View Clinical Trial (Medical Research Study)
A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10065 |
| Conditions: |
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Colorectal Cancer - Gastrointestinal Complications - Nausea and Vomiting - Pain - Perioperative/Postoperative Complications |
| Purpose: |
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RATIONALE: Acupuncture may help lessen ileus caused by colon surgery.
PURPOSE: This randomized phase II trial is studying acupuncture to see how well it reduces
ileus compared with sham acupuncture in patients who have undergone surgery for colorectal
cancer.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine whether a phase III study of acupuncture for postoperative recovery after
colorectal surgery is warranted, as defined by evidence of reduction of postoperative
ileus in patients who undergo acupuncture vs sham acupuncture after segmental or
subtotal colectomy with primary anastomosis for colorectal cancer.
Secondary
- Determine whether acupuncture reduces the length of hospital stay more than sham
acupuncture.
- Determine whether acupuncture improves patient satisfaction with the hospital
experience by ameliorating other postoperative symptoms, such as pain, nausea, and
vomiting.
- Determine the feasibility of a phase III trial, in terms of sample size, accrual rate,
attrition rate, and data completion.
OUTLINE: This is a randomized, prospective, placebo-controlled study. Patients are
stratified according to type of colectomy (segmental vs subtotal). Patients are randomized
to 1 of 2 treatment arms.
- Arm I (acupuncture): Patients undergo acupuncture over 30 minutes twice daily on days
1-3 after surgery. Electrical stimulation is applied to 2 pairs of acupuncture points.
- Arm II (sham acupuncture): Patients undergo sham acupuncture over 30 minutes twice
daily on days 1-3 after surgery.
Bowel function, pain, and nausea and vomiting are assessed daily until hospital discharge.
Patients complete two treatment-related questionnaires after completion of study therapy.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed or suspected colorectal cancer
- Has undergone elective segmental or subtotal colectomy with primary anastomosis
- No requirement for ileostomy or colostomy
- No resection incorporating the upper gastrointestinal tract
- No gross fecal spillage
- No complications during surgery requiring a patient's transfer to the Intensive
Care Unit (ICU) directly from the operating room or Post Anesthesia Care Unit
(PACU)
- Patients who are transferred to the floor first and who subsequently
require transfer to ICU are eligible
- No requirement for leaving the intraoperative nasogastric tube in place
- No postoperative epidural anesthetics or epidural opioids
PATIENT CHARACTERISTICS:
- No prior serious adverse event with acupuncture
- No contraindication to use of electrical stimulation, including cardiac pacemaker and
implantable cardioverter defibrillator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior major abdominal or pelvic surgery
- Prior uncomplicated appendectomy, cholecystectomy, or hysterectomy performed
more than 3 years ago allowed
- No prior laparoscopic procedure
- No acupuncture within the past 4 weeks
- No concurrent epidural anesthetics or epidural opioids
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| NCT ID: |
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NCT00425412 |
| Primary Contact: |
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Principal Investigator
Gary E. Deng, MD, PhD
Memorial Sloan-Kettering Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10065
United States
Gary E. Deng, MD, PhD
Phone: 212-639-4956
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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