Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan;
Toshiyasu Ojima , Keiji Hayata , Junya Kitadani , Taro Goda , Shinta Tominaga , Masaki Ohi , Hiroki Yamaue , Manabu Kawai
Background: Robotic gastrectomy (RG) procedure for gastric cancer (GC) patients may be associated with decreased incidence of intra-abdominal infectious complications. Prospective randomized controlled trials (RCTs) comparing laparoscopic gastrectomy (LG) and RG are required, however. We completed an RCT to compare short-term surgical outcomes of LG and RG for GC patients. Methods: This was a randomized, two-center clinical trial. All included patients are adults with primary carcinoma of the stomach, in whom the tumor is considered surgically resectable (cStage I-III). Included in this trial were 240 patients with GC. The primary endpoint was to assess the incidence of postoperative intra-abdominal infectious complications including pancreatic fistula, intra-abdominal abscess, and anastomotic leakage. Secondary endpoints included incidence of postoperative complications, surgical results, postoperative course, and oncological outcomes. Lymphadenectomy without touching the pancreas was basically performed during robotic gastrectomy using assisting articulating forceps. Results: A total of 241 patients were randomly assigned to the LG group (n = 122) or the RG group (n = 119), and 236 patients (LG119 RG117) were analyzed for ITT population. Overall incidence of intra-opereative infectious complications higher than Clavien-Dindo grade II were not significantly different (LG 8.4%, RG 6%). However, overall incidence of any complications higher than grade II were significantly lower in the RG group (19.3 vs 8.5% P = .019). In RG group, postoperative pancreatic fistula was not found. Amylase levels in drainage fluid on POD 1 were significantly lower in the RG group (893IU/L) than in the LG group (438 IU/L) (P = 0.039). Conclusions: Regarding short-term surgical outcomes, RG is feasible, safe and ideal treatment procedure for GC. Our RG procedure without touching the pancreas may be associated with decreased incidence of postoperative pancreatic fistula. Clinical trial information: UMIN000031536.
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