Surgeons are testing whether removing oesophageal cancer through keyhole incisions leads to a better recovery than traditional open surgery. Oesophagectomy—removing part or all of the gullet—is a major operation with high complication rates. Surgeons disagree about whether minimally invasive techniques, which avoid cutting through the chest wall, actually improve patient outcomes. The ROMIO trial directly compares open oesophagectomy with laparoscopically-assisted oesophagectomy in a randomised controlled trial across eight UK surgical centres. If the trial shows that the keyhole approach improves physical recovery without compromising cancer survival, it could change the standard of care for oesophageal cancer surgery in the NHS. A shift to minimally invasive techniques would mean shorter hospital stays, less post-surgical pain, and better lung function for patients. The trial also includes a health economics analysis to determine whether the new approach is cost-effective from the NHS perspective, which will help guide funding decisions. A sub-study at two centres is additionally exploring a totally minimally invasive approach, providing early data on an even less invasive option.
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DESIGN: Parallel group multi-centre RCT SETTING: Eight UK Upper GI surgical centres: Bristol/Bath, Plymouth, Southampton, Leicester, Preston, Edinburgh, Salford/Manchester & Nottingham. Criteria will be set for surgeons who want to join the trial and quality of surgery will be assessed prior to & during the trial1. POPULATION: Patients with localised oesophageal cancer selected for primary oesophagectomy or surgery following neoadjuvant treatment by a UGI MDT. INCLUSION: Age =18 years with oesophageal cancer, referred for surgery by UGI MDT, where tumour is >5cm below crico-pharyngeus and involves <4cm of gastric wall. Final pre-treatment tumour stage is between T1N0M0 and T4aN1M0. EXCLUSION: Evidence of previous complex thoracotomies or laparotomies; previous/concomitant malignancy which would interfere with the surgery; pregnancy; high grade dysplasia. INTERVENTIONS: Open oesophagectomy (OO), laparoscopically-assisted oesophagectomy (LAO). HEALTH ECONOMICS: We will collect data to measure the costs of treatments in-theatre and in-hospital, community care and personal social services. We will also measure quality of life using the EQ5D instrument. We will use this, along with vital statistics to calculate quality adjusted life years (QALYs). We will look at the economic costs and benefits from NHS & personal social services perspectives. We will analyse the data collected to determine the cost-effectiveness of the different surgical approaches in the NHS. ROUTINE DATA: We will review medical records for health data and the NHS Central Register for vital status. With patient consent, we also plan to link with external datasets (including Intensive Care National Audit Research Centre (ICNARC); Information Services Division (ISD) Scotland; National Cancer Registry Analysis Services (NCRAS); Systemic Anti-Cancer Therapy (SACT) dataset; Radiotherapy Dataset (RTDS); Hospital Episode Statistics (HES) datasets). OUTCOME MEASURES: The primary outcome will be the mean EORTC QLQ-C30 physical function scale (a validated measure of recovery), assessed 3 and 6 weeks post-surgery and 12 weeks post-randomisation. Secondary outcomes include all-cause complications, lung function, post-surgical pain, quality assurance of surgery, other aspects of health-related quality of life, hospital stay, overall & disease-free survival to 24 months. RECRUITMENT: We will use an integrated qualitative recruitment intervention using audio-recording of consultations between surgeons & patients to optimise recruitment. Screening logs will be used to record the numbers of patients referred for surgery, eligible for ROMIO, and randomised. We will use the information from screening logs and the qualitative data to train clinical teams to recruit. SAMPLE SIZE: 203 patients in each of the LAO and OO groups will allow a minimum clinically important difference of 0.4 standard deviations on the primary outcome to be detected with more than 90% power at the 5% significance level, allowing for 15% of patients not following their allocated procedure, & 10% failure to complete the primary outcome. THE LITERATURE: Our systematic review will be updated annually. TIMETABLE: 6 months set up, 40 months recruitment, 24 months follow-up, 6 months close out; hence 76 months in total TEAM: Surgeons & other clinical expertise, trial methodologists, research nurses and PPI. SUB-STUDY: Bristol/Bath and Southampton will also randomly allocate patients to a totally minimally invasive oesophagectomy, giving unbiased early information on this novel approach. Quality assurance of surgery will be monitored (Blencowe, N.S., et al., Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study. BMJ Open, 2019. 9(3): p. e026209). From Jan 2019, Southampton will not recruit any more patients to the sub-study.
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