Background: Robotic gastrectomy (RG) has been shown to be a safe and feasible method in gastric cancer (GC) treatment. However, most studies are in Eastern cohorts and there is great interest in knowing whether the method can be used routinely, especially in the West.
Objectives: The aim of this study was to compare the short-term surgical outcomes of D2-gastrectomy by RG versus open gastrectomy (OG).
Methods: Single-institution, open-label, non-inferiority, randomized clinical trial performed between 2015 and 2020. GC patients were randomized (1:1 allocation) to surgical treatment by RG or OG. Da Vinci Si platform was used.
Inclusion criteria: gastric adenocarcinoma, stage cT2-4 cN0-1, potentially curative surgery, age 18-80 years, and ECOG performance status 0-1.
Exclusion criteria: emergency surgery and previous gastric or major abdominal surgery. Primary endpoint was short-term surgical outcomes. The study is registered at clinicaltrials.gov (NCT02292914).
Results: Of 65 randomized patients, 5 were excluded (3 palliatives, 1 obstruction and emergency surgery, and 1 for material shortage). Consequently, 31 and 29 patients were included for final analysis in the OG and RG groups, respectively. No differences were observed between groups regarding age, sex, BMI, comorbidities, ASA, and frequency of total gastrectomy. RG had similar mean number of harvested lymph nodes (p = 0.805), longer surgical time (p < 0.001), and less bleeding (p < 0.001) compared to OG. Postoperative complications, length of hospital stay, and readmissions in 30 days were equivalent between OG and RG.
Conclusions: RG reduces operative bleeding by more than 50%. The short-term outcomes were non-inferior to OG, although surgical time was longer in RG.
Keywords: DaVinci system; Gastric cancer; Open surgery; Randomized clinical trial; Robotic surgery; Short-term surgical outcome.
© 2022. The Society for Surgery of the Alimentary Tract.