OBJECTIVE To compare total mesorectal excision (TME) techniques combined with sphincter-sparing procedure in high-risk patients (HRPs). BACKGROUND TME is the standard treatment for rectal cancer, but can be challenging in HRPs. The available surgical approaches must be compared, especially in HRPs. METHODS Prospective, observational, multicenter trial to compare laparotomy (OTME), laparoscopy (LTME), robotic-assisted surgery (RTME), and transanal surgery (TaTME) in HRPs. The composite primary outcome included circumferential radial margin (CRM) ≥1mm, TME grade II-III, and absence of Clavien-Dindo grade III-IV complications. Three propensity score analyses were performed (LTME vs. RTME, RTME vs. TaTME, LTME vs. TaTME). RESULTS 1078 HRPs (75% of men, median body mass index of 27 kg/m2, 50% of tumors in the lower third of the rectum) underwent surgery. The RTME and TaTME groups included patients with more advanced and lower tumors and coloanal anastomosis (P<0.001). Operative time was longer for RTME surgery (P<0.001). Conversion rate was similar for minimally invasive procedures (4.5%). The global R0 resection rate was 96% without difference among techniques. The primary outcome rates were 82.4%, 64.3%, 74.7%, and 80.3% for LTME, OTME, RTME, and TaTME, respectively. None achieved the expected success rate (85%), and propensity score analyses found no differences. Operative results were similar between high- and low-volume inclusion centers only for RTME. CONCLUSIONS The RESET trial yielded high-quality results despite focusing on HRPs. Minimally invasive procedures showed similar sphincter-sparing procedure outcomes, but LTME included patients with more favorable tumors. Oncologic and functional outcomes will be evaluated at 2 years (ClinicalTrials.gov, ID: NCT03574493).

中文翻译：

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一项前瞻性欧洲试验，比较高危直肠癌患者的剖腹手术、腹腔镜手术、机器人辅助和经肛门全直肠系膜切除手术：RESET 试验。


目的 比较高危患者 (HRP) 的全直肠系膜切除 (TME) 技术与保留括约肌手术的技术。背景 TME 是直肠癌的标准治疗方法，但在 HRP 中可能具有挑战性。必须对可用的手术方法进行比较，特别是在 HRP 中。方法 前瞻性、观察性、多中心试验比较剖腹手术 (OTME)、腹腔镜手术 (LTME)、机器人辅助手术 (RTME) 和经肛门手术 (TaTME) 在 HRP 中的作用。复合主要结局包括圆周径向切缘 (CRM) ≥1mm、TME II-III 级以及不存在 Clavien-Dindo III-IV 级并发症。进行了三种倾向评分分析（LTME 与 RTME、RTME 与 TaTME、LTME 与 TaTME）。结果 1078 名 HRP（75% 的男性，中位体重指数为 27 kg/m2，50% 的肿瘤位于直肠下三分之一）接受了手术。 RTME 和 TaTME 组包括患有更晚期和较低肿瘤并进行结肠吻合术的患者 (P<0.001)。 RTME 手术的手术时间较长 (P<0.001)。微创手术的转化率相似（4.5%）。总体R0切除率为96%，技术间无差异。 LTME、OTME、RTME 和 TaTME 的主要结局发生率分别为 82.4%、64.3%、74.7% 和 80.3%。没有一个达到预期的成功率（85%），倾向评分分析没有发现差异。仅针对 RTME，高容量和低容量纳入中心的手术结果相似。结论 尽管重点关注 HRP，但 RESET 试验仍取得了高质量的结果。微创手术显示出类似的保留括约肌的手术结果，但 LTME 包括肿瘤更有利的患者。肿瘤和功能结果将在 2 年评估（ClinicalTrials.政府，ID：NCT03574493）。