Acupuncture and Post-Operative Ileus - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00655317

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

MedlinePlus related topics: Acupuncture Nausea and Vomiting Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	107
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles	Other: Acupuncture Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
2: Sham Comparator 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

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

Locations

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Philip P. Metzger, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Philip P. Metzger, M.D. )
Study ID Numbers:	06-009410
Study First Received:	April 3, 2008
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00655317 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

acupuncture
colon surgery
post operative ileus
post ileus

ileus
colectomy
colon surgery
colorectal pathology

Study placed in the following topic categories:

Intestinal Obstruction
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Additional relevant MeSH terms:

Intestinal Obstruction
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009