Randomised Oesophagectomy: Minimally Invasive or Open

Funder: NIHR/HTA

Sponsor: University Hospitals Bristol

Status: In analysis (Recruitment completed 21 Aug 2019; Follow-up completed 31 Aug 2021)

Background: Oesophageal (gullet) cancer is relatively common in the UK. If detected early, it may be cured with surgery (oesophagectomy). Different surgical approaches are routinely used to treat oesophageal (gullet) cancer – open surgery or combined open and keyhole surgery (“combined surgery”). The approaches are very similar, both approaches aim to remove the cancer and replace the gullet with the stomach. ‘Open surgery’ is performed by making large incisions in the abdomen and the chest. ‘Combined surgery’ is performed by making a large incision in the chest and 4 to 8 small cuts in the tummy. In both approaches sometimes incisions may be made to the neck.

The operation is complex and although the benefit of surgery is survival, surgery is followed by a reduction in health quality of life. At the moment we do not know which surgical approach is best for removing the cancer and for the patient in terms of recovery. The ROMIO study aims to find out which is the best surgical approach to treat oesophageal cancer.

Half of the patients who took part in ROMIO were treated with “open surgery, the other half were treated with “combined surgery”. During analysis the results of each group are being compared to see if one surgical approach is better overall than the other.

The ROMIO trial recruited 527 patients in total, at 9 surgical centres. When they are available the study results will report whether there were any important differences in surgical recovery between ‘open surgery’ and ‘combined surgery’. In the results we will also compare the cost-effectiveness of the two approaches, to provide information relevant to policy making in the NHS.