RA02.02: RANDOMISED OESOPHAGECTOMY: MINIMALLY INVASIVE OR OPEN: THE ROMIO STUDY

Abstract

Abstract Background Oesophagectomy is the mainstay of curative treatment for oesophageal cancer; however, surgery is followed by a reduction in health-related quality of life (HRQL). Whether minimally invasive approaches improve HRQL is unknown and limited comparative evidence available. The ROMIO study is a pragmatic multi-centre randomised controlled trial (RCT) aiming to establish the clinical and cost effectiveness of laparoscopically-assisted (LAO) versus open oesophagectomy (OO) in patients with oesophageal cancer in terms of HRQL, complications and survival. It includes an exploratory study of totally minimally invasive oesophagectomy (TMIO). Methods Adult participants referred for primary oesophagectomy or oesophagectomy following re-staging after neoadjuvant chemotherapy or chemoradiotherapy for oesophageal or oesophago-gastric adenocarcinoma or squamous cell cancer are eligible. Consenting patients are randomised 1:1 to receive OO or LAO except in two centres where participants are randomised to LAO, OO or TMIO (1:1:1). The primary outcome is the EORTC QLQ-C30 physical function scale, assessed at 3, 6 and 12 weeks after randomisation. Secondary outcomes include hospital stay, blinded assessment of pain, surgical complications, other aspects of HRQL and survival to 24 months. Quality assurance of surgery is assessed with, i) surgeon entry criteria based on provision of two operative videos, ii) 7 standard intra-operative photographs, and, iii) histopathological assessment of the specimen. A qualitative intervention is being used to train surgeons to recruit and communicate clinical equipoise. 406 patients are required to examine whether the minimum clinically important difference on the QLQ-C30 physical function scale is detected, allowing for 5% of patients allocated to LAO to undergo OO and a proportion to be inoperable or not followed up (90% power, 5% significance). This will also detect a clinically important reduction in length of stay. Results Seven UK centres involving 33 surgeons are recruiting. 288 patients have been screened, of which 206(73%) are eligible and 117(56%) eligible randomised. 21 surgeons have submitted at least two videos for assessment. Of the 102 patients operated on, 1058 photographs have been returned from 85 different patients. Follow up is currently at 79% for all time points. Conclusion This RCT will provide evidence to inform decision-making and informed consent for oesophagectomy. Disclosure All authors have declared no conflicts of interest.