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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

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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

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 post-operatively 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 robotic-assisted and standard laparoscopic surgery for the curative resection of rectal cancer.

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Acknowledgements

This research grant has been awarded by the Efficacy and Mechanism Evaluation (EME) programme, which is funded by the Medical Research Council and managed by the National Institute for Health Research. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the MRC, NHS, NIHR or the Department of Health.

Competing interests

The authors declare that they have no competing interests.

Author information

Authors and Affiliations

  1. Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK

    Fiona J. Collinson, Ivana Holloway, Helen Howard, Helen Marshall, Carly S. Rivers & Julia M. B. Brown

  2. Section of Translational Anaesthesia and Surgery, St. James’s University Hospital, Level 7, Clinical Sciences Building, Leeds, LS9 7TF, UK

    David G. Jayne

  3. City of Hope National Medical Center, Duarte, CA, USA

    Alessio Pigazzi

  4. Division of Colorectal Surgery, University Surgical Cluster, National University Cancer Institute, Singapore, Singapore

    Charles Tsang

  5. Department of Mechanical Engineering, University of Leeds, Leeds, UK

    Jennifer M. Barrie

  6. Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah Building, 101 Clarendon Road, Leeds, LS2 9LJ, UK

    Richard Edlin & Christopher McCabe

  7. Faculty of Arts, Environment and Technology, Leeds Metropolitan University, Northern Terrace, Queen’s Square Court, Leeds, LS2 8AJ, UK

    Christopher Garbett

  8. Leeds Institute of Molecular Medicine, St James’s University Hospital, Level 7, Clinical Sciences Building, Leeds, LS9 7TF, UK

    Pierre Guillou

  9. Leeds Institute of Health Sciences, University of Leeds, Room 2.32 Charles Thackrah Building, 101 Clarendon Road, Leeds, LS2 9LJ, UK

    Sue Pavitt

  10. Yorkshire Cancer Research Centenary Chair of Pathology and Honorary Consultant, St. James’s Hospital, Leeds Institute of Molecular Medicine, Leeds, LS9 7TF, UK

    Phil Quirke

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  1. Fiona J. Collinson
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Corresponding author

Correspondence to David G. Jayne.

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Collinson, F.J., Jayne, D.G., Pigazzi, A. et al. An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. Int J Colorectal Dis 27, 233–241 (2012). https://doi.org/10.1007/s00384-011-1313-6

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