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Acupuncture and Post-Operative Ileus
This study is enrolling participants by invitation only.
Study NCT00655317   Information provided by Mayo Clinic
First Received: April 3, 2008   Last Updated: April 8, 2008   History of Changes

April 3, 2008
April 8, 2008
August 2007
August 2010   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00655317 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Acupuncture and Post-Operative Ileus
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

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.

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
 
Interventional
Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Ileus
  • Other: Acupuncture
  • Other: Sham acupuncture
  • Active Comparator: Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles
  • Sham Comparator: SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Enrolling by invitation
107
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00655317
Philip P. Metzger, M.D., Mayo Clinic
06-009410
Mayo Clinic
 
Principal Investigator: Philip P. Metzger, M.D. Mayo Clinic
Mayo Clinic
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP