Moloo H, Sabri E, Wassif E, Haggar F, Poulin E C, Mamazza J, Boushey R P
Department of Surgery, Ottawa Hospital, Ottawa, Ontario, Canada.
Dis Colon Rectum. 2008 Feb;51(2):173-80. doi: 10.1007/s10350-007-9132-0. Epub 2007 Dec 22.
This study was designed to assess whether the exclusion criteria used in the Clinical Outcomes of Surgical Therapy and Colon Cancer Laparoscopic or Open Resection trials affected the generalizability of their findings.
A prospective database of consecutive laparoscopic resections performed for colon cancer was reviewed. Patients were categorized into two groups: inclusion group and exclusion group, based on the selection criteria used in the Clinical Outcomes of Surgical Therapy and Colon Cancer Laparoscopic or Open Resection trials. Baseline and perioperative data were analyzed by using t-tests, Wilcoxon's rank-sum, chi-squared, and Fisher's exact test. Kaplan-Meier survival curves, followed by adjustment for tumor nodes metastasis stage and age utilizing a Cox proportional hazard model, were performed.
The inclusion group had 221 patients and the exclusion group had 166 (median age and gender distribution were similar). The exclusion group had a higher conversion rate (23 vs. 11.3 percent; P=0.0023). There was no difference in intraoperative complications (9 percent for exclusion group vs. 8.6 percent for inclusion group; P=0.8), operative time (180 minutes for exclusion group vs.172 minutes for inclusion group; P=0.24), or postoperative complication rates (33.7 percent for exclusion group vs. 26 percent for inclusion group; P=0.13). No difference was detected in perioperative mortality rates, length of stay, days to diet as tolerated, and adjusted two-year survival.
No differences were found in outcomes between the two groups in terms of operative/postoperative complications, length of stay, perioperative mortality, and two-year survival. It seems that all patients with colon cancer can potentially benefit from a laparoscopic approach.
本研究旨在评估外科治疗临床结果以及结肠癌腹腔镜或开放切除术试验中所使用的排除标准是否影响了其研究结果的普遍性。
回顾了一个针对结肠癌进行的连续腹腔镜切除术的前瞻性数据库。根据外科治疗临床结果以及结肠癌腹腔镜或开放切除术试验中所使用的选择标准，将患者分为两组：纳入组和排除组。通过t检验、Wilcoxon秩和检验、卡方检验和Fisher精确检验对基线和围手术期数据进行分析。绘制Kaplan-Meier生存曲线，随后利用Cox比例风险模型对肿瘤淋巴结转移分期和年龄进行校正。
纳入组有221例患者，排除组有166例（中位年龄和性别分布相似）。排除组的中转率更高（23%对11.3%；P = 0.0023）。术中并发症（排除组为9%，纳入组为8.6%；P = 0.8）、手术时间（排除组为180分钟，纳入组为172分钟；P = 0.24）或术后并发症发生率（排除组为33.7%，纳入组为26%；P = 0.13）无差异。围手术期死亡率、住院时间、可耐受饮食天数和校正后的两年生存率未检测到差异。
两组在手术/术后并发症、住院时间、围手术期死亡率和两年生存率方面的结果未发现差异。似乎所有结肠癌患者都可能从腹腔镜手术方法中获益。
