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

Primary Purpose

Ileus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Daegu Catholic University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ileus focused on measuring Acupuncture, Gastric cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Acupuncture

    Non-acupuncture

    Arm Description

    The patients who were received acupuncture after gastric cancer surgery

    The patients who were not received acupuncture after gastric cancer surgery

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Time to first flatus
    start of water intake
    start of soft diet
    hospital stay

    Full Information

    First Posted
    June 9, 2015
    Last Updated
    June 22, 2015
    Sponsor
    Daegu Catholic University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02480361
    Brief Title
    Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)
    Acronym
    EAPIG
    Official Title
    Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Daegu Catholic University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ileus
    Keywords
    Acupuncture, Gastric cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Experimental
    Arm Description
    The patients who were received acupuncture after gastric cancer surgery
    Arm Title
    Non-acupuncture
    Arm Type
    No Intervention
    Arm Description
    The patients who were not received acupuncture after gastric cancer surgery
    Intervention Type
    Device
    Intervention Name(s)
    acupuncture
    Intervention Description
    Acupuncture treatment after gastric cancer surgery during 5 postoperative days
    Primary Outcome Measure Information:
    Title
    Remnant sitz markers in small intestine at postoperative day 1
    Description
    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.
    Time Frame
    measured in postoperative day 1
    Title
    Remnant sitz markers in small intestine at postoperative day 3
    Description
    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.
    Time Frame
    measured in postoperative day 3
    Title
    Remnant sitz markers in small intestine at postoperative day 5
    Description
    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.
    Time Frame
    measured in postoperative day 5
    Title
    Remnant sitz markers in small intestine at postoperative day 7
    Description
    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.
    Time Frame
    measured in postoperative day 7
    Secondary Outcome Measure Information:
    Title
    Time to first flatus
    Time Frame
    up to 5 dyas
    Title
    start of water intake
    Time Frame
    up to 7days
    Title
    start of soft diet
    Time Frame
    up to 7days
    Title
    hospital stay
    Time Frame
    up to 2 weeks
    Other Pre-specified Outcome Measures:
    Title
    white blood cell count in preoperative period
    Time Frame
    measured in day before operation
    Title
    white blood cell count in postoperative day 1
    Time Frame
    measured in postoperative day 1
    Title
    white blood cell count in postoperative day 3
    Time Frame
    measured in postoperative day 3
    Title
    white blood cell count in postoperative day 5
    Time Frame
    measured in postoperative day 5
    Title
    white blood cell count in postoperative day 7
    Time Frame
    measured in postoperative day 7
    Title
    serum C reactive protein level in preoperative period
    Time Frame
    measured in day before operation
    Title
    serum C reactive protein level in postoperative day 1
    Time Frame
    measured in postoperative day 1
    Title
    serum C reactive protein level in postoperative day 3
    Time Frame
    measured in postoperative day 3
    Title
    serum C reactive protein level in postoperative day 5
    Time Frame
    measured in postoperative day 5
    Title
    serum C reactive protein level in postoperative day 7
    Time Frame
    measured in postoperative day 7
    Title
    serum albumin level in preoperative period
    Time Frame
    measured in day before operation
    Title
    serum albumin level in postoperative day 1
    Time Frame
    measured in postoperative day 1
    Title
    serum albumin level in postoperative day 3
    Time Frame
    measured in postoperative day 3
    Title
    serum albumin level in postoperative day 5
    Time Frame
    measured in postoperative day 5
    Title
    serum albumin level in postoperative day 7
    Time Frame
    measured in postoperative day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyun-dong Chae, Professor
    Organizational Affiliation
    Department of Surgery, School of Medicine, Catholic University of Daegu
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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