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: 2107976
• 负责人: HEIDI NELSON
• 金额: $ 73.43万
• 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/2107976
• 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.

尽管许多重要的医学进步，手术仍然是主要的 109,000 名患者中的大多数人的治疗方式 每年新诊断出患有结肠癌。手术不仅提供 摘除原发肿瘤，可缓解症状并预防 并发症，但此外还提供重要的分期信息。 尽管开腹结肠切除术的肿瘤学结果已得到充分证实，但这些 传统的切除和分期技术受到挑战 引进微创手术。腹腔镜胆囊切除术， 微创切除手术的例子已迅速成为 胆石症首选手术方法，因为 减少恢复时间、残疾和费用。已提出 结肠微创手术可能具有类似的优势。 可以使用以下方法进行结肠微创切除术 腹腔镜技术结扎脉管系统、动员和外显 肠，以及体外技术来切除和吻合肠。 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、可行的， 并减少恢复时间、残疾和成本。迄今为止严格 尚未进行生活质量和成本分析，并进一步 人们对这项技术的充分性表示担忧 结肠癌的分期和治疗，结肠切除术的常见适应症。 一项前瞻性随机试验在三年内招募了 1,200 名患者 提议解决三个具体目标，该研究的主要目标是 检验无病生存率和总生存率的假设 无论患者是否接受腹腔镜辅助或 开放性结肠切除术。如果对癌症结果有重大不利影响 检测到，则不建议进一步分析。然而，如果 腹腔镜辅助结肠切除术不会对无病或无病患者产生不利影响 总体生存率然后将测试进一步的目标。的次要目标 该研究旨在确定腹腔镜辅助结肠切除术的安全性 与开腹结肠切除术相比，特别是在手术方面 发病率和死亡率。该研究的第三个目标是测试 假设腹腔镜辅助结肠切除术具有成本效益 替代开放式结肠切除术，并带来更高的生活质量。 生活质量的可衡量终点包括症状、 功能状态和效用，以及早期和晚期手术 并发症。可衡量的成本终点将包括资源 所有机构的利用率和两个机构的实际成本。到 确保高效、成功、高质量的研究 将使用机制进行审判。虽然手术 参与仅限于具有以下专业知识的外科医生 腹腔镜结肠手术的不同地理位置和实践 参与机构的环境旨在最大限度地 多样性以及将结果应用于一般社区。