title: Short-term surgical outcomes from a randomized controlled trial to evaluate laparoscopic and open D3 dissection for stage II/III colon cancer: Japan Clinical Oncology Group Study JCOG 0404.
abstract: OBJECTIVE
  A randomized controlled trial to confirm the non-inferiority of laparoscopic surgery to open surgery in terms of overall survival was conducted, and short-term surgical outcomes are demonstrated.
  
  
  BACKGROUND
  The efficacy and safety outcome of laparoscopic surgery for clinical stages II/III colon cancer undergoing Japanese D3 dissection are still unclear.
  
  
  METHODS
  Eligibility criteria included colon cancer; tumor located in the cecum, ascending, sigmoid, or rectosigmoid colon; T3 or T4 without involvement of other organs; N0-2; and M0. Patients were randomized preoperatively and underwent tumor resection with D3 dissection. Safety analyses were conducted by per-protocol set.
  
  
  RESULTS
  A total of 1057 patients were randomized between October 2004 and March 2009. By per-protocol set, 524 patients who underwent open surgery and 533 patients who underwent laparoscopic surgery were analyzed. D3 dissection was performed in 521 (99.4%) patients in the open surgery arm and 529 (99.2%) patients in the laparoscopic surgery arm. Conversion to open surgery was needed for 29 (5.4%) patients. Patients assigned to laparoscopic surgery had less blood loss (P < 0.001), although laparoscopic surgery lasted 52 minutes longer (P < 0.001). Laparoscopic surgery was associated with a shorter time to pass first flatus, decreased use of analgesics after 5 postoperative days, and a shorter hospital stay. Morbidity [14.3% (76/533) vs 22.3% (117/524), P < 0.001] was lower in the laparoscopic surgery arm.
  
  
  CONCLUSIONS
  Short-term surgical safety and clinical benefits of laparoscopic D3 dissection were demonstrated. The primary endpoint will be reported after the primary analysis, planned for 2014.
authors: *Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan; †Department of Gastroenterological Surgery, Oita University Faculty of Medicine, Oita, Japan; ‡JCOG Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo, Japan; §Department of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan; ¶Department of Surgical Oncology, Tokyo Medical and Dental University, Tokyo, Japan; and ‖Department of Surgery, Kitasato University Hospital, Kanagawa, Japan.
authors: Seiichiro
authors: S
authors: Yamamoto
authors: Masafumi
authors: M
authors: Inomata
authors: Hiroshi
authors: H
authors: Katayama
authors: Junki
authors: J
authors: Mizusawa
authors: Tsuyoshi
authors: T
authors: Etoh
authors: Fumio
authors: F
authors: Konishi
authors: Kenichi
authors: K
authors: Sugihara
authors: Masahiko
authors: M
authors: Watanabe
authors: Yoshihiro
authors: Y
authors: Moriya
authors: Seigo
authors: S
authors: Kitano
mesh_terms: D003082:Colectomy / Q000379:methods*; D003110:Colonic Neoplasms / Q000401:mortality / Q000556:secondary / Q000601:surgery*; D003113:Colonoscopy; D005500:Follow-Up Studies; D017052:Hospital Mortality / Q000639:trends; D007564:Japan / Q000453:epidemiology; D010535:Laparoscopy; D007902:Length of Stay / Q000639:trends; D008197:Lymph Node Excision / Q000379:methods*; D008207:Lymphatic Metastasis; D009367:Neoplasm Staging; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome