Division of Colorectal Surgery, State University of New York, Stony Brook, New York, USA.
Department of Colorectal Surgery, National Cancer Institute, Naples, Italy.
Colorectal Dis. 2017 Feb;19(2):148-157. doi: 10.1111/codi.13436.
A randomized controlled trial was conducted to test the null hypothesis that there is no difference in circumferential resection margin (CRM) between extralevator abdominoperineal excision (ELAPE) and non-ELAPE for rectal cancer.
This was a multicentre, randomized controlled trial registered as NCT01702116. Patients with rectal cancer involving the external anal sphincter were randomized to ELAPE or non-ELAPE following neoadjuvant chemoradiation. Randomization was performed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. The primary end-point was CRM (in mm), defined as the shortest distance between the tumour and the cut edge of the specimen. Pathologists and centralized pathology were blinded to the patients' study arm. Interrater reliability (IRR) was assessed using Kendall's coefficient. Intra-operative perforation (IOP) was any rectal defect determined at pathology. Complications were classified using the Clavien-Dindo classification. Participating surgeons were retrained and credentialed. A sample size calculation showed that 34 subjects would provide sufficient power to reject the null hypothesis.
Thirty-four patients underwent the allocated intervention. Seventeen patients treated with ELAPE were comparable with 17 patients treated with non-ELAPE regarding age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) class and pre-existing comorbidities. CRM depth (7.14 ± 5.76 mm vs 2.98 ± 3.28 mm, P = 0.016) and involvement rates (5.8% vs 41.0%, P = 0.04) were significantly increased in patients treated with ELAPE. The IRR for CRM was 0.78. There were no significant differences in IOP (5.8% vs 11.7%, P = 0.77) and complication rates (29% vs 29%, P = 0.97).
ELAPE was associated with statistically improved CRM with no difference in IOP and complication rates compared with non-ELAPE for rectal cancer involving the external anal sphincter.
本研究旨在通过一项随机对照试验来检验以下无效假设，即接受经肛提肌外腹会阴联合切除术（ELAPE）和非 ELAPE 治疗的直肠癌患者的环周切缘（CRM）之间没有差异。
这是一项多中心、随机对照试验，登记号为 NCT01702116。接受新辅助放化疗的、伴有外括约肌受累的直肠癌患者被随机分配至 ELAPE 或非 ELAPE 组。随机分组根据 CONSORT 指南进行。主要终点是 CRM（mm），定义为肿瘤与标本切缘之间的最短距离。病理学家和中心病理科对患者的研究分组情况设盲。采用 Kendall 系数评估组间一致性（IRR）。术中穿孔（IOP）是指在病理学上确定的任何直肠缺陷。并发症的分类采用 Clavien-Dindo 分级。参与手术的医生接受了再培训和认证。样本量计算显示，34 例患者即可提供足够的效能来拒绝无效假设。
34 例患者接受了分配的干预措施。17 例接受 ELAPE 治疗的患者与 17 例接受非 ELAPE 治疗的患者在年龄、性别、体重指数（BMI）、美国麻醉医师协会（ASA）分级和既往合并症方面具有可比性。ELAPE 组的 CRM 深度（7.14±5.76mm 比 2.98±3.28mm，P=0.016）和累及率（5.8%比 41.0%，P=0.04）显著升高。CRM 的 IRR 为 0.78。接受 ELAPE 治疗和非 ELAPE 治疗的患者在 IOP（5.8%比 11.7%，P=0.77）和并发症发生率（29%比 29%，P=0.97）方面无显著差异。
与非 ELAPE 相比，ELAPE 治疗伴有外括约肌受累的直肠癌患者的 CRM 显著改善，而 IOP 和并发症发生率无差异。
