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| Descriptive Information Fields | |||||
| Brief Title † | Acupuncture and Post-Operative Ileus | ||||
| 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 | ||||
| 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. |
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| 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:
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | 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 Measure † | 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 ] |
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| Condition † | Ileus | ||||
| Intervention † | Other: Acupuncture Other: Sham acupuncture |
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| MEDLINE PMIDs | |||||
| Links | Mayo Clinic Clinical Trials ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 107 | ||||
| Start Date † | August 2007 | ||||
| Completion Date | August 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 89 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00655317 | ||||
| Organization ID | 06-009410 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Mayo Clinic | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 3, 2008 | ||||
| Last Updated Date | April 8, 2008 | ||||