Risk factors for early postoperative complications after D3 dissection for stage II or III colon cancer: Supplementary analysis of a multicenter randomized controlled trial in Japan (JCOG0404)

Yusuke Nishizawa, Tomonori Akagi, Masafumi Inomata, Hiroshi Katayama, Junki Mizusawa, Seiichiro Yamamoto, Masaaki Ito, Tadahiko Masaki, Masahiko Watanabe, Yasuhiro Shimada, Seigo Kitano, Yusuke Nishizawa, Tomonori Akagi, Masafumi Inomata, Hiroshi Katayama, Junki Mizusawa, Seiichiro Yamamoto, Masaaki Ito, Tadahiko Masaki, Masahiko Watanabe, Yasuhiro Shimada, Seigo Kitano

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.).

Keywords: D3; colon cancer; multivariate analysis; postoperative complication; risk factor.

Figures

Figure 1
Figure 1
Total of 1057 patients from 30 Japanese centers were randomized to the open surgery (OP) group (528 patients) or to the laparoscopic surgery (LAP) group (529 patients). Treatment assignment was balanced with respect to baseline characteristics. In the 528 patients assigned to OP, 8 patients underwent LAP. In contrast, among the 529 patients assigned to LAP, 4 patients underwent OP. Finally, 520 patients underwent OP and 525 patients underwent LAP, and the results were compared and analyzed

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