BACKGROUND: The feasibility of robot-assisted gastrectomy (RG) in terms of safety is unclear due to a lack of prospective studies. We showed feasible surgical outcomes in our previous study. In this phase II study, we assessed feasibility of the procedure by recruiting a larger number of patients. METHOD: This single-center, prospective phase II study included patients with clinical stage I gastric cancer undergoing RG. The primary end point was the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreas-related infection, and intra-abdominal abscess. The secondary end points were overall survival, relapse-free survival, RG completion rate, and incidence of all surgical morbidities. RESULTS: A total of 120 patients were recruited between December 2012 and April 2015. The incidence of intra-abdominal infectious complications was 3.3 % (95 % CI 0.9-8.3 %), and all complications were successfully treated conservatively without re-operation. The incidence of overall adverse events was 14.2 % (95 % CI 8.5-21.7 %). Three patients required conversion to open gastrectomy according to the protocol due to advancement of disease. CONCLUSION: Our data show that RG is safe in terms of the incidence and severity of postoperative complications.
BACKGROUND: The feasibility of robot-assisted gastrectomy (RG) in terms of safety is unclear due to a lack of prospective studies. We showed feasible surgical outcomes in our previous study. In this phase II study, we assessed feasibility of the procedure by recruiting a larger number of patients. METHOD: This single-center, prospective phase II study included patients with clinical stage I gastric cancer undergoing RG. The primary end point was the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreas-related infection, and intra-abdominal abscess. The secondary end points were overall survival, relapse-free survival, RG completion rate, and incidence of all surgical morbidities. RESULTS: A total of 120 patients were recruited between December 2012 and April 2015. The incidence of intra-abdominal infectious complications was 3.3 % (95 % CI 0.9-8.3 %), and all complications were successfully treated conservatively without re-operation. The incidence of overall adverse events was 14.2 % (95 % CI 8.5-21.7 %). Three patients required conversion to open gastrectomy according to the protocol due to advancement of disease. CONCLUSION: Our data show that RG is safe in terms of the incidence and severity of postoperative complications.
Entities:
Keywords:
Clinical trial; Gastrectomy; Gastric cancer; Robot; da Vinci
Authors: B W Eom; H M Yoon; K W Ryu; J H Lee; S J Cho; J Y Lee; C G Kim; I J Choi; J S Lee; M C Kook; J Y Rhee; S R Park; Y W Kim Journal: Eur J Surg Oncol Date: 2011-09-25 Impact factor: 4.424
Authors: Stefano Caruso; Alberto Patriti; Franco Roviello; Lorenzo De Franco; Franco Franceschini; Graziano Ceccarelli; Andrea Coratti Journal: World J Clin Oncol Date: 2017-06-10