Laparoscopically assisted vs open oesophagectomy for patients with oesophageal cancer – the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized 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 performed as an open oesophagectomy (OO), a laparoscopically-assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the NHS, 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 post-operative 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 post-operatively and 3 months post-randomisation. Secondary outcomes include: post-operative 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 IDEAL phase 2b sub-study 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 approval from South-West Frenchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.