PHASE III TRIAL--LAPAROSCOPIC COLECTOMY FOR COLON CANCER

III期试验——腹腔镜结肠癌结肠切除术

• 批准号: 2107975
• 负责人: HEIDI NELSON
• 金额: $ 52.5万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-09 至 1997-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2107975
• 关键词: clinical trials; colon surgery; cooperative study; functional ability; health care cost /financing; hospital length of stay; human mortality; human subject; human therapy evaluation; neoplasm /cancer classification /staging; neoplasm /cancer surgery; postoperative complications; quality of life; sign /symptom

Despite many important medical advances, surgery remains the primary treatment modality for the majority of the 109,000 individuals who are newly diagnosed with colon cancer each year. Surgery not only provides extirpation of the primary tumor which relieves symptoms and prevents complications, but in addition provides important staging information. Although oncologic results from open colectomy are well-established, these traditional resective and staging techniques are challenged by the introduction of minimal access surgery. Laparoscopic cholecystectomy, an example of minimal access resective surgery has rapidly become the preferred surgical approach to cholelithiasis, due to significant reductions in recovery time, disabilities, and costs. It has been proposed that minimal access surgery of the colon may offer similar advantages. Minimally invasive resections of the colon can be performed using laparoscopic techniques to ligate vasculature, mobilize and exteriorize bowel, and extracorporeal techniques to resect and anastomose bowel. Collective preliminary data from a consortium of experienced laparoscopic surgeons supports that laparoscopic-assisted colectomy is safe, feasible, and reduces recovery times, disabilities, and costs. To date rigorous quality of life and cost analyses have not been performed and further concern has been raised regarding the adequacy of this technique for staging and treatment of colon cancer, a common indication for colectomy. A prospective randomized trial accruing 1,200 patients over three years is proposed to address three SPECIFIC AIMS, The PRIMARY AIM of the study is to test the hypothesis that disease-free survival and overall survival are equivalent regardless of whether patients receive laparoscopic assisted or open colectomy. If a significant adverse affect on cancer outcome is detected, then no further analyses will be recommended. If, however, laparoscopic-assisted colectomy does not adversely affect disease-free or overall survival then further aims will be tested. The SECONDARY AIM of the study is to determine the safety of laparoscopic-assisted colectomy compared to open colectomy, specifically with the respect to operative morbidities and mortality. The TERTIARY AIM of the study is to test the hypothesis that laparoscopic-assisted colectomy is a cost effective alternative to open colectomy and results in superior quality of life. Measurable end points for the quality of life will include symptoms, functional status and utilities, and early and late surgical complications. Measurable end points for cost will include resource utilization for all institutions and actual cost for two institutions. To insure an efficient, successful, high-quality study, an intergroup mechanism will be used to conduct the trial. Although surgical participation will be limited to surgeons who demonstrate expertise in laparoscopic colon surgery, the diverse geographic locations and practice environments of the participating institutions is intended to maximize diversity and the application of the results to the general community.

尽管有许多重要的医疗进展，但手术仍然是主要的 109,000个人中的大多数的治疗方式 每年新诊断出患有结肠癌。手术不仅提供 消除原发性肿瘤，可缓解症状并防止症状 并发症，但此外还提供了重要的分期信息。 尽管开放式结肠切除术的肿瘤学结果是良好的，但 传统的转让和分期技术受到挑战 引入最少的访问手术。腹腔镜胆囊切除术，An 最小访问锻炼手术的例子已迅速成为 由于明显的 减少恢复时间，残疾和成本。已经提出了 结肠的最低访问手术可能具有类似的优势。 可以使用最小的结肠侵入性切除术 腹腔镜技术结合脉管系统，动员和外部 排便和外体外技术以切除和吻合的肠道。 来自经验丰富的腹腔镜联盟的集体初步数据 外科医生支持腹腔镜辅助结肠切除术是安全的，可行的， 并减少恢复时间，残疾和成本。迄今为止严格 生活质量和成本分析尚未进行，进一步进行 人们对此技术的适当性提出了关注 结肠癌的分期和治疗，是结肠切除术的常见指示。 一项预期的随机试验在三年内累积了1200名患者 提议解决三个具体目标，该研究的主要目的是 为了测试无病生存和整体生存的假设是 不管患者是否获得腹腔镜辅助或 开放结肠切除术。如果对癌症结果产生重大不利影响是 检测到，不建议进一步分析。但是，如果 腹腔镜辅助结肠切除术不会对无病或 总体生存将测试进一步的目标。次要目标 该研究是为了确定腹腔镜辅助结肠切除术的安全性 与开放式结肠切除术相比，特别是对手术的 病态和死亡率。该研究的三级目的是测试 假设腹腔镜辅助结肠切除术是一种成本效益 替代开放式结肠切除术，并带来卓越的生活质量。 生活质量的可测量终点将包括症状， 功能状态和公用事业以及早期和晚期手术 并发症。成本可测量的终点将包括资源 所有机构的利用和两个机构的实际成本。到 确保有效，成功，高质量的研究，组间 机制将用于进行试验。虽然是手术 参与将仅限于展示专业知识的外科医生 腹腔镜结肠手术，各种地理位置和实践 参与机构的环境旨在最大化 多样性和结果在一般社区中的应用。