MedPath

Acupuncture and Post-Operative Ileus

Not Applicable
Completed
Conditions
Ileus
Interventions
Other: Acupuncture
Other: Sham acupuncture
Registration Number
NCT00655317
Lead Sponsor
Mayo Clinic
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
107
Inclusion Criteria
  • male or female
  • age 18-89
  • colorectal pathology requiring standard elective open or laparoscopic colectomy
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1AcupunctureTreatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles
2Sham acupunctureSHAM (control) acupuncture group: non-therapeutic acupuncture treatment
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colonradiological 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 medicationnumber 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 ileusserum inflammatory markers will be measured preoperatively and postoperatively

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

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