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Randomized Controlled Trial
. 2019 Nov 19;9(11):e030907.
doi: 10.1136/bmjopen-2019-030907.

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)

Rachel C Brierley  1 , Daisy Gaunt  2 , Chris Metcalfe  2 , Jane M Blazeby  3   4 , Natalie S Blencowe  3   4 , Marcus Jepson  5 , Richard G Berrisford  6 , Kerry N L Avery  5 , William Hollingworth  7 , Caoimhe T Rice  7 , Aida Moure-Fernandez  7 , Newton Wong  8 , Joanna Nicklin  4 , Anni Skilton  9 , Alex Boddy  10 , James P Byrne  11 , Tim Underwood  11 , Ravi Vohra  12 , James A Catton  12 , Kish Pursnani  13 , Rachel Melhado  14 , Bilal Alkhaffaf  14 , Richard Krysztopik  15 , Peter Lamb  16 , Lucy Culliford  17 , Chris Rogers  17 , Benjamin Howes  4 , Katy Chalmers  7 , Sian Cousins  7 , Jackie Elliott  18 , Jenny Donovan  5 , Rachael Heys  17 , Robin A Wickens  17 , Paul Wilkerson  4 , Andrew Hollowood  4 , Christopher Streets  4 , Dan Titcomb  4 , Martyn Lee Humphreys  6 , Tim Wheatley  6 , Grant Sanders  6 , Arun Ariyarathenam  6 , Jamie Kelly  11 , Fergus Noble  11 , Graeme Couper  16 , Richard J E Skipworth  16 , Chris Deans  16 , Sukhbir Ubhi  10 , Robert Williams  10 , David Bowrey  10 , David Exon  10 , Paul Turner  13 , Vinutha Daya Shetty  13 , Ram Chaparala  14 , Khurshid Akhtar  14 , Naheed Farooq  14 , Simon L Parsons  12 , Neil T Welch  12 , Rebecca J Houlihan  4 , Joanne Smith  6 , Rachel Schranz  11 , Nicola Rea  16 , Jill Cooke  10 , Alexandra Williams  13 , Carolyn Hindmarsh  14 , Sally Maitland  12 , Lucy Howie  15 , Christopher Paul Barham  4
Affiliations
Randomized Controlled Trial

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)

Rachel C Brierley et al. BMJ Open. .

Abstract

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.

Keywords: minimally invasive oesophagectomy; oesophageal cancer; oesophagectomy; quality of life; randomised controlled trial.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Consort diagram outline. MDT, multidisciplinary team; PIL, patient information leaflet; TMIO, totally minimally invasive oesophagectomy; LAO, laparoscopically assisted oesophagectomy; OO, open oesophagectomy.
Figure 2
Figure 2
Diagrams representing the incisions the surgeon may make for the three different surgical approaches.
See this image and copyright information in PMC

References

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