BIG ROMIO

ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open): Definitive Trial

Summary

Oesophageal (gullet) cancer is relatively common in the UK. If found early, it may be cured with surgery ('oesophagectomy' - removal of the gullet). The aim of the operation is to remove the cancer and replace the gullet with the stomach. The benefit of surgery is survival, about 40% of patients living for at least 3 years. However, the operation is complex, 36% of patients experience complications, and about 4% of patients die soon afterwards (England & Wales audit 2017-18). After the surgery, patients often have a reduction in quality of life. There are different surgical approaches that can be used to do the oesophagectomy: open oesophagectomy (where larger cuts are made in the stomach, chest and sometimes the neck), laparoscopically-assisted oesophagectomy (where there are several small cuts in the stomach and one larger cut in the chest) and totally minimally invasive oesophagectomy (where several smaller cuts are made in both the stomach and the chest). All surgical approaches are currently used in the NHS, although totally minimally invasive oesophagectomy is a procedure that is still evolving in the UK. There is limited evidence that suggests that minimally invasive surgery may have the same survival benefit as open surgery, but with better recovery. More research is needed to find out whether this is true. ROMIO is a randomised controlled trial which is taking place in 8 UK hospitals. We have asked surgeons taking part to provide evidence of how they perform the surgery using minimally invasive techniques. Patients who have localised oesophageal cancer and are referred for surgery by their multi-disciplinary cancer care team, will be invited into the study. Patients who are pregnant or who have had previous surgery or cancer (where these will make the oesophagectomy more difficult) will not be included in the study. After being provided with information and being asked to give consent, patients will be randomly allocated (randomisation) to open oesophagectomy or laparoscopically-assisted oesophagectomy. The main question of interest is how well patients recover their physical function in the 12 weeks after surgery, which will be measured using a patient-completed questionnaire. We will recruit a total of 406 patients, which will allow us to answer this question. We will also assess whether the surgical approach affects how patients are after surgery, including quality of the tissue specimen taken during surgery, how long patients stay in hospital, any complications they experience, how long patients live and patients' quality of life. We will collect information to allow a comparison of how much each surgical approach costs the NHS. All participants will be followed up for at least two years post-surgery. Patients and members of the public have joined the study team to help us design and undertake the ROMIO study, including on issues such as how best to recruit patients to participate in the study and to design our patient information leaflets. We will publicise the study results in publicly available journals and present our findings at scientific meetings. We will also work with our public contributors on how best to make our findings accessible to patients and the public.

Links to further information

https://bristoltrialscentre.blogs.bristol.ac.uk/details-of-studies/romio/