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.
- BTC (Bristol Trials Centre)