Acupuncture and Post-Operative Ileus

Ileus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655317
• Other study ID #: 06-009410
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: March 10, 2011
• Start date: August 2007
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ileus

Intervention

Other:
• Acupuncture
Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
• Sham acupuncture
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus		serum inflammatory markers will be measured preoperatively and postoperatively	Yes

External Links

•   Mayo Clinic Clinical Trials