NCT00655317

Brief Summary

Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect of colon surgery. Its occurrence may lead to increased patient discomfort and additional time and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be beneficial in decreasing time to recovery of bowel function and decrease the body's inflammatory response. However, this has not been studied in a randomized, prospective fashion in colon surgery. The goal of this study is to determine if acupuncture may be utilized as a therapeutic modality to decrease time to return of bowel function and discharge from the hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

August 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

3.4 years

First QC Date

April 3, 2008

Last Update Submit

March 10, 2011

Conditions

Ileus

Keywords

acupuncturecolon surgerypost operative ileuspost ileusileuscolectomycolorectal pathology

Outcome Measures

Primary Outcomes (1)

  • Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery.

    Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery

Secondary Outcomes (3)

  • Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon

    radiological markers will be given preoperatively and then will be tracked via abdominal x-rays postoperatively

  • Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication

    number of doses of antiemetic meds and number of episodes of vomiting and nausea will be recorded postoperatively

  • Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus

    serum inflammatory markers will be measured preoperatively and postoperatively

Study Arms (2)

1

ACTIVE COMPARATOR

Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles

Other: Acupuncture

2

SHAM COMPARATOR

SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

Other: Sham acupuncture

Interventions

AcupunctureOTHER

Treatment acupuncture group: therapeutic acupuncture treatment with actual needles

1
Sham acupunctureOTHER

SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

2

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • age 18-89
  • colorectal pathology requiring standard elective open or laparoscopic colectomy

You may not qualify if:

  • pregnancy
  • pacemaker or implantable electronic devices
  • bowel obstruction
  • intra-abdominal abscess or sepsis
  • colorectal tumors invading other organs or surrounding tissues
  • diverticulitis complicated by fistula
  • known immunodeficiency disorders
  • tumors requiring an anastomosis below 7cm above the anal verge as measured by rigid proctosigmoidoscope exam at surgery
  • chronic pain medications
  • surgeries requiring temporary or permanent ostomies
  • emergent operations
  • receiving preoperative radiation/chemotherapy
  • major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupunctural treatment areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Ileus

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Philip P. Metzger, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 14, 2011

Record last verified: 2011-03

Locations

US(2)