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

Ileus Clinical Trial

— EAPIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480361
• Other study ID #: APOIGC-13
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: June 22, 2015
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ileus

Intervention

Device:
• acupuncture
Acupuncture treatment after gastric cancer surgery during 5 postoperative days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	white blood cell count in preoperative period		measured in day before operation	No
Other	white blood cell count in postoperative day 1		measured in postoperative day 1	No
Other	white blood cell count in postoperative day 3		measured in postoperative day 3	No
Other	white blood cell count in postoperative day 5		measured in postoperative day 5	No
Other	white blood cell count in postoperative day 7		measured in postoperative day 7	No
Other	serum C reactive protein level in preoperative period		measured in day before operation	No
Other	serum C reactive protein level in postoperative day 1		measured in postoperative day 1	No
Other	serum C reactive protein level in postoperative day 3		measured in postoperative day 3	No
Other	serum C reactive protein level in postoperative day 5		measured in postoperative day 5	No
Other	serum C reactive protein level in postoperative day 7		measured in postoperative day 7	No
Other	serum albumin level in preoperative period		measured in day before operation	No
Other	serum albumin level in postoperative day 1		measured in postoperative day 1	No
Other	serum albumin level in postoperative day 3		measured in postoperative day 3	No
Other	serum albumin level in postoperative day 5		measured in postoperative day 5	No
Other	serum albumin level in postoperative day 7		measured in postoperative day 7	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Time to first flatus		up to 5 dyas	No
Secondary	start of water intake		up to 7days	No
Secondary	start of soft diet		up to 7days	No
Secondary	hospital stay		up to 2 weeks	No