COLOR - A randomized clinical trial comparing laparoscopic and open resection for colon cancer
COLOR - A randomized clinical trial comparing laparoscopic and open resection for colon cancer
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DOI：
10.1007/s00464-001-8165-z
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发表时间：
2002-06-01
影响因子：
3.1
通讯作者：
Hazebroek, EJ
中科院分区：
文献类型：
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作者：
Hazebroek, EJ
背景：腹腔镜手术已被证明是安全有效的。然而，腹腔镜切除术对于癌症结果的价值只能通过大型前瞻性随机临床试验和足够的随访来评估。方法：COLOR（结肠癌腹腔镜或开放切除术）是一项于 1997 年开始的欧洲多中心随机试验。在瑞典、荷兰、德国、法国、意大利、西班牙和英国的 27 家医院中， 将包括1200名患者。该研究的主要终点是 3 年后的无癌生存期。结果：在 < 3.5 年内，> 850 名患者被随机分配接受右半结肠切除术 (47%)。左半结肠切除术（11%）和乙状结肠切除术（42%）。随机分组后，57 名患者被排除。试验开始后 46 个月，总体复发率为 6.8%。疾病分期分布如下：I期，25%； II期，41%； III期，32%； IV 期，2%。结论：虽然腹腔镜手术似乎对结直肠癌的治疗有价值，但需要考虑随机试验的最终结果来确定其最终作用。鉴于目前的累积率，COLOR 研究将于 2002 年完成。
Background: Laparoscopic surgery has proven to be safe and effective. However, the value of laparoscopic resection for malignancy in terms of cancer outcome can only be assessed by large prospective randomized clinical trials with sufficient follow-up.Methods: COLOR (COlon carcinoma Laparoscopic or Open Resection) is a European multicenter randomized trial that began in 1997. In 27 hospitals in Sweden, The Netherlands, Germany, France, Italy, Spain, and the United Kingdom, 1200 patients will be included. The primary endpoint of the study is cancer-free survival after 3 years.Results: In < 3.5 years, > 850 patients have been randomized for right hemicolectomy (47%). left hemicolectomy (11%), and sigmoidectomy (42%). Fifty seven patients were excluded after randomization. Forty six months after the start of the trial, the overall recurrence rate is 6.8%. The distribution of stage of disease is as follows: stage I, 25%; stage II, 41%; stage III, 32%; stage IV, 2%.Conclusion: Although laparoscopic surgery appears to be of value in the treatment of colorectal cancer, the final, results of randomized trials need to be considered to determine its definitive role. Given the current accrual rate, the COLOR study will be completed in 2002.