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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00655317 |
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 |
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Ileus |
Other: Acupuncture Other: Sham acupuncture |
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 |
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 |
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1: Active Comparator
Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles
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Other: Acupuncture
Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
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2: Sham Comparator
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
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Other: Sham acupuncture
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
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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:
Ages Eligible for Study: | 18 Years to 89 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
acupuncture colon surgery post operative ileus post ileus |
ileus colectomy colon surgery colorectal pathology |
Intestinal Obstruction Ileus Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Intestinal Obstruction Ileus Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |