Rouanet Philippe, Guerrieri Mario, Lemercier Pablo, Balik Emre, Cotte Eddy, Spinelli Antonino, Gómez-Ruiz Marcos, Wolthuis Albert, Bertani Emilio, Dubois Anne
Department of Oncological Surgery, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.
Department of General and Emergency Surgery, Marche Polytechnic University, Ancona, AN, Italy.
Ann Surg. 2024 Sep 12. doi: 10.1097/SLA.0000000000006534.
To compare total mesorectal excision (TME) techniques combined with sphincter-sparing procedure in high-risk patients (HRPs).
TME is the standard treatment for rectal cancer, but can be challenging in HRPs. The available surgical approaches must be compared, especially in HRPs.
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).
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.
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).
比较全直肠系膜切除术（TME）技术联合保留括约肌手术在高危患者（HRP）中的应用。
TME是直肠癌的标准治疗方法，但在HRP中可能具有挑战性。必须比较现有的手术方法，尤其是在HRP中。
一项前瞻性、观察性、多中心试验，比较HRP中的开腹手术（OTME）、腹腔镜手术（LTME）、机器人辅助手术（RTME）和经肛门手术（TaTME）。复合主要结局包括环周切缘（CRM）≥1mm、TME分级II-III级以及无Clavien-Dindo III-IV级并发症。进行了三项倾向评分分析（LTME与RTME、RTME与TaTME、LTME与TaTME）。
1078例HRP接受了手术（75%为男性，中位体重指数为27kg/m²，50%的肿瘤位于直肠下三分之一）。RTME组和TaTME组包括肿瘤更晚期、位置更低且行结肠肛管吻合术的患者（P<0.001）。RTME手术的手术时间更长（P<0.001）。微创手术的中转率相似（4.5%）。总体R0切除率为96%，各技术之间无差异。LTME、OTME、RTME和TaTME的主要结局率分别为82.4%、64.3%、74.7%和80.3%。均未达到预期成功率（85%），倾向评分分析未发现差异。仅RTME在高容量和低容量纳入中心的手术结果相似。
尽管RESET试验聚焦于HRP，但仍产生了高质量的结果。微创手术显示出相似的保留括约肌手术结局，但LTME组患者的肿瘤情况更有利。将在2年时评估肿瘤学和功能结局（ClinicalTrials.gov，标识符：NCT03574493）。
