Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial
The ROMIO Study Group, Khurshid Akhtar, Bilal Alkhaffaf, Arun Ariyarathenam, Kerry Avery, Paul Barham, Adrian Bateman, Chloe Beard, Richard Berrisford, Jane Blazeby, Natalie Blencowe, Alex Boddy, David Bowrey, Tim Bracey, Rachel Brierley, Kate Briton, James V. Byrne, James Catton, Ram Chaparala, Sarah K Clark, T. Howard Clarke, Jill Cooke, Graeme Couper, Lucy Culliford, Heidi Dawson, Chris Deans, Jenny Donovan, Charlotte Ekblad, Daisy Elliott, David Exon, Stephen Falk, Naheed Farooq, Kirsty Garfield, Daisy Gaunt, Fran Gill, Robert Goldin, Athanasia Gravani, George Hanna, Stephen J. Hayes, Rachael Heys, Carolyn Hindmarsh, Sandra Hollinghurst, William Hollingworth, Andrew Hollowood, Rebecca Houlihan, Benjamin H.L. Howes, Lucy Howie, Lee Humphreys, David Hutton, Rosina Jarvis, Marcus Jepson, Rebecca Kandiyali, Surinder Kaur, Philip Kaye, Jamie Kelly, Anni King, Jana Kirwin, Richard Krysztopik, Peter Lamb, A. M. Lang, Vivienne Lee, Sally Maitland, N Mapstone, Georgia Melia, Chris Metcalfe, Rachel Melhado, Aída Moure-Fernández, Beena Nair, Joanna Nicklin, Fergus Noble, Sian Noble, Abby O’Connell, Stephen Palmer, Simon L. Parsons, Kish Pursnani, Nicola Rea, Fiona Reed, Caoimhe Rice, Cathy Richards, Chris Rogers, Grant Sanders, Vicki Save, Chas Shaw, Michael Schiller, Rachel Schranz, Vinutha Shetty, Beverly A. Shirkey, Jo Singleton, Richard J. E. Skipworth, Joanne Smith, Christopher G. Streets, Dan Titcomb, Paul Turner, S. S. Ubhi, Tim Underwood, Cellins Vinod, Ravinder Vohra, Elizabeth Ward, Rhian Warman, Neil T. Welch
Abstract
OBJECTIVE: This study investigated if hybrid oesophagectomy with minimally invasive gastric mobilization and thoracotomy enabled faster recovery than open surgery. METHODS: In eight UK centres, this pragmatic RCT recruited patients for oesophagectomy to treat localized cancer. Participants were randomly allocated to hybrid or open surgery, stratified by centre and receipt of neoadjuvant treatment. Large dressings aimed to mask patients to their allocation for six days post-surgery. The authors present the intention-to-treat analysis of outcome measures from the first 3 months post-randomization, including the primary outcome, the patient-reported physical function scale of the EORTC QLQ-C30, and cost-effectiveness. Current Controlled Trials registration: ISRCTN 59036820 (feasibility study), 10386621 (definitive study). FINDINGS: There was no evidence of a difference between hybrid (n = 267) and open (n = 266) surgery in average physical function over 3 months post-randomization: difference in means 2.1, 95% c.i. -2.0 to 6.2, P = 0.3. Complication rates were similar; for example, 88 (34%) participants in the open and 82 (32%) participants in the hybrid surgery groups experienced a pulmonary infection within 30 days. There was no evidence that hybrid surgery was more cost-effective than open surgery at 3 months. CONCLUSIONS: Patient-reported physical function in the 3 months post-randomization provided no evidence of a difference in recovery time between hybrid and open surgery, or a difference in cost-effectiveness. Both approaches to surgery were completed safely, with a similar risk of key complications, suggesting that surgeons who have a preference for one of the two approaches need not change their practice.