Summary. Background: Patients undergoing major abdominal surgery carry a high risk of venous thromboembolism (VTE), but the optimal duration of postoperative thromboprophylaxis is unknown. Objectives: To evaluate the efficacy and safety of thromboprophylaxis with the low molecular weight heparin (dalteparin), administered for 28 days after major abdominal surgery compared to 7 daysÕ treatment. Patients/Methods: A multicenter, prospective, assessor-blinded, open-label, randomized trial was performed in order to evaluate prolonged thromboprophylaxis after major abdominal surgery. In total, 590 patients were recruited, of whom 427 were randomized and received at least 1 day of study medication, and 343 reached an evaluable endpoint. The primary efficacy endpoint was objectively verified VTE occurring between 7 and 28 days after surgery. All patients underwent bilateral venography at day 28. Results: The cumulative incidence of VTE was reduced from 16.3% with short-term thromboprophylaxis (29/178 patients) to 7.3% after prolonged thromboprophylaxis (12/ 165) (relative risk reduction 55%; 95% confidence interval 15-76; P ¼ 0.012). The number that needed to be treated to prevent one case of VTE was 12 (95% confidence interval 7-44). Bleeding events were not increased with prolonged compared with short-term thromboprophylaxis. Conclusions: Four-week administration of dalteparin, 5000 IU once daily, after major abdominal surgery significantly reduces the rate of VTE, without increasing the risk of bleeding, compared with 1 week of thromboprophylaxis.
Allowing patients to eat normal food at will from the first day after major upper GI surgery does not increase morbidity compared with traditional care with nil-by-mouth and enteral feeding.
The optimal administration regimens of low molecular weight heparins (LMWHs) have not yet been established. The aim of this study was to compare the efficacy and safety of 2500 and 5000 XaI units of the LMWH dalteparin in patients undergoing elective general surgery for malignant and benign abdominal disease. Prophylaxis was started in the evening before surgery and given once-daily every evening thereafter. The study was designed as a prospective, randomized, double-blind, multicentre trial. Some 66.4 per cent of patients were operated on for a malignant disorder. The primary endpoint was deep vein thrombosis (DVT) detected with the fibrinogen uptake test. Bleeding complications were recorded and classified. Analysis was made both on an intention to treat basis and in patients given correct prophylaxis (86.3 per cent). A total of 2097 patients were randomized and 27 excluded after randomization. A technically correct fibrinogen uptake test was obtained in 1957 patients. The incidence of DVT was significantly lower in patients given 5000 XaI units, this being true for both correct prophylaxis (6.8 versus 13.1 per cent, P < 0.001), on an intention to treat basis (6.6 versus 12.7 per cent, P < 0.001), and in patients with malignant disease (8.5 versus 14.9 per cent, P < 0.001). Sixty-seven patients (3.2 per cent) died within 30 days with no difference between the groups. There were two cases of fatal pulmonary embolism. The frequency of bleeding complications in the whole series was higher in patients randomized to 5000 XaI units (4.7 versus 2.7 per cent, P = 0.02), although this was not the case in those operated on for malignant disease (4.6 versus 3.6 per cent, P not significant). Dalteparin in the dose of 5000 XaI units started in the evening before surgery has a good thromboprophylactic effect in high-risk general surgery at the cost of a small bleeding risk. In patients with malignant disease there was no increased risk of bleeding. The overall frequency of fatal pulmonary embolism with dalteparin is extremely low, even in this high-risk group of patients.
After radical surgery for rectal adenocarcinoma, the presence of venous and neural invasion of tumor cells was correlated with the pattern of treatment failure, local in the pelvis or distant. Of 128 operation specimens, venous and neural invasion was demonstrated in 22 percent and 32 percent, respectively. A significant decrease of the distant recurrence-free 5-year survival (Kaplan-Meier method) was seen when venous invasion was demonstrated (32.9 percent vs. 84.3 percent; P less than 0.0001), whereas more local failures were registered in patients with neural invasion. The local recurrence-free 5-year survival in patients with neural invasion was 64.3 percent, compared with 81.1 percent when neural invasion was not demonstrated (P = 0.03). Their prognostic value was then studied in a Cox regression model including stage and grade. Neural invasion had the strongest association with local recurrences, whereas venous invasion was found to be the third strongest independent predictor of metastasis, after lymph node status and extent of local tumor infiltration. We conclude that examining for the presence of venous and neural invasion gives reliable prediction of recurrences after radical resection of rectal cancer. Recording of tumor recurrence pattern may lead to a better selection of patients for adjuvant therapy after surgery.
The aim of this study was to evaluate the 1-year results of single-session sclerotherapy of symptomatic benign non-parasitic liver cysts performed with maximum 10 min time of ethanol exposure. During the period 1995-1999, 15 symptomatic liver cysts in nine patients--eight women and one man--were treated with 10 min time of exposure to ethanol. Ultrasound-guided puncture combined with fluoroscopy was used for catheter placement. Alcohol sclerotherapy was performed with a maximum volume of ethanol 96% of 10% of the cyst volume, never exceeding 100 ml. At follow-up the patients were examined with liver function tests, ultrasound or CT examination, clinical examination, and interview by a gastrointestinal surgeon. Ten cysts in seven patients (six women and one man; age range 44-61 years, median age 58 years), who had a follow-up of at least 1 year, were included. The original cyst volumes were 30-4110 ml (median 392 ml). After a follow-up period of 12-47 months (median 23 months), cyst volumes were 0-523 ml (median 21.5 ml) with a reduction of the median cyst volume by 95% ( p<0,005). All patients experienced relief of their clinical symptoms. Except for pain, no complications were observed. Sclerotherapy using only one session and maximum 10 min time of exposure to ethanol represents an effective treatment of symptomatic liver cysts.
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