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.
A randomized controlled trial to confirm the noninferiority of laparoscopic surgery to open surgery for colon cancer was conducted. Accredited surgeons from 30 institutions in Japan participated and 1057 patients were registered. Short-term surgical safety and clinical benefits of laparoscopic D3 dissection were demonstrated.
*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.
Reprints: Dr Masafumi Inomata, Department of Gastroenterological Surgery, Oita University Faculty of Medicine, 1-1, Idaigaoka, Hasama-machi, Yufu, Oita 879-5593, Japan. E-mail: email@example.com.
Disclosure: This study has been supported by the National Cancer Center Research and Development Fund, Grant-in-Aid for Cancer Research, Health and Labour Sciences Research Grant for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan. The authors declare no conflict of interest.
Trial registration: ClinicalTrials.gov, number NCT00147134, and UMIN-CTR, number C000000105.