• Wook Kim, Hyung-Ho Kim, Sang-Uk Han, Min-Chan Kim, Woo Jin Hyung, Seung Wan Ryu, Gyu Seok Cho, Chan Young Kim, Han-Kwang Yang, Do Joong Park, Kyo Young Song, Sang Il Lee, Seung Yub Ryu, Joo-Ho Lee, Hyuk-Joon Lee, and Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group.
• *Department of Surgery, Yeouido St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea †Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea ‡Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea §Department of Surgery, Dong-A University College of Medicine, Busan, Republic of Korea ¶Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea ||Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea **Department of Surgery, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea ††Department of Surgery, Chonbuk National University Hospital, Jeonju, Republic of Korea ‡‡Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea §§Department of Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea ¶¶Department of Surgery, Chungnam National University Hospital, Daejeon, Republic of Korea ||||Department of Surgery, Chonnam National University Medical School, Gwangju, Republic of Korea ***Department of Surgery, EwhaWomans University Mokdong Hospital, Seoul, Republic of Korea.
• Ann. Surg. 2016 Jan 1;263(1):28-35.

ObjectiveTo determine the safety of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea.BackgroundThere is still a lack of large-scale, multicenter randomized trials regarding the safety of LADG.MethodsA large-scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5-year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end pointResults: A total of 1416 patients were randomly assigned to the LADG group (n = 705) or the ODG group (n = 711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention-to-treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively). In the PP analysis, 6 patients (0.9%) needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0% vs 19.9%, P = 0.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs 7.7%, P < 0.001). The major intra-abdominal complication (7.6% vs 10.3%, P = 0.095) and mortality rates (0.6% vs 0.3%, P = 0.687) were similar between the 2 groups. Modified ITT analysis showed similar results with PP analysis.ConclusionsLADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG.

20 keywords...

hide…