Trial of Acupuncture for Reduction of Post-Colectomy Ileus

Completed · Phase 2 · Has a placebo group

Conditions studied: Postoperative Ileus, Colon Cancer, Pain, Postoperative, Postoperative Nausea and Vomiting

In brief

The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.

Key facts

Study ID

NCT00402961

Run by

Memorial Sloan Kettering Cancer Center

People needed

90

Starts

2006-10-01

Expected to finish

2013-02-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women of any ethnicity
• Age over 18 years (children are not included because colorectal cancer is rare in children).
• Scheduled to undergo elective resection of biopsy proven colorectal cancer or suspected colorectal cancer

You may not qualify if…

• Pre-operative factors:
• History of major abdominal or pelvic surgery that have caused significant alteration in anatomy and function of the GI tract which may affect the endpoints of this study.
• Laparoscopic procedures. They tend to result in less postoperative ileus.
• Administration of epidural anesthetics or epidural opioids: these have previously been shown to affect postoperative GI motility. They made up only 5% of colectomy patients in the investigators' institution.
• Acupuncture within the last 4 weeks (to exclude any possible residual effect from acupuncture)
• Contraindications to use of electrical stimulation, including cardiac pacemaker and implantable cardioverter defibrillator (ICD)
• Prior serious adverse event with acupuncture
• Intra-operative events (these events alter the postoperative recovery course significantly):
• Resection incorporating the upper GI tract. Such surgeries are usually more complex, involving more organs and are associated with a more diverse postoperative course, making the study population more heterogeneous.
• Gross fecal spillage (high complication rate in this setting)
• Need to leave nasogastric tube in (contaminating the primary endpoint)
• Decision to give epidural anesthetics or epidural opioids postoperatively (shown previously to change the major endpoints)
• Complications during surgery requiring a patient to be transferred to the Intensive Care Unit (ICU) directly from the Operating Room or Post Anesthesia Care Unit (PACU) as this also alters the postoperative course significantly. Patients transferred to the floor first will not be excluded. They will be fully registered and randomized. If they deteriorate later during the hospital stay, requiring a transfer to the ICU, they will still be followed.

Where it is running

• Memorial Sloan-Kettering Cancer Center 1275 York Avenue — New York, New York, United States

Full record on ClinicalTrials.gov

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