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Ann Surg. 2014 Jul;260(1):23-30. doi: 10.1097/SLA.0000000000000499.

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.

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  • 1*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.

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.

PMID:
24509190
[PubMed - indexed for MEDLINE]
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