Acupuncture and Post-Operative Ileus

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00655317
First received: April 3, 2008
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Ileus
Other: Acupuncture
Other: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Acupuncture and Post-Operative Ileus: A Prospective Randomized Study to Evaluate the Effects of Electrostimulated Acupuncture on Recovery From Ileus Following Standard Elective Colon Surgery

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery. [ Time Frame: Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon [ Time Frame: radiological markers will be given preoperatively and then will be tracked via abdominal x-rays postoperatively ] [ Designated as safety issue: Yes ]
  • Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication [ Time Frame: number of doses of antiemetic meds and number of episodes of vomiting and nausea will be recorded postoperatively ] [ Designated as safety issue: Yes ]
  • Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus [ Time Frame: serum inflammatory markers will be measured preoperatively and postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 107
Study Start Date: August 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles
Other: Acupuncture
Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
Other Name: Acupuncture
Sham Comparator: 2
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
Other: Sham acupuncture
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

Detailed Description:

The pathogenesis of post-operative ileus is not completely known. It is thought that post-operative ileus involves trauma to the bowel. This traumatizing of the intestine and peritoneal surfaces results in production and release of inflammatory mediators. These in turn, lead to inactivation of inhibitory neural reflexes. There is also an additive effect of opioids used for post-operative pain, aggravating and adding to the duration of post-operative ileus. Acupuncture has shown promise in both human and animal model studies to reduce post-operative nausea and vomiting and post-operative ileus. It is the investigator's hypothesis that acupuncture will minimize or reduce both post-operative ileus and nausea following elective colon surgery and will lead to a decrease in inflammatory markers that are known to be elevated following abdominal surgery.

The study goals are to determine if acupuncture:

  • Leads to earlier return of bowel function
  • Leads to earlier time to discharge following colon surgery
  • Leads to earlier return of colonic motility
  • Leads to decreased postoperative nausea and vomiting
  • Leads to a decrease in inflammation
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655317

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Philip P. Metzger, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Philip P. Metzger, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00655317     History of Changes
Other Study ID Numbers: 06-009410
Study First Received: April 3, 2008
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
acupuncture
colon surgery
post operative ileus
post ileus
ileus
colectomy
colorectal pathology

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014