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Acupuncture and Post-Operative Ileus

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Mayo Clinic

Status

Completed

Conditions

Ileus

Treatments

Other: Sham acupuncture
Other: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT00655317
06-009410

Details and patient eligibility

About

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.

Full 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

Enrollment

107 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

107 participants in 2 patient groups

1
Active Comparator group
Description:
Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles
Treatment:
Other: Acupuncture
2
Sham Comparator group
Description:
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
Treatment:
Other: Sham acupuncture

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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