Clinical Trial: Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study
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 Summary: 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.
Sponsor: Daegu Catholic University Medical Center
Current Primary Outcome:
- 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.
- 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.
- 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.
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to first flatus [ Time Frame: up to 5 dyas ]
- start of water intake [ Time Frame: up to 7days ]
- start of soft diet [ Time Frame: up to 7days ]
- hospital stay [ Time Frame: up to 2 weeks ]
Original Secondary Outcome: Same as current
Information By: Daegu Catholic University Medical Center
Dates:
Date Received: June 9, 2015
Date Started: January 2013
Date Completion:
Last Updated: June 22, 2015
Last Verified: June 2015