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NCT Number: NCT02480361

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

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.

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Key information

Conditions

Ileus Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Obstruction Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

Acupuncture treatment after gastric cancer surgery during 5 postoperative days

Primary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

Secondary outcomes

  1. Time to first flatus

    Time frame: up to 5 dyas

  2. start of water intake

    Time frame: up to 7days

  3. start of soft diet

    Time frame: up to 7days

  4. hospital stay

    Time frame: up to 2 weeks

Other outcomes

  1. white blood cell count in preoperative period

    Time frame: measured in day before operation

  2. white blood cell count in postoperative day 1

    Time frame: measured in postoperative day 1

  3. white blood cell count in postoperative day 3

    Time frame: measured in postoperative day 3

  4. white blood cell count in postoperative day 5

    Time frame: measured in postoperative day 5

  5. white blood cell count in postoperative day 7

    Time frame: measured in postoperative day 7

  6. serum C reactive protein level in preoperative period

    Time frame: measured in day before operation

  7. serum C reactive protein level in postoperative day 1

    Time frame: measured in postoperative day 1

  8. serum C reactive protein level in postoperative day 3

    Time frame: measured in postoperative day 3

  9. serum C reactive protein level in postoperative day 5

    Time frame: measured in postoperative day 5

  10. serum C reactive protein level in postoperative day 7

    Time frame: measured in postoperative day 7

  11. serum albumin level in preoperative period

    Time frame: measured in day before operation

  12. serum albumin level in postoperative day 1

    Time frame: measured in postoperative day 1

  13. serum albumin level in postoperative day 3

    Time frame: measured in postoperative day 3

  14. serum albumin level in postoperative day 5

    Time frame: measured in postoperative day 5

  15. serum albumin level in postoperative day 7

    Time frame: measured in postoperative day 7

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

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

Acronym: EAPIG

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 24, 2015
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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