ROMIO

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Randomised Oesophagectomy: Minimally Invasive or Open

Funder: NIHR/HTA

Sponsor: University Hospitals Bristol

Status: In Follow Up 

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 take part will be treated with “open surgery”, the other half will be treated with “combined surgery”. The results of each group will be compared to see if one surgical approach is better overall than the other.

The ROMIO trial will recruit 406 patients in total, at 8 surgical centres which will allow important differences in surgical recovery to be detected. We will also collect data, to allow a comparison of the cost-effectiveness of the two approaches to provide information relevant to policy making in the NHS.

Publications

Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial

Protocol paper

Quality Assurance Protocol paper 

The latest site newsletter and patient newsletter

NIHR Award Information

Contact Information

Chief Investigator: Chris Metcalfe

Study coordinator: Liz Ward

E-mailromio-study@bristol.ac.uk