NCT02480361

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

June 9, 2015

Last Update Submit

June 22, 2015

Conditions

Ileus

Keywords

AcupunctureGastric cancer

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (4)

  • Time to first flatus

    up to 5 dyas

  • start of water intake

    up to 7days

  • start of soft diet

    up to 7days

  • hospital stay

    up to 2 weeks

Other Outcomes (15)

  • white blood cell count in preoperative period

    measured in day before operation

  • white blood cell count in postoperative day 1

    measured in postoperative day 1

  • white blood cell count in postoperative day 3

    measured in postoperative day 3

  • +12 more other outcomes

Study Arms (2)

Acupuncture

EXPERIMENTAL

The patients who were received acupuncture after gastric cancer surgery

Device: acupuncture

Non-acupuncture

NO INTERVENTION

The patients who were not received acupuncture after gastric cancer surgery

Interventions

acupunctureDEVICE

Acupuncture treatment after gastric cancer surgery during 5 postoperative days

Acupuncture

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective surgery for gastric cancers
  • Patients with American Society of Anesthesiologists grades I-III
  • Patients who provided written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

IleusStomach Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsStomach Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Hyun-dong Chae, Professor

    Department of Surgery, School of Medicine, Catholic University of Daegu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 24, 2015

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 24, 2015

Record last verified: 2015-06