A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
- 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.
- To explore whether acupuncture reduces the length of hospital stay more than sham
acupuncture
- To explore whether acupuncture improves patient satisfaction with the hospital
experience by ameliorating other postoperative symptoms such as pain and nausea and
vomiting.
- To determine the feasibility of a Phase III trial in terms of sample size, accrual
rate, attrition rate and data completion.
Postoperative ileus contributes to prolonged hospital stay, readmission and postoperative
morbidities in patients undergoing major abdominal surgery. Reduction of postoperative ileus
is important in postoperative recovery. Postoperative pain may require opioids, which
further reduce gastrointestinal (GI) motility. Postoperative nausea and vomiting hamper the
resumption of oral intake. Together, these three common postoperative problems contribute to
patient discomfort, delayed discharge and increased overall hospitalization costs, despite
current multi-modal management options. Any safe and effective therapy in addition to
current standard of care would be welcomed by patients, surgeons and hospitals.
Acupuncture is a complementary medicine modality shown to reduce postoperative pain,
suppress nausea and vomiting, and promote GI motility. It is associated with few adverse
events. Here we propose a randomized, sham controlled phase II study to evaluate
acupuncture, in addition to conventional therapy, for its safety and effectiveness in
improving postoperative recovery of colorectal cancer patients undergoing segmental or
subtotal colectomy. The overall objective of this developmental project is to determine
whether a more extended research project is warranted.
The specific aims are:
- To determine whether a Phase III trial of acupuncture for postoperative recovery after
colorectal surgery is warranted as defined by evidence for a reduction of postoperative
ileus when compared to sham acupuncture. Hypothesis: acupuncture promotes upper and
lower GI motility in patients experiencing postoperative ileus after colectomy more
than sham acupuncture.
- To explore whether acupuncture improves patient satisfaction with the hospital
experience by ameliorating other postoperative symptoms such as pain and nausea and
vomiting. Hypothesis 2a: acupuncture reduces postoperative pain more than placebo in
colectomy patients; 2b: acupuncture reduces postoperative nausea and vomiting more than
placebo in colectomy patients.
- To determine the feasibility of a phase III trial in terms of sample size, accrual
rate, attrition rate and data completion. Hypothesis 3: a phase III study of
acupuncture in the treatment of post-colectomy ileus in cancer patients is feasible.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Gary Deng, MD, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
06-145
NCT00402961
November 2006
February 2013
Name | Location |
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Memorial Sloan-Kettering Cancer Center 1275 York Avenue | New York, New York 10021 |