Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer—the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT)

Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer—the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT)

Introduction Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be perfo...

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Main Authors: Chris Rogers, Jane M Blazeby, Fergus Noble, Grant Sanders, Simon L Parsons, Rachael Heys, Lucy Culliford, Natalie S Blencowe, Daisy Gaunt, Andrew Hollowood, Alex Boddy, Newton Wong, Benjamin Howes, William Hollingworth, Jackie Elliott, Marcus Jepson, Peter Lamb, Rachel Melhado, Richard Krysztopik, Bilal Alkhaffaf, Tim Underwood, Paul Wilkerson, Christopher Streets, Dan Titcomb, Tim Wheatley, Arun Ariyarathenam, Jamie Kelly, Graeme Couper, Chris Deans, David Bowrey, David Exon, Paul Turner, Ram Chaparala, Khurshid Akhtar, Naheed Farooq, Nicola Rea, Sian Cousins, Alexandra Williams, Richard J E Skipworth, Joanna Nicklin, James P Byrne, Rachel C Brierley, Richard G Berrisford, Kerry N L Avery, Caoimhe T Rice, Aida Moure-Fernandez, Ravi Vohra, James A Catton, Kish Pursnani, Katy Chalmers, Robin A Wickens, Martyn Lee Humphreys, Sukhbir Ubhi, Robert Williams, Vinutha Daya Shetty, Neil T Welch, Rebecca J Houlihan, Joanne Smith, Rachel Schranz, Jill Cooke, Carolyn Hindmarsh, Sally Maitland, Christopher Paul Barham
Format: Article
Language:English
Published: BMJ Publishing Group 2019-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/11/e030907.full
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Summary:Introduction Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life.Methods and analysis We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.Ethics and dissemination This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.Trial registration number ISRCTN10386621.
ISSN:2044-6055

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