Deijen Charlotte L, Velthuis Simone, Tsai Alice, Mavroveli Stella, de Lange-de Klerk Elly S M, Sietses Colin, Tuynman Jurriaan B, Lacy Antonio M, Hanna George B, Bonjer H Jaap
Department of Surgery, VU University Medical Centre, Postbus 7057, 1007 MB, Amsterdam, The Netherlands.
Department of Surgery, Gelderse Vallei Hospital Ede, Ede, The Netherlands.
Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.
Total mesorectal excision (TME) is an essential component of surgical management of rectal cancer. Both open and laparoscopic TME have been proven to be oncologically safe. However, it remains a challenge to achieve complete TME with clear circumferential resections margin (CRM) with the conventional transabdominal approach, particularly in mid and low rectal tumours. Transanal TME (TaTME) was developed to improve oncological and functional outcomes of patients with mid and low rectal cancer.
An international, multicentre, superiority, randomised trial was designed to compare TaTME and conventional laparoscopic TME as the surgical treatment of mid and low rectal carcinomas. The primary endpoint is involved CRM. Secondary endpoints include completeness of mesorectum, residual mesorectum, morbidity and mortality, local recurrence, disease-free and overall survival, percentage of sphincter-saving procedures, functional outcome and quality of life. A Quality Assurance Protocol including centralised MRI review, histopathology re-evaluation, standardisation of surgical techniques, and monitoring and assessment of surgical quality will be conducted.
The difference in involvement of CRM between the two treatment strategies is thought to be in favour of the TaTME. TaTME is therefore expected to be superior to laparoscopic TME in terms of oncological outcomes in case of mid and low rectal carcinomas.
全直肠系膜切除术（TME）是直肠癌外科治疗的重要组成部分。开放和腹腔镜TME均已被证明在肿瘤学上是安全的。然而，采用传统经腹入路实现完整的TME并获得清晰的环周切缘（CRM）仍然是一项挑战，尤其是在中低位直肠癌中。经肛门全直肠系膜切除术（TaTME）的发展旨在改善中低位直肠癌患者的肿瘤学和功能结局。
设计了一项国际多中心优效性随机试验，比较TaTME与传统腹腔镜TME作为中低位直肠癌的手术治疗方法。主要终点是CRM受累情况。次要终点包括直肠系膜完整性、残留直肠系膜、发病率和死亡率、局部复发、无病生存期和总生存期、保肛手术百分比、功能结局和生活质量。将实施一项质量保证方案，包括集中MRI评估、组织病理学重新评估、手术技术标准化以及手术质量的监测和评估。
两种治疗策略在CRM受累情况方面的差异被认为有利于TaTME。因此，在中低位直肠癌的情况下，TaTME在肿瘤学结局方面有望优于腹腔镜TME。
