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首页> 外文期刊>Surgical Endoscopy >Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial.
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Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial.

机译：在瑞典对COLOR试验的贡献中，对患者选择和外部有效性的分析。

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OBJECTIVE: The colon cancer laparoscopic or open resection (COLOR) trial is an international, randomised controlled trial comparing outcomes of open and laparoscopic surgery for colon cancer. The main purpose of this study was to determine representability by comparing included and nonincluded patients in the participating Swedish centres. DESIGN: At eight centres, which included 391 of the 422 Swedish patients, a local database search was performed to identify retrospectively all patients (n = 2,384) who underwent surgery for colon cancer during the inclusion period, and data was retrieved from medical records. RESULTS: Four hundred fifty-six patients were randomised, 65 of whom were excluded post randomisation (group 2), leaving 391 patients in the study (group 1). For 1,566 patients, valid exclusion criteria were found (group 3). Thus, 362 patients were eligible but not included (group 4). Relative to group 1, patients in group 4 had a significantly higher American Society of Anaesthesiologists (ASA) score, more advanced tumour stage and difference regarding the resections performed. Results showed that 1470 patients (62%) could be calculated as feasible for laparoscopic colon resection (LCR) in a clinical, nontrial situation. CONCLUSIONS: The study population in the Swedish part of the COLOR trial was representative of the eligible population with the exception of comorbidity, where those actually included had less severe comorbidity than the nonincluded but eligible patients. In Sweden, 50-60% of colon cancer patients can be operated on by laparoscopy.
机译：目的：结肠癌腹腔镜或开放性切除术（COLOR）试验是一项国际性的，随机对照试验，比较了结肠癌的开放性和腹腔镜手术结局。这项研究的主要目的是通过比较参与研究的瑞典中心的纳入和未纳入患者来确定可代表性性。设计：在包括422名瑞典患者中的391名的8个中心中，进行了本地数据库搜索，以回顾性地确定所有在纳入期间接受过结肠癌手术的患者（n = 2384），并从医疗记录中检索数据。结果：456例患者被随机分组​​，其中65例在随机分组后被排除（第2组），剩下391例患者在研究中（第1组）。对于1,566例患者，发现了有效的排除标准（第3组）。因此，有362名患者符合条件，但未包括在内（第4组）。相对于第1组，第4组的患者的美国麻醉医师学会（ASA）评分明显更高，肿瘤的分期更高，并且在切除方面存在差异。结果表明，在临床非试验情况下，可以计算出1470例患者（62％）进行腹腔镜结肠切除术（LCR）是可行的。结论：在COLOR试验的瑞典部分中，研究人群代表了符合条件的人群，但合并症除外，在该人群中，实际纳入的人群合并症的严重程度低于未纳入但符合条件的患者。在瑞典，可以通过腹腔镜手术对50-60％的结肠癌患者进行手术。

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