Acupuncture to aid post-colectomy recovery in colorectal cancer patients

针灸有助于结直肠癌患者结肠切除术后的恢复

• 批准号: 7282743
• 负责人: GARY E DENG
• 金额: $ 20.48万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7282743
• 关键词: Abdomen; Acupuncture procedure; Adverse event; Anastomosis - action; Blinded; Cancer Patient; Caring; Client satisfaction; Clinical; Clinical Research; Colectomy; Colorectal Cancer; Colorectal Surgery; Complementary Medicine; Daily; Data; Defecation; Development; Effectiveness; End Point; Enrollment; Event; Flatulence; Food; Health Care Costs; Healthcare; Hospitalization; Hospitals; Ileus; Intake; Intervention Trial; Lead; Length of Stay; Methods; Modality; Morbidity - disease rate; Nausea and Vomiting; Operative Surgical Procedures; Opioid; Oral; Pain; Patients; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Placebo Control; Placebos; Population Study; Postoperative Nausea and Vomiting; Postoperative Pain; Postoperative Period; Quality of life; Randomized; Rate; Recovery; Research; Research Project Grants; Resources; Safety; Sample Size; Solid; Standards of Weights and Measures; Surgeon; Symptoms; Time; cell motility; cost; day; design; experience; gastrointestinal; gastrointestinal function; improved; novel; prospective

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.

描述（由申请人提供）：背景：术后肠梗阻、疼痛、恶心和呕吐是接受腹部大手术的患者的常见症状，会导致患者不适、住院时间延长、再入院、术后发病率和医疗保健资源使用增加。针灸作为一种辅助医学，为这些临床问题提供了一种新的治疗方式。有很好的证据支持它在治疗所有三种最常见症状方面的潜在价值。然而，缺乏严格设计的临床研究来评估针灸在这种情况下的作用。目的：主要目标是确定是否需要进行针灸用于结直肠手术后术后恢复的III期试验，其定义是与假针灸相比，术后肠梗阻显着减少。其他目的包括1）评估针灸是否比假针灸更能缩短住院时间; 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住院经历的满意度; 3）从样本量、累积率、脱落率和数据完整性等方面确定III期试验的可行性。在这项前瞻性II期随机、安慰剂对照、患者盲法干预试验中，接受节段性或次全结肠切除术并进行一期吻合术的结直肠癌患者将在术后接受针灸或假针灸治疗，每日两次，持续4天。主要终点是至胃肠道功能恢复的时间（GI-3），由以下两个事件中的较晚事件定义：患者首次耐受固体食物的时间和患者首次排气或排便的时间。还将评价出院时间、疼痛、恶心和呕吐以及患者对其住院经历的满意度。将在2年内入组80例患者。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腹部大手术中恢复。该研究可能会带来显著的益处，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）改善患者舒适度和患者满意度; 4）降低医疗保健成本。

项目成果

A phase II, randomized, controlled trial of acupuncture for reduction of Postcolectomy Ileus.

• DOI: 10.1245/s10434-012-2759-7
• 发表时间: 2013-04
• 期刊: Annals of surgical oncology
• 影响因子: 3.7
• 作者: Deng G;Wong WD;Guillem J;Chan Y;Affuso T;Yeung KS;Coleton M;Sjoberg D;Vickers A;Cassileth B
• 通讯作者: Cassileth B