A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
- 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.
- Determine whether acupuncture reduces the length of hospital stay more than sham
- Determine whether acupuncture improves patient satisfaction with the hospital
experience by ameliorating other postoperative symptoms, such as pain, nausea, and
- 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.
Allocation: Randomized, Primary Purpose: Supportive Care
Time to recovery of gastrointestinal (GI) function (GI-3), as defined by the time the patient first tolerates solid food, or the time the patient first passes flatus or has a bowel movement, whichever occurs later
Gary E. Deng, MD, PhD
Memorial Sloan-Kettering Cancer Center
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|