Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial
Authors:   The ROMIO Study Group, Akhtar Khurshid , Alkhaffaf Bilal , Ariyarathenam Arun , Avery Kerry , Barham Paul , Bateman Adrian , Beard Chloe , Berrisford Richard , Blazeby Jane M , Blencowe Natalie , Boddy Alex , Bowrey David , Bracey Tim , Brierley Rachel C , Briton Kate , Byrne James , Catton James , Chaparala Ram , Clark Sarah K , Clarke Tonia , Cooke Jill , Couper Graeme , Culliford Lucy , Dawson Heidi , Deans Chris , Donovan Jenny L , Ekblad Charlotte , Elliott Jackie , Exon David , Falk Stephen , Farooq Naheed , Garfield Kirsty , Gaunt Daisy M , Gill Fran , Goldin Robert , Gravani Athanasia , Hanna George , Hayes Stephen , Heys Rachael , Hindmarsh Carolyn , Hollinghurst Sandra , Hollingworth William , Hollowood Andrew , Houlihan Rebecca , Howes Benjamin , Howie Lucy , Humphreys Lee , Hutton David , Jarvis Rosina , Jepson Marcus , Kandiyali Rebecca , Kaur Surinder , Kaye Philip , Kelly Jamie , King Anni , Kirwin Jana , Krysztopik Richard , Lamb Peter , Lang Alistair , Lee Vivienne , Maitland Sally , Mapstone Nicholas , Melia Georgia , Metcalfe Chris , Melhado Rachel , Moure-Fernandez Aida , Nair Beena , Nicklin Joanna , Noble Fergus , Noble Sian M , O’Connell Abby , Palmer Stephen , Parsons Simon , Pursnani Kish , Rea Nicola , Reed Fiona , Rice Caoimhe , Richards Cathy , Rogers Chris , Sanders Grant , Save Vicki , Shaw Chas , Schiller Michael , Schranz Rachel , Shetty Vinutha , Shirkey Beverly , Singleton Jo , Skipworth Richard , Smith Joanne , Streets Christopher , Titcomb Dan , Turner Paul , Ubhi Sukhbir , Underwood Tim , Vinod Cellins , Vohra Ravinder , Ward Elizabeth M , Warman Rhian , Welch Neil , Wheatley Tim , White Katie , Wickens Robin A , Wilkerson Paul , Williams Alexandra , Williams Rob , Wilmshurst Natasha , Wong Newton A C S 
Published: March 2024

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.