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

Study Overview
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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.

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

Conditions
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Ileus

Intervention / Treatment
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* Device: acupuncture


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remnant sitz markers in small intestine at 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 | 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 | 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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Gastric cancer