Acupuncture to aid post-colectomy recovery in colorectal cancer patients

描述(申请人提供)：背景：术后肠梗阻、疼痛、恶心和呕吐是腹部大手术患者的常见症状，这些症状会导致患者不适、住院时间延长、再次住院、术后并发症和增加医疗资源的使用。针灸是一种补充医学模式，为这些临床问题提供了一种新的模式的可能性。有很好的证据支持它在治疗这三种最常见的症状方面的潜在价值。然而，在这种情况下，缺乏严格设计的临床研究来评估针灸。目的：主要目的是确定针灸对结直肠手术后术后恢复的第三阶段试验是否有根据：与假针灸相比，术后肠梗阻的显着减少。其他目标包括1)评估针灸是否比假针灸更能减少住院时间；2)探讨针灸是否通过改善其他术后症状，如疼痛、恶心和呕吐来改善患者的生活质量和患者对医院体验的满意度；3)从样本量、发生率、流失率和资料完成率方面确定III期试验的可行性：在这项前瞻性的II期随机、安慰剂对照的患者盲目干预试验中，接受分段或次全结肠切除并一期吻合的结直肠癌患者将在术后4天内每天接受针灸或假针灸治疗两次。主要终点是胃肠功能恢复的时间(GI-3)，由以下两个事件中的较晚者定义：患者首次耐受固体食物的时间，以及患者首次排气或排便的时间。还将评估患者的出院时间、疼痛、恶心和呕吐，以及患者对其住院经历的满意度。80名患者将在两年内入选。意义：这项研究将帮助我们更好地了解针灸是否可以用来帮助患者从大的腹部手术中恢复。这项研究可能会带来显著的好处，包括1)为我们目前的多模式术后治疗选择增加一种新的模式；2)减少术后症状和并发症；3)改善患者的舒适度和患者满意度；以及4)降低医疗成本。

DESCRIPTION (provided by applicant): 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.