Meillat Helene, Saadoun Jacques Emmanuel, Zemmour Christophe, Illy Mathias, Poizat Flora, Ratone Jean-Philippe, Dazza Marie, de Chaisemartin Cécile, Lelong Bernard
Department of Digestive Surgical Oncology, Institut Paoli-Calmettes, 232 Boulevard Sainte Marguerite, 13009, Marseille, France.
Department of Clinical Research and Innovation, Biostatistics and Methodology Unit, Institut Paoli-Calmettes, IRD, SESSTIM, Aix Marseille University, Marseille, France.
Tech Coloproctol. 2024 Dec 19;29(1):27. doi: 10.1007/s10151-024-03065-4.
Transanal total mesorectal excision (TaTME) is a promising and innovative approach for lower rectal cancer but requires high technical skill and learning process that can affect patient outcomes. We aimed to determine the learning curve of TaTME and then to assess its impact on 5-year oncologic outcomes.
Over a 54-month period, 94 patients underwent TaTME by experienced laparoscopic colorectal surgeons at our department. To provide a comprehensive overview of success, we used a composite criterion including the most relevant parameters related to the learning process: the conversion rate to an open procedure, TaTME procedure completion, severe postoperative morbidity, mesorectal integrity on macroscopic evaluation, and microscopic margins. Moving average method and cumulative sum analyses were performed.
The operative time continuously decreased over the entire study period. The success rate stabilised after 14 patients in a parallel and balanced analysis of the two surgeons' experiences. Mesorectal completeness was the most sensitive marker for the TaTME learning process (42.9% vs 71.25%; p = 0.06). The learning process did not significantly affect the postoperative morbidity, conversion rate, or R0 resection. Five-year oncological outcomes were similar between the groups.
Even among laparoscopically experienced surgeons, the TaTME learning process influences the oncological quality of the resection but not the postoperative morbidity. Gaining an early command of the surgical anatomy and technical skills and understanding the challenges through specific educational sessions are necessary. The results of this study could help generate a comprehensive training program and define necessary prerequisites for prospective trials.
This study is registered in our Clinical Research Unit (2016_LELONG_01). Our database is registered in the clinicalTrials.gov registry: Institut Paoli Calmettes Colorectal Cancer Database (NCT02869503).
经肛门全直肠系膜切除术（TaTME）是一种治疗低位直肠癌的有前景且创新的方法，但需要较高的技术水平和学习过程，这可能会影响患者的预后。我们旨在确定TaTME的学习曲线，然后评估其对5年肿瘤学预后的影响。
在54个月的时间里，我们科室经验丰富的腹腔镜结直肠外科医生为94例患者实施了TaTME手术。为全面了解手术的成功情况，我们采用了一个综合标准，包括与学习过程最相关的参数：转为开放手术的比例、TaTME手术完成情况、严重术后并发症、大体评估的直肠系膜完整性以及显微镜下切缘情况。采用移动平均法和累积和分析。
在整个研究期间，手术时间持续下降。在对两位外科医生的经验进行平行和平衡分析时，14例患者之后成功率趋于稳定。直肠系膜完整性是TaTME学习过程中最敏感的指标（42.9%对71.25%；p = 0.06）。学习过程对术后并发症、转为开放手术的比例或R0切除率没有显著影响。两组之间的5年肿瘤学预后相似。
即使在有腹腔镜经验的外科医生中，TaTME的学习过程也会影响切除的肿瘤学质量，但不影响术后并发症。尽早掌握手术解剖结构和技术技能，并通过特定的教育课程了解其中的挑战是必要的。本研究结果有助于制定全面的培训计划，并为前瞻性试验确定必要的前提条件。
本研究已在我们的临床研究单位注册（2016_LELONG_01）。我们的数据库已在clinicalTrials.gov注册：Institut Paoli Calmettes结直肠癌数据库（NCT02869503）。
