Status:
COMPLETED
Trial of Acupuncture for Reduction of Post-Colectomy Ileus
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Postoperative Ileus
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.
Detailed Description
* To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence of reduction of postoperative ileus when compared to sha...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00402961
Start Date
October 1 2006
End Date
February 1 2013
Last Update
October 12 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10021