- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480361
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
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
Keywords
Additional Relevant MeSH Terms
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
-
Assiut UniversityRecruitingPostoperative IleusEgypt
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Ileus | Gynecologic Disease | Paralytic IleusTurkey
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenRecruitingPostoperative IleusBelgium
-
West China HospitalCompletedPostoperative IleusChina
-
Hadassah Medical OrganizationCompleted
-
li xiongUnknown
-
Jinling Hospital, ChinaCompletedPostoperative IleusChina
-
Services Hospital, LahoreCompletedPostoperative IleusPakistan
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenCompletedPostoperative IleusBelgium
-
Gabriele Baldini, MD, MSc, Assistant ProfessorCompleted
Clinical Trials on acupuncture
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
Federal University of São PauloCompleted
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown
-
Chengdu University of Traditional Chinese MedicineChongqing Medical University; Hunan University of Traditional Chinese MedicineCompletedFunctional Dyspepsia | Postprandial Distress SyndromeChina
-
University of MichiganMassachusetts General Hospital; National Center for Complementary and Integrative...Completed
-
University Medicine GreifswaldRecruitingGagging During Transesophageal EchocardiographyGermany
-
Chang Gung Memorial HospitalRecruitingIntracranial HemorrhagesTaiwan
-
Huazhong University of Science and TechnologyThe University of Hong Kong; Heilongjiang University of Chinese Medicine; Hubei...CompletedPolycystic Ovary SyndromeChina
-
China Medical University HospitalNot yet recruiting