day 1
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 1.
measured in postoperative day 1
Remnant sitz markers in small intestine at postoperative day 3
Time Frame: measured in postoperative day 3
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 3.
measured in postoperative day 3
Remnant sitz markers in small intestine at postoperative day 5
Time Frame: measured in postoperative day 5
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 5.
measured in postoperative day 5
Remnant sitz markers in small intestine at postoperative day 7
Time Frame: measured in postoperative day 7
Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 7.
measured in postoperative day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first flatus
Time Frame: up to 5 dyas
up to 5 dyas
start of water intake
Time Frame: up to 7days
up to 7days
start of soft diet
Time Frame: up to 7days
up to 7days
hospital stay
Time Frame: up to 2 weeks
up to 2 weeks

Other Outcome Measures

Outcome Measure
Time Frame
white blood cell count in preoperative period
Time Frame: measured in day before operation
measured in day before operation
white blood cell count in postoperative day 1
Time Frame: measured in postoperative day 1
measured in postoperative day 1
white blood cell count in postoperative day 3
Time Frame: measured in postoperative day 3
measured in postoperative day 3
white blood cell count in postoperative day 5
Time Frame: measured in postoperative day 5
measured in postoperative day 5
white blood cell count in postoperative day 7
Time Frame: measured in postoperative day 7
measured in postoperative day 7
serum C reactive protein level in preoperative period
Time Frame: measured in day before operation
measured in day before operation
serum C reactive protein level in postoperative day 1
Time Frame: measured in postoperative day 1
measured in postoperative day 1
serum C reactive protein level in postoperative day 3
Time Frame: measured in postoperative day 3
measured in postoperative day 3
serum C reactive protein level in postoperative day 5
Time Frame: measured in postoperative day 5
measured in postoperative day 5
serum C reactive protein level in postoperative day 7
Time Frame: measured in postoperative day 7
measured in postoperative day 7
serum albumin level in preoperative period
Time Frame: measured in day before operation
measured in day before operation
serum albumin level in postoperative day 1
Time Frame: measured in postoperative day 1
measured in postoperative day 1
serum albumin level in postoperative day 3
Time Frame: measured in postoperative day 3
measured in postoperative day 3
serum albumin level in postoperative day 5
Time Frame: measured in postoperative day 5
measured in postoperative day 5
serum albumin level in postoperative day 7
Time Frame: measured in postoperative day 7
measured in postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Hyun-dong Chae, Professor, Department of Surgery, School of Medicine, Catholic University of Daegu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • APOIGC-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ileus

Clinical Trials on acupuncture

3
Subscribe