Background: Laparoscopic gastrectomy (LG) has several benefits as a treatment of gastric cancer (GC), including reduced pain, early recovery of intestinal function, and shorter hospital stay. LG still has several drawbacks, however, including limited range of movement, amplification of hand tremors, and inconvenient surgical positioning. Around the peripancreatic area, laparoscopic lymph node dissection, therefore, remains challenging; postoperative pancreatic fistula occurs in around 4-7% of patients undergoing LG. Robotic surgery, on the other hand, plays a role in ergonomics and offers several advantages, including 7° of wrist-like motion, less fatigue, tremor filtering, motion scaling, and three-dimensional vision. In our previous retrospective study, we compared the safety and feasibility of surgical outcomes of LG and robotic gastrectomy (RG) for patients with GC. In our previous results, in the LG group, intra-abdominal infectious complications were found in 11%. In the RG group, however, none were found. Our RG procedure may be associated with decreased incidence of intra-abdominal infectious complications. Prospective randomized controlled trials (RCTs) comparing LG and RG are required, however. We begin an RCT to compare short-term surgical and long-term oncological outcomes of LG and RG for GC patients.
Methods: This is a randomized, single-center clinical trial. All included patients are adults with primary carcinoma of the stomach, in whom the tumor is considered surgically resectable (stages I-III). Included in this trial are 240 patients with GC. The primary endpoint is to assess the incidence of postoperative intra-abdominal infectious complications including pancreatic fistula, intra-abdominal abscess, and anastomotic leakage. Secondary endpoints include the incidence of any complications (both related and unrelated to surgery), surgical results, postoperative course, and oncological outcomes.
Discussion: Although its short-term outcomes have been proven comparable to LG in comparative studies, use of RG remains restricted, partly due to the lack of informative RCTs pertaining to it. To evaluate the surgical and oncological outcomes of RG, we therefore undertake a prospective RCT. The obtained results will be useful for reducing the restrictions and for adaptive expansion of RG for patients with GC.
Trial registration: University Hospital Medical Information Network Clinical Trials Registry, ID: UMIN000031536 . Registered on 1 March 2017.
Keywords: Gastric cancer; Laparoscopic gastrectomy; Minimally invasive surgery; Phase III clinical trial; Robotic gastrectomy.