Department of Surgery, University Medical Centre, Groningen, The Netherlands.
Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands.
BMJ Open. 2022 Aug 19;12(8):e057640. doi: 10.1136/bmjopen-2021-057640.
Total mesorectal excision is the standard of care for rectal cancer, which can be performed using open, laparoscopic, robot-assisted and transanal technique. Large prospective (randomised controlled) trials comparing these techniques are lacking, do not take into account the learning curve and have short-term or long-term oncological results as their primary endpoint, without addressing quality of life, functional outcomes and cost-effectiveness. Comparative data with regard to these outcomes are necessary to identify the optimal minimally invasive technique and provide guidelines for clinical application.
This trial will be a prospective observational multicentre cohort trial, aiming to compare laparoscopic, robot-assisted and transanal total mesorectal excision in adult patients with rectal cancer performed by experienced surgeons in dedicated centres. Data collection will be performed in collaboration with the prospective Dutch ColoRectal Audit and the Prospective Dutch ColoRectal Cancer Cohort. Quality of life at 1 year postoperatively will be the primary outcome. Functional outcomes, cost-effectiveness, short-term outcomes and long-term oncological outcomes will be the secondary outcomes. In total, 1200 patients will be enrolled over a period of 2 years in 26 dedicated centres in the Netherlands. The study is registered at https://www.trialregister.nl/9734 (NL9734).
Data will be collected through collaborating parties, who already obtained approval by their medical ethical committee. Participants will be included in the trial after having signed informed consent. Results of this study will be disseminated to participating centres, patient organisations, (inter)national society meetings and peer-reviewed journals.
全直肠系膜切除术是直肠癌的标准治疗方法，可通过开腹、腹腔镜、机器人辅助和经肛门技术进行。缺乏比较这些技术的大型前瞻性（随机对照）试验，这些试验没有考虑到学习曲线，并且将短期或长期的肿瘤学结果作为主要终点，而没有解决生活质量、功能结果和成本效益。需要比较这些结果的数据，以确定最佳的微创技术，并为临床应用提供指南。
本试验将是一项前瞻性观察性多中心队列研究，旨在比较经验丰富的外科医生在专门中心对直肠腺癌患者进行的腹腔镜、机器人辅助和经肛门全直肠系膜切除术。数据收集将与前瞻性荷兰结肠直肠审计和前瞻性荷兰结肠直肠癌队列合作进行。术后 1 年的生活质量将是主要结果。功能结果、成本效益、短期结果和长期肿瘤学结果将是次要结果。在荷兰的 26 个专门中心，将在 2 年内招募 1200 名患者。该研究在 https://www.trialregister.nl/9734（NL9734）注册。
数据将通过合作方收集，这些合作方已经获得了他们的医学伦理委员会的批准。在参与者签署知情同意书后，将其纳入试验。本研究的结果将传播给参与中心、患者组织、（国际）学会会议和同行评议期刊。
