Title: The ROMIO trial. Randomised Oesophagectomy: Minimally Invasive or Open a feasibility study
Funder: Department of Health (England)

Abstract: DESIGN: This feasibility study is built around a pilot two-centre pragmatic randomised controlled trial comparing minimally invasive and open surgical procedures in the treatment of oesophageal cancer. The feasibility work includes qualitative analysis to identify hurdles to recruitment; evaluation of methods for blinding of patients and outcome assessors; and the development of a core outcome measure set.We anticipate that the key obstacles to progression to the main trial are strong surgeon and patient preferences. These issues will impact on recruitment of patients to the study and will be addressed by the integrated qualitative research. If it proves impossible to randomise more than 50% of eligible patients even towards the end of the pilot RCT then an informative main trial may well not be feasible.SETTING: Two centres University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust. Both centres have teams of upper gastro intestinal cancer surgeons (6 in Bristol and 5 in Plymouth).TARGET POPULATION: Over a 12-month period (starting in 2012) consecutive referrals of patients with oesophageal cancer for oesophagectomy at the Bristol and Plymouth centres.HEALTH TECHNOLOGIES BEING ASSESSED: In the pilot trial we will compare 2-phase open oesophagectomy; 2-phase laparoscopically assisted oesophagectomy; and Totally minimally invasive oesophagectomy . This comparison of procedures in the pilot trial will be crucial in informing the procedures to be compared in the main trial.MEASUREMENT OF OUTCOMES: The key outcomes from the pilot trial which will inform the decision of whether to proceed with the main trial are counts of the number of potentially eligible patients per month per centre the proportion of these patients confirmed as eligible the proportion of patients agreeing to be randomly allocated to a study procedure in the pilot RCT and the proportion of randomised patients completing outcome measurements.The primary and secondary outcome measures for the main trial will be determined during the feasibility study based upon expert input from the study steering committee and the consensus meetings held to inform the core outcome set. Currently the primary outcome for the main trial is planned to be a patient report of fatigue using the MFI20. Participants will be asked to complete measurements at baseline and on the second day (assessments of pain and blinding only) 6 days 6 weeks 3 months and 6 months after surgery.MEASUREMENT OF COSTS: The best way of capturing resource use (e.g. questionnaires logs electronic versus hard copy medical records) and cost in relation to the interventions and follow-up in secondary care will be explored.SAMPLE SIZE: At the two lead centres recruitment to the pilot RCT will occur over a 12-month period with 72 potentially eligible patients being expected during that time. This will allow a true 50% recruitment rate to be estimated with a 95% confidence interval of approximately 38% to 62%. PROJECT TIMETABLE: Prior to the start of the study will seek to obtain ethical approval establish governance procedures agree contracts and recruit study staff. We propose to run the feasibility study for two years with pilot trial recruitment starting at three months continuing for twelve months and follow-up completed six months after that. We anticipate recruiting six patients per month; 72 over the 12 month recruitment period. Study milestones include the successful start and completion of the pilot trial recruitment in months 3 and 15 the successful completion of the pilot trial follow-up in month 21 and the protocol plus funding application for the main trial at the close of this feasibility study.


Research activity codes: 6.4 SURGERY
Health categories: CANCER AND NEOPLASMS