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.

Study Overview

• Status: Completed
• Conditions: Ileus
• Intervention / Treatment: Other: Acupuncture; Other: Sham acupuncture

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Sham Comparator: 2; SHAM (control) acupuncture group: non-therapeutic acupuncture treatment	Other: Sham acupuncture; SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery.	Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon	radiological markers will be given preoperatively and then will be tracked via abdominal x-rays postoperatively
Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication	number of doses of antiemetic meds and number of episodes of vomiting and nausea will be recorded postoperatively
Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus	serum inflammatory markers will be measured preoperatively and postoperatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Philip P. Metzger, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): March 14, 2011
• Last Update Submitted That Met QC Criteria: March 10, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: acupuncture; colon surgery; post operative ileus; post ileus; ileus; colectomy; colorectal pathology
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: 06-009410