Acupuncture and Post-Operative Ileus

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00655317

Collaborator

(none)

107

Enrollment

Locations

Arms

Duration (Months)

53.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ileus	Other: Acupuncture Other: Sham acupuncture	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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