• Kei Hosoda, Hiroaki Mieno, Akira Ema, Hideki Ushiku, Marie Washio, Ildae Song, Masahiko Watanabe, and Keishi Yamashita.
• Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: k.hosoda@kitasato-u.ac.jp.
• J. Surg. Res. 2019 Jun 1; 238: 224-231.

BackgroundConventional laparoscopic and open distal gastrectomy procedures have inherent limitations such as restricted movement of straight forceps and tremor of the tip of the devices that can potentially be overcome using robotic distal gastrectomy (RDG). This single-institutional phase II trial aimed to evaluate the safety and feasibility of RDG with lymph node dissection for clinical stage IA gastric cancer.MethodsThe study included patients with clinical stage IA gastric cancer in the lower two-thirds of the stomach considered to be curatively resected via distal gastrectomy. The primary end point was the proportion of patients who developed intra-abdominal complications, requiring medical or interventional treatment. The planned sample size was 25, calculated based on an expected complication rate of 3% and a threshold complication rate of 15%, with a one-sided alpha of 10%, power of 70%.ResultsOverall postoperative complications rate was 16%. The proportion of patients who developed intra-abdominal complications, requiring treatment was 0% (90% confidence interval, 0-9.8%). No patient developed in-hospital adverse events of grade 3 or higher. The short-term clinical outcomes were as follows: the median duration of postoperative hospital stay was 7 d, and 10 patients (40.0%) had a body temperature of 38°C or higher during their hospital stay.ConclusionsThis trial confirmed the safety of RDG with limitation by the restriction of dedicated surgeons. A phase III trial to confirm the superiority of RDG to conventional laparoscopic distal gastrectomy is warranted.Copyright © 2019 Elsevier Inc. All rights reserved.

33 keywords...

hide…