ROMIO
Trial question
What is the role of hybrid surgery in patients with esophageal cancer?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
15.0% female
85.0% male
N = 533
533 patients (81 female, 452 male).
Inclusion criteria: adult patients referred for esophagectomy to treat localized cancer.
Key exclusion criteria: high-grade dysplasia; cancer spread beyond the esophagus; or any stage with M1.
Interventions
N=267 hybrid surgery (laparoscopic esophagectomy with minimally invasive gastric mobilization and thoracotomy).
N=266 open surgery (location and length of incisions at the surgeon's discretion, with transhiatal and thoracoabdominal approaches prohibited).
Primary outcome
Mean physical function at 3 months
69
68
69.0
51.8
34.5
17.3
0.0
Hybrid
surgery
Open
surgery
No significant
difference ↔
No significant difference in mean physical function at 3 months (69 vs. 68; AD 2.3 , 95% CI -1.7 to 6.4).
Secondary outcomes
No significant difference in median postoperative hospital stay (11 days vs. 10 days; AD 1 days, 95% CI -0.12 to 2.12).
No significant difference in the rate of death within 90 days after surgery (3.1% vs. 5.4%; RR 0.57, 95% CI -0.29 to 1.43).
No significant difference in the rate of death within 30 days after surgery (1.5% vs. 2.3%; RR 0.65, 95% CI -1.33 to 2.63).
Safety outcomes
No significant difference in complications.
Conclusion
In adult patients referred for esophagectomy to treat localized cancer, hybrid surgery was not superior to open surgery with respect to mean physical function at 3 months.
Reference
ROMIO Study Group. Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial. Br J Surg. 2024 Mar 2;111(3):znae023.
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