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

• Published in: Health technology assessment (Winchester, England) England), 2016-06, Vol.20 (48), p.1-68
• Main Authors: Metcalfe, Chris, Avery, Kerry, Berrisford, Richard, Barham, Paul, Noble, Sian M, Fernandez, Aida Moure, Hanna, George, Goldin, Robert, Elliott, Jackie, Wheatley, Timothy, Sanders, Grant, Hollowood, Andrew, Falk, Stephen, Titcomb, Dan, Streets, Christopher, Donovan, Jenny L, Blazeby, Jane M
• Format: Article
• Language: English
• Subjects: Aged; Esophageal Neoplasms - surgery; Esophagectomy - adverse effects; Esophagectomy - economics; Esophagectomy - methods; Feasibility Studies; feasibility study; Female; Humans; Length of Stay; Male; Middle Aged; minimally invasive; Minimally Invasive Surgical Procedures - adverse effects; Minimally Invasive Surgical Procedures - economics; Minimally Invasive Surgical Procedures - methods; oesophagectomy; Pain, Postoperative - epidemiology; Pilot Projects; pilot study; Postoperative Complications - epidemiology; Quality of Life; randomised controlled trial; Research Design; surgical procedures; upper gastrointestinal neoplasms
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta20480

Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. Pilot parallel three-arm randomised controlled trial nested within feasibility work. Two UK NHS departments of upper gastrointestinal surgery. Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients b