Abstract
ObjectiveTo determine risk factors for early postoperative complications after D3 dissection for stage II/III colon cancer.BackgroundIdentification 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.MethodsProportion 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.ResultsAmong 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.ConclusionOpen 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.)
Highlights
Preoperative identification and evaluation of risk factors for postoperative complications of colon cancer patients who undergo surgery would assist with informed consent for treatment, consideration of treatment options, and identification of high-risk cases for special and possibly multidisciplinary attention
We aimed to identify the risk factors for postoperative early complications in patients with stage II and III colon cancer by exploratory analyses using the data from JCOG0404
Eligibility criteria of JCOG0404 included histologically proven colon cancer with histologically confirmed adenocarcinoma, signet ring cell carcinoma, or adenosquamous carcinoma; tumor located in the cecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesion without involvement of other organs, N0-2 and M0; tumor size ≤8 cm; and age 20-75 years
Summary
Preoperative identification and evaluation of risk factors for postoperative complications of colon cancer patients who undergo surgery would assist with informed consent for treatment, consideration of treatment options, and identification of high-risk cases for special and possibly multidisciplinary attention. Few reports have evaluated such risk factors of colon cancer surgery requiring D3 lymph node dissection, and those that have were small-scale and retrospective studies. Risk factors such as age and long operation time did not always conform to each result.[1,2]. JCOG0404 was a randomized controlled trial (RCT) conducted by the Colorectal Cancer Study Group of the Japan Clinical Oncology Group (JCOG) to confirm the non-inferiority of laparoscopic surgery (LAP) in comparison with open surgery (OP) for patients with stage II/III colon cancer in terms of overall survival (OS) according to current practices. JCOG0404 enrolled more than 1000 patients, making it one of the largest RCT for patients with colon cancer requiring D3 dissection in Japan
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