ROMIO: RCT of minimally invasive or open oesophagectomy
Research type
Research Study
Full title
The ROMIO trial. Randomised Oesophagectomy: Minimally Invasive or Open.
IRAS ID
184167
Contact name
Chris Metcalfe
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
5 years, 5 months, 30 days
Research summary
Oesophageal cancer is relatively common in the UK. If detected early, it may be cured with surgery (oesophagectomy). The operation to remove the cancer is complex with large incisions made to the abdomen, chest and, sometimes, neck. 30% of patients experience complications, and about 3% of patients die soon afterwards. Surgery improves survival rates but there is a reduction in quality of life. The limited available data suggest that minimally invasive ‘keyhole’ surgery for oesophageal cancer may achieve the same survival benefit as open surgery, but with better recovery. It is possible that the improved recovery seen in these studies may be due the selection of fitter patients for the minimally invasive procedure.
A pilot study has enabled us to refine the trial methodology for a robust RCT, designed to detect clinically important improvements in recovery with minimally invasive surgery at in 406 patients at 7 UK centres. Patients with localised oesophageal cancer, referred for surgery by their multi-disciplinary cancer care team, will be invited to join the study. Patients will be excluded if they have previous surgery or cancer that would make the oesophagectomy more difficult or are pregnant. Following informed consent, patients will be randomly allocated to open oesophagectomy (OO) or “laparoscopically-assisted” oesophagectomy (LAO). The abdominal surgery in the LAO group will use minimally invasive methods.
The primary outcome will be a validated measure of physical function. Data will also be collected on survival, days in hospital, complications, pathological specimen quality, health-related quality of life and resource use data. Follow-up is for at least two years post-randomisation.
A substudy at two centres will also randomly allocate patients to a fully minimally invasive oesophagectomy, this will provide unbiased early information on this novel approach.
REC name
South West - Frenchay Research Ethics Committee
REC reference
16/SW/0098
Date of REC Opinion
25 Apr 2016
REC opinion
Favourable Opinion