Acupuncture and Post-Operative Ileus
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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 |
- 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 ]
- 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 |
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| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| 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 May 23, 2013