Pain, Postoperative Clinical Trial
Official title:
A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.
Status | Completed |
Enrollment | 90 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center 1275 York Avenue | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 sham acupuncture | end of study | No | |
Secondary | To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting | daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay. | No | |
Secondary | To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion | end of study | No | |
Secondary | GI-2, (also representing time to recovery of gastrointestinal [GI] function) | patient first tolerated solid food,and time patient first passed a bowel movement | No | |
Secondary | GI contractions measured with a multifunctional stethoscope | duration of two minute before and immediately after each true or sham acupuncture treatment. | No | |
Secondary | Daily pain score | daily during hospitalization | No | |
Secondary | Opioid consumption (total dose of morphine equivalent during hospitalization and average dose per day) | daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay. | No | |
Secondary | Number of emetic episodes during hospital stay | assement daily | No |
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