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

Not Applicable

Completed

• Conditions: Ileus
• Interventions: Device: acupuncture

• Registration Number: NCT02480361
• Lead Sponsor: Daegu Catholic University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-06
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Study First Posted: 2015-06-24
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	acupuncture	The patients who were received acupuncture after gastric cancer surgery

Primary Outcome Measures

Name	Time	Method
Remnant sitz markers in small intestine at postoperative day 3	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.
Remnant sitz markers in small intestine at postoperative day 1	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.
Remnant sitz markers in small intestine at postoperative day 5	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.
Remnant sitz markers in small intestine at postoperative day 7	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.

Secondary Outcome Measures

Name	Time	Method
Time to first flatus	up to 5 dyas
start of water intake	up to 7days
start of soft diet	up to 7days
hospital stay	up to 2 weeks