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首页> 外文期刊>International journal of colorectal disease. >An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer
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An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer

机译：机器人辅助与标准腹腔镜手术的国际，多期中心，前瞻性，随机，控制，未粘性，并行群试验，用于治疗直肠癌的治疗方法

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Purpose There is growing enthusiasm for robotic-assisted laparoscopic operations across many surgical specialities, including colorectal surgery, often not supported by robust clinical or cost-effectiveness data. A proper assessment of this new technology is required, prior to widespread recommendation or implementation. Methods/design The ROLARR trial is a pan-world, prospective, randomised, controlled, unblinded, superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. It will investigate differences in terms of the rate of conversion to open operation, rate of pathological involvement of circumferential resection margin, 3-year local recurrence, disease-free and overall survival rates and also operative morbidity and mortality, quality of life and cost-effectiveness. The primary outcome measure is the rate of conversion to open operation. For 80% power at the 5% (two-sided) significance level, to identify a relative 50% reduction in open conversion rate (25% to 12.5%), 336 patients will be required. The target recruitment is 400 patients overall to allow loss to follow-up. Patients will be followed up at 30 days and 6 months postoperatively and then annually until 3 years after the last patient has been randomised. Discussion In many centres, robotic-assisted surgery is being implemented on the basis of theoretical advantages, which have yet to be confirmed in practice. Robotic surgery is an expensive health care provision and merits robust evaluation. The ROLARR trial is a pragmatic trial aiming to provide a comprehensive evaluation of both roboticassisted and standard laparoscopic surgery for the curative resection of rectal cancer.
机译：目的在许多外科专业的机器人辅助腹腔镜操作中，在包括结肠直肠手术，通常不受稳健的临床或成本效益数据的支持。在广泛推荐或实施之前，需要对这种新技术进行适当的评估。方法/设计Rolarr试验是一种泛世界，前瞻性，随机，受控，未结合的机器人辅助和标准腹腔镜手术的优势试验，用于直肠癌治疗。它将研究转换率的差异，以开放运作，圆周切除率的病理划分率，3年局部复发，疾病和整体生存率以及手术发病率和死亡率，生活质量和成本 - 效力。主要结果措施是转换速度开放运作。对于5％（双面）显着性水平的80％功率，以确定开放转化率降低的相对50％（25％至12.5％），将需要336名患者。目标招聘是400名患者，以便损失随访。患者将在术后30天和6个月内随访，然后每年直到最后3年后，在最后一次患者随机化之后。在许多中心讨论，机​​器人辅助手术是在理论优势的基础上实施，尚未在实践中确认。机器人手术是一种昂贵的医疗保健，优点是稳健的评估。 Rolarr试验是一个务实的试验，旨在为抢劫和标准腹腔镜手术进行全面评估，用于直肠癌的治疗切除术。

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    CollinsonF.J.; JayneD.G.; PigazziA.; TsangC.; BarrieJ.M.; EdlinR.; GarbettC.; GuillouP.; HollowayI.; HowardH.; MarshallH.; McCabeC.; PavittS.; QuirkeP.; RiversC.S.; BrownJ.M.B.;

  • 作者单位

    Clinical Trials Research Unit University of Leeds Leeds LS2 9JT United Kingdom;

    Section of Translational Anaesthesia and Surgery St. James's University Hospital Clinical;

    City of Hope National Medical Center Duarte CA United States;

    Division of Colorectal Surgery University Surgical Cluster National University Cancer Institute;

    Department of Mechanical Engineering University of Leeds Leeds United Kingdom;

    Leeds Institute of Health Sciences University of Leeds Academic Unit of Health Economics 101;

    Faculty of Arts Environment and Technology Leeds Metropolitan University Northern Terrace Queen;

    Leeds Institute of Molecular Medicine St James's University Hospital Clinical Sciences Building;

    Clinical Trials Research Unit University of Leeds Leeds LS2 9JT United Kingdom;

    Clinical Trials Research Unit University of Leeds Leeds LS2 9JT United Kingdom;

    Clinical Trials Research Unit University of Leeds Leeds LS2 9JT United Kingdom;

    Leeds Institute of Health Sciences University of Leeds Academic Unit of Health Economics 101;

    Leeds Institute of Health Sciences University of Leeds Charles Thackrah Building 101 Clarendon;

    Yorkshire Cancer Research Centenary Department of Pathology and Honorary Consultant St. James's;

    Clinical Trials Research Unit University of Leeds Leeds LS2 9JT United Kingdom;

    Clinical Trials Research Unit University of Leeds Leeds LS2 9JT United Kingdom;

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  • 正文语种 eng
  • 中图分类 消化系及腹部疾病;
  • 关键词

    Circumferential resection margin; Laparoscopic surgery; Rectal cancer; Robotic-assisted surgery;

    机译：周向切除余量;腹腔镜手术;直肠癌;机器人辅助手术;

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