Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial
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 we...
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| Published in: | British journal of surgery 2024-03, Vol.111 (3) |
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| Format: | Article |
| Language: | eng |
| Subjects: | |
| Online Access: | Get full text |
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| Summary: | 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.
This pragmatic randomized controlled trial conducted in eight UK centres allocated patients with localized oesophageal cancer to hybrid oesophagectomy with minimally invasive gastric mobilization and thoracotomy, or open surgery. The primary outcome was patient-reported recovery in the 3 months following allocation, measured using the EORTC QLQ-C30 physical function subscale. We found no evidence of a difference in recovery time between hybrid and open surgery, and a similar risk of key complications. |
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| ISSN: | 0007-1323 1365-2168 |