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Purpose: To investigate the safety and efficacy of fondaparinux (FPX) for venous thromboembolism (VTE) prophylaxis in Japanese patients undergoing colorectal cancer surgery. Methods: The subjects of this multicenter, open-label, prospective observational study were patients undergoing resection of the colon/rectum for colorectal cancer. All patients were given FPX 2.5 or 1.5 mg by subcutaneous injection, once daily for 4-8 days, starting 24 h after surgery. The primary endpoint was any major bleeding event and the secondary endpoint was any symptomatic VTE event. Results: Between February 2009 and December 2010, 619 patients from 23 institutions were enrolled in this study. The median duration of FPX prophylaxis was 4 days. The incidence of major bleeding was 0.81 % [5/619, 95 % confidence interval (CI) 0.3-1.9] and the incidence of minor bleeding was 9.5 % (59/619, 95 % CI 7.3-12.1). There was no fatal bleeding or symptomatic VTE. Multivariable analysis revealed the following to be risk factors for bleeding events: preoperative platelet count <15 × 10/µl [odds ratio (OR) 4.521], male sex (OR 2.078), and blood loss during surgery <50 ml (OR 2.019). Conclusion: The administration of 2.5/1.5 mg FPX 24 h after colorectal cancer surgery is safe and effective. [ABSTRACT FROM AUTHOR]

Purpose: Postoperative pain management is important for enhanced recovery. High-dose oral acetaminophen is effective; however, the safety of its long-term use has not been established in gastrointestinal surgeries. This study aimed to investigate drug-induced liver injury (DILI) in patients with colorectal cancer using high-dose acetaminophen.One hundred sixty-eight consecutive colorectal cancer using high-dose oral acetaminophen (3600 mg/day between postoperative day 1 and 7) were enrolled.One hundred forty-nine patients (88.7%) completed the administration of high-dose oral acetaminophen. DILI occurred in 58 patients (34.5%), and the cumulative incidence rates were 20.4% and 37.9% on postoperative 6 and 7, respectively. The severity of liver injury was grade 1 in all cases and returned to normal without treatment. Patients with DILI had a higher frequency of dyslipidemia (44.8% vs. 23.6%, P = 0.0047) and M1 staging (10.3% vs. 1.0%, P = 0.0036). A multivariate analysis showed that the presence of dyslipidemia (OR 2.61, P = 0.0067) and M1 stage (OR 12.4, P = 0.0053) were independent risk factors for DILI.The long-term use of high-dose oral acetaminophen in colorectal cancer patients enrolled in enhanced recovery protocols is feasible. Moreover, the presence of dyslipidemia and M status are risk factors for DILI.Methods: Postoperative pain management is important for enhanced recovery. High-dose oral acetaminophen is effective; however, the safety of its long-term use has not been established in gastrointestinal surgeries. This study aimed to investigate drug-induced liver injury (DILI) in patients with colorectal cancer using high-dose acetaminophen.One hundred sixty-eight consecutive colorectal cancer using high-dose oral acetaminophen (3600 mg/day between postoperative day 1 and 7) were enrolled.One hundred forty-nine patients (88.7%) completed the administration of high-dose oral acetaminophen. DILI occurred in 58 patients (34.5%), and the cumulative incidence rates were 20.4% and 37.9% on postoperative 6 and 7, respectively. The severity of liver injury was grade 1 in all cases and returned to normal without treatment. Patients with DILI had a higher frequency of dyslipidemia (44.8% vs. 23.6%, P = 0.0047) and M1 staging (10.3% vs. 1.0%, P = 0.0036). A multivariate analysis showed that the presence of dyslipidemia (OR 2.61, P = 0.0067) and M1 stage (OR 12.4, P = 0.0053) were independent risk factors for DILI.The long-term use of high-dose oral acetaminophen in colorectal cancer patients enrolled in enhanced recovery protocols is feasible. Moreover, the presence of dyslipidemia and M status are risk factors for DILI.Results: Postoperative pain management is important for enhanced recovery. High-dose oral acetaminophen is effective; however, the safety of its long-term use has not been established in gastrointestinal surgeries. This study aimed to investigate drug-induced liver injury (DILI) in patients with colorectal cancer using high-dose acetaminophen.One hundred sixty-eight consecutive colorectal cancer using high-dose oral acetaminophen (3600 mg/day between postoperative day 1 and 7) were enrolled.One hundred forty-nine patients (88.7%) completed the administration of high-dose oral acetaminophen. DILI occurred in 58 patients (34.5%), and the cumulative incidence rates were 20.4% and 37.9% on postoperative 6 and 7, respectively. The severity of liver injury was grade 1 in all cases and returned to normal without treatment. Patients with DILI had a higher frequency of dyslipidemia (44.8% vs. 23.6%, P = 0.0047) and M1 staging (10.3% vs. 1.0%, P = 0.0036). A multivariate analysis showed that the presence of dyslipidemia (OR 2.61, P = 0.0067) and M1 stage (OR 12.4, P = 0.0053) were independent risk factors for DILI.The long-term use of high-dose oral acetaminophen in colorectal cancer patients enrolled in enhanced recovery protocols is feasible. Moreover, the presence of dyslipidemia and M status are risk factors for DILI.Conclusion: Postoperative pain management is important for enhanced recovery. High-dose oral acetaminophen is effective; however, the safety of its long-term use has not been established in gastrointestinal surgeries. This study aimed to investigate drug-induced liver injury (DILI) in patients with colorectal cancer using high-dose acetaminophen.One hundred sixty-eight consecutive colorectal cancer using high-dose oral acetaminophen (3600 mg/day between postoperative day 1 and 7) were enrolled.One hundred forty-nine patients (88.7%) completed the administration of high-dose oral acetaminophen. DILI occurred in 58 patients (34.5%), and the cumulative incidence rates were 20.4% and 37.9% on postoperative 6 and 7, respectively. The severity of liver injury was grade 1 in all cases and returned to normal without treatment. Patients with DILI had a higher frequency of dyslipidemia (44.8% vs. 23.6%, P = 0.0047) and M1 staging (10.3% vs. 1.0%, P = 0.0036). A multivariate analysis showed that the presence of dyslipidemia (OR 2.61, P = 0.0067) and M1 stage (OR 12.4, P = 0.0053) were independent risk factors for DILI.The long-term use of high-dose oral acetaminophen in colorectal cancer patients enrolled in enhanced recovery protocols is feasible. Moreover, the presence of dyslipidemia and M status are risk factors for DILI. [ABSTRACT FROM AUTHOR]