Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer - Prospective randomised trial with standard operative and histopathological techniques
Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer - Prospective randomised trial with standard operative and histopathological techniques
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DOI：
10.1080/110241599750006613
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发表时间：
1999-05-01
期刊：
影响因子：
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通讯作者：
van de Velde, CJH
中科院分区：
文献类型：
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作者：
Kapiteijn, E;Kranenbarg, EK;van de Velde, CJH
目的：探讨采用标准化的手术、放疗和病理技术治疗原发直肠癌的局部复发情况，并探讨全直肠系膜切除术后局部复发率是否允许省略术前短期放射治疗。设计：前瞻性随机研究。地点：荷兰医院80例，英国医院1例，德国医院1例，瑞典医院9例，瑞士医院1例。对象：前500例随机选择的荷兰原发直肠癌患者。主要观察指标：局部复发率、存活率、手术相关因素、肿瘤的特殊病理特征、短期和长期发病率。结果：从1996年1月到1998年4月，871名荷兰患者和94名其他患者被随机分为两组。我们的可行性分析表明，参与学科之间和学科内部的合作进展顺利。至于手术部分，这可以从顾问外科医生参加的大量手术(58%)中得到证实。腹会阴切除的数量似乎很少(30%)，涉及侧缘的百分比也很低(13%)。放疗不良反应发生率可接受。除放疗组的术中出血量较大、感染并发症发生率较高外，两组患者的发病率和死亡率均无显著差异。结论：本试验进展顺利，是可行的，即使联合TME，短期的术前放疗也是安全的。
Objective: To document local recurrence in primary rectal cancer when standardised techniques of surgery, radiotherapy, and pathology are used, and to investigate whether the local recurrence rate after total mesorectal excision permits the omission of adjuvant short term preoperative radiotherapy.Design: Prospective randomised study.Setting: Dutch (n = 80), English (n = 1), German (n = 1), Swedish (n = 9), and Swiss (n = 1) hospitals.Subjects: The first 500 randomised Dutch patients with primary rectal cancer.Main outcome measures: Local recurrence, survival, operation-related factors, specific pathological tumour characteristics, short and long term morbidity, and quality of life.Results: Between January 1996 and April 1998, 871 Dutch and 94 other patients were randomised. Our feasibility analysis shows that cooperation between and within the participating disciplines goes well. With regard to the surgical part, this can be confirmed by the large number of operations attended by consultant surgeons (58%). The number of abdominoperineal resections appeared to be low (30%), as did the percentage of lateral margins involved (13%). The rate of adverse effects of radiotherapy was acceptable. Apart from a larger operative blood loss and a higher infective complication rate in the irradiated group, no significant differences were found with regard to morbidity and mortality between the randomised groups.Conclusions: The accrual of our trial is going well and it is feasible; short term preoperative radiotherapy is safe even in combination with TME.