Abstract
OBJECTIVE: To determine risk factors for early postoperative complications after D3 dissection for stage II/III colon cancer. BACKGROUND: Identification of risk factors for postoperative complications is essential in patients surgically treated for colon cancer. The Japan Clinical Oncology Group (JCOG) conducted a randomized controlled trial, JCOG0404, to confirm the non-inferiority of laparoscopic surgery (LAP) to open surgery (OP) with D3 dissection for stage II/III colon cancer. This supplementary analysis was made to assess risk factors for surgery requiring D3 dissection using data from JCOG0404. METHODS: Proportion of postoperative complications of any grade (CTCAE ver. 3.0) until first discharge and risk factors for the most frequent complications were analyzed by univariable and multivariable analysis. RESULTS: Among 1057 randomized patients treated between October 2004 and March 2009, 520 patients with OP and 525 patients with LAP were analyzed. Overall postoperative complications of all grades occurred in 190 patients (18.2%). Multivariable analysis showed that the risk factors for overall early postoperative complications were OP itself (odds ratio [OR] 2.01, 95% confidence interval [CI]: 1.38-2.91, P = 0.0003) and operation time of >240 minutes (OR 1.94, 95% CI: 1.24-3.02, P = 0.0036). The most frequent adverse event was wound complication (50/1045, 4.8%). In the univariable analysis, reconstruction, greater blood loss, OP, and higher body mass index were significantly associated with wound complication. CONCLUSION: Open surgery and longer operation time of >240 minutes were significant risk factors for postoperative complications. LAP surgery and shorter operation time could contribute to fewer postoperative complications in patients undergoing colectomy with D3 dissection. (Japan Clinical Oncology Group study JCOG 0404: NCT00147134/UMIN-CTR: C000000105.).