ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Acupuncture and Post-Operative Ileus

This study is enrolling participants by invitation only.
Study NCT00655317.   Last updated on April 8, 2008.   Information provided by Mayo Clinic

This Tabular View shows the required WHO registration data elements as marked by

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.

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
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 ]
Condition  Ileus
Intervention  Other: Acupuncture
Other: Sham acupuncture
MEDLINE PMIDs
Links Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Enrolling by invitation
Enrollment  107
Start Date  August 2007
Completion Date August 2010
Eligibility 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
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 
Principal Investigator:     Philip P. Metzger, M.D.     Mayo Clinic    
Information Provided By Mayo Clinic
Verification Date April 2008
First Received Date  April 3, 2008
Last Updated Date April 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers