IleusEAPIGNCT02480361
Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)
A study testing acupuncture in people with Ileus, run by Daegu Catholic University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileus
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective surgery for gastric cancers
- Patients with American Society of Anesthesiologists grades I-III
- Patients who provided written informed consent
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Ileus
- Being tested
- acupuncture
- Keywords
- Acupuncture, Gastric cancer
- Medical subject headings
- Ileus, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Acupuncture treatment after gastric cancer surgery during 5 postoperative days
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | The patients who were received acupuncture after gastric cancer surgery Receives: Device: acupuncture |
| Non-acupuncture | No intervention | The patients who were not received acupuncture after gastric cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: measured in postoperative day 7
Secondary outcomes (4)
Time to first flatus
Measured: up to 5 dyas
start of water intake
Measured: up to 7days
start of soft diet
Measured: up to 7days
hospital stay
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hwan Kim, Daegu Catholic University Medical Center
- Investigators
- Hyun-dong Chae, Professor, Study director, Department of Surgery, School of Medicine, Catholic University of Daegu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480361
- Sponsor's protocol ID
- APOIGC-13
- Acronym
- EAPIG
- Status last verified
- Jun 2015
- First submitted
- 9 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02480361
- Acronym / sponsor ID
- EAPIG / APOIGC-13
- Conditions
- Ileus
- Keywords
- Acupuncture, Gastric cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: acupunctureThe patients who were received acupuncture after gastric cancer surgery |
| Non-acupuncture | No intervention | –The patients who were not received acupuncture after gastric cancer surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective surgery for gastric cancers
- Patients with American Society of Anesthesiologists grades I-III
- Patients who provided written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAcupuncture treatment after gastric cancer surgery during 5 postoperative days | Device | Acupuncture |
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun-dong Chae, Professor study director
Department of Surgery, School of Medicine, Catholic University of Daegu
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Ileus, run by Daegu Catholic University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remnant sitz markers in small intestine at postoperative day 1 (time frame: measured in postoperative day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.