Abstract
Recent guidelines recommend prolonged thromboprophylaxis after oesophagectomy due to cancer. However, no previous studies have examined if prolonged prophylaxis is superior to standard, in-hospital prophylaxis. We aimed to perform the first clinical, randomised study testing the efficacy of a prolonged, one-month thromboprophylaxis with low molecular weight heparin versus the standard treatment. The study was an open-label, randomised, controlled trial including patients undergoing oesophagectomy. The primary endpoint was the difference in prothrombin fragment 1+2 (F1+2) levels one month after surgery between the standard and the intervention group. The secondary endpoints were incidence of venous thromboembolic events and mortality. The study was terminated before reaching the expected sample size of 100 patients due to low accrual. We included 79 patients. At follow-up one month after surgery, F1+2 levels did not differ between the standard and the intervention group (p=0.41). Incidence of venous thrombosis was similar in the two groups with 13% in the standard and 15% in the intervention group. Preoperative F1+2 levels were significantly higher in patients who developed a venous thrombosis within one month after surgery than in those who did not (p=0.01). The odds ratio of VTE per 50 pmol/L increase in F1+2 was 1.64 (95% CI 1.17-2.54). No patients died within one month after surgery. No benefit of prolonged thromboprophylaxis after oesophagectomy was found. Preoperative F1+2 levels were found to be a predictor for incidence of postoperative thromboembolism.
Published Version
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