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Completed

NCT Number: NCT00655317

Acupuncture and Post-Operative Ileus

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

Treatment acupuncture group: therapeutic acupuncture treatment with actual needles

Sham Acupuncture

Other

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

Primary outcomes

  1. Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery.

    Time frame: Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery

Secondary outcomes

  1. Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon

    Time frame: radiological markers will be given preoperatively and then will be tracked via abdominal x-rays postoperatively

  2. Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication

    Time frame: number of doses of antiemetic meds and number of episodes of vomiting and nausea will be recorded postoperatively

  3. Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus

    Time frame: serum inflammatory markers will be measured preoperatively and postoperatively

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 9, 2008
Registry last updated
Mar 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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