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目的比较肛提肌外腹会阴联合切除术(extralevatory abdominoperineal excision,ELAPE)和传统腹会阴联合切除术(abdominoperineal excision,APE)在肿瘤结局和潜在获益方面的差异。背景ELAPE手术最早在2007年被提出,其目的是降低低位直肠癌术后的阳性切缘率。初步研究显示ELAPE手术具有良好的结果,然而尚无大规模或全国性的数据支持。方法此项研究源自丹麦结直肠肿瘤学组的前瞻性数据库。研究者提取了2009年1月1日至2012年8月间在丹麦完成的ELAPE和APE手术数据,比较二者在人口统计学、肿瘤特征和肿瘤结局方面的差异,并利用单因素和多因素逻辑回归分析确定阳性环周切缘的危险因素。结果研究共纳入554例患者,其中ELAPE组301例(54%),APE组253例(46%),63%为男性,中位年龄69岁(四分位数间距61~76岁),大部分肿瘤的T分期为T2和T3(分别占32%和45%)。结果显示,两组的人口学特征、T分期和N分期无统计学差异。共13%的患者环周切缘阳性,ELAPE组环周切缘阳性率更高(16%vs.7%,P=0.006)。单因素和多因素逻辑回归分析提示ELAPE手术是环周切缘阳性的危险因素(OR=2.59,95%CI:1.31~5.12,P=0.006)。结论该项全国性研究表明,与传统APE手术比较,ELAPE手术不能改善低位直肠癌患者的短期肿瘤结局。
Objective To compare the difference in tumor outcome and potential benefit between extra-levator abdominoperineal excision (ELAPE) and conventional abdominoperineal excision (APE). Background ELAPE surgery was first proposed in 2007 to reduce the positive postoperative margins of low rectal cancer. Preliminary studies have shown good results with ELAPE surgery, however, there is no data support that is large-scale or national. Methods This study was based on a prospective database from the Danish Colorectal Oncology Group. The researchers extracted data on ELAPE and APE performed in Denmark from January 1, 2009 to August 2012 and compared demographics, tumor characteristics, and tumor outcome using single and multiple-factor Logistic regression analysis identified risk factors for positive circumferential margins. Results A total of 554 patients were enrolled in the study, 301 (54%) in the ELAPE group and 253 (46%) in the APE group, 63% were male, with a median age of 69 years (interquartile range 61-76 years) T-staging of some tumors was T2 and T3 (32% and 45%, respectively). The results showed that the two groups of demographic characteristics, T stage and N stage no significant difference. A total of 13% of patients had positive circumferential margins, and the positive margins of ELAPE peripheral margins were higher (16% vs 7%, P = 0.006). Univariate and multivariate logistic regression analysis showed that ELAPE was a positive risk factor for circumferential margin (OR = 2.59, 95% CI: 1.31-5.12, P = 0.006). Conclusions This nationwide study shows that ELAPE does not improve short-term tumor outcome in patients with low rectal cancer compared to conventional APE surgery.