Background: Postoperative ileus, pain, nausea and vomiting are common symptoms in patients undergoing major abdominal surgery that contribute to patient discomfort, prolonged hospital stay, readmission, postoperative morbidities and increased use of health care resources. Acupuncture, a complementary medicine modality, offers the possibility of a novel modality for these clinical problems. There exists good evidence supporting its potential value in treating all three of the most common symptoms. However, rigorously design clinical study to evaluate acupuncture in this setting is lacking. Objectives: The primary objective is to determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by a significant reduction of postoperative ileus when compared to sham acupuncture. Other objectives include 1) to evaluate whether acupuncture reduces the length of hospital stay more than sham acupuncture; 2) to explore whether acupuncture improve patient's quality of life and patient satisfaction of the hospital experience by ameliorating other postoperative symptoms such as pain, nausea and vomiting; and 3) to determine the feasibility of a phase III trial in terms of sample size, accrual rate, attrition rate and data completion Methods: In this prospective Phase II randomized, placebo-controlled, patient blinded intervention trial, colorectal cancer patients undergoing segmental or subtotal colectomy with primary anastomosis will receive acupuncture or sham acupuncture twice daily for 4 days after surgery. The primary endpoint is time to recovery of gastrointestinal function (GI-3), as defined by the later of the following two events: time that the patient first tolerated solid food, and time that the patient first passed flatus or a bowel movement. Time to discharge, pain, nausea and vomiting, and patient satisfaction with their hospitalization experience will also be evaluated. Eighty patients will be enrolled over two years. Significance: The study would help us better understand whether acupuncture can be used to help patients recover from major abdominal surgery. The research could lead to significant benefits, including 1) addition of a novel modality to our current multimodal postoperative treatment options; 2) reduction of postoperative symptoms and complications; 3) improvement of patient comfort and patient satisfaction; and 4) reduction of health care costs. ? ? ?
| Deng, Gary; Wong, W Douglas; Guillem, Jose et al. (2013) A phase II, randomized, controlled trial of acupuncture for reduction of Postcolectomy Ileus. Ann Surg Oncol 20:1164-9 |
