SHORT-TERM SURGICAL OUTCOMES OF ROBOTIC GASTRECTOMY COMPARED TO OPEN GASTRECTOMY FOR PATIENTS WITH GASTRIC CANCER: A RANDOMIZED TRIAL
Ulysses Ribeiro*1,2, Andre Roncon Dias1,2, Marcus F. Ramos1,2, Osmar K. Yagi1,2, Rodrigo J. De Oliveira1,2, Ricardo Z. Abdalla1,2, Marina A. Pereira1,2, Bruno Zilberstein2, Sergio C. Nahas1,2, Ivan Cecconello1,2
1Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, SP, Brazil; 2Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil
Background: Robot-assisted gastrectomy is becoming more popular worldwide and has been shown to be a safe and feasible method in the treatment of gastric cancer (GC). However, most studies are in Eastern cohorts and due to differences in patient characteristics, including body mass index (BMI) and TNM stage, 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 robotic and open access.
Methods: This is an open-label, single-institution clinical trial performed between 2014 and 2021. GC patients were randomized (1:1 allocation) to receive surgical treatment by robotic (RG) or open (OG) gastrectomy. Da Vinci Si platform was used. Inclusion criteria were: gastric adenocarcinoma, stage cT2-4 cN0-1, surgery with potentially curative intent, age 18-80 years, ECOG performance status 0-1. Exclusion criteria were: emergency surgery, previous gastric surgery or major abdominal surgery. Primary outcome was operative bleeding. The hypothesis was that there is a 50% reduction in blood loss with RG. As the mean bleeding in the open surgery is 250ml, with a type I error of 0.05 and a study power of 90%, the sample was calculated to 30 patients in each group. The study is registered at clinicaltrials.gov (NCT02292914).
Results: Of 65 randomized patients, 5 were excluded (3 palliatives, 1 with 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 (Figure 1). No differences were observed between the groups regarding age, sex, BMI, comorbidities, ASA and frequency of total gastrectomy (Table 1). RG had similar mean number of dissected lymph nodes (p=0.805), a longer time of surgery (p<0.001), and less bleeding (p<0.001) compared to OG group. Postoperative complications, length of hospital stay and readmissions in 30-d were equivalent between OG and RG.
Conclusions: RG reduces operative bleeding by more than 50%. The short-term results are similar to OG, although surgical time was longer in RG.
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