Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial

Objective: We investigated if hybrid oesophagectomy with minimally invasive gastric mobilisation and thoracotomy enabled faster recovery than open surgery.

Methods: In eight UK centres, this pragmatic randomised controlled trial recruited patients for oesophagectomy to treat localised 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. We present the intention-to-treat analysis of outcome measures from the first three months post-randomisation, 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 three months post-randomisation: difference in means 2.1, 95% confidence interval -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 three months.

Conclusions: Patient reported physical function in the three months post-randomisation provided no evidence of a difference in recovery time between hybrid and open surgery, nor 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.