Acupuncture and Post-Operative Ileus

NCT ID: NCT00655317

Last Updated: 2011-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-01-31

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

Conditions

Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: OTHER

Treatment acupuncture group: therapeutic acupuncture treatment with actual needles

2

SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: OTHER

SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

Interventions

Acupuncture

Treatment acupuncture group: therapeutic acupuncture treatment with actual needles

Intervention Type: OTHER

Sham acupuncture

SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Philip P. Metzger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

06-009410

Identifier Type: -

Identifier Source: org_study_id