PREVENTION OF VENOUS THROMBOEMBOLISM IN P ATIENTS UNDERGOING MINIMALLY INVASIVE SURGERY WITH A SHORT-TERM HOSPITAL STAY - RESULTS OF A MULTICENTRIC, PROSPECTIVE, RANDOMIZED, CONTROLLED CLINICAL-TRIAL WITH A LOW-MOLECULAR-WEIGHT HEPARIN

A prospective, randomised, controlled clinical trial was carried out i n order to elucidate the incidence of venous thromboembolism in select ed patients undergoing laparoscopic cholecystectomy and other types of minimally invasive surgery, as well as to show safety and efficacy of a low-molecular-weight heparin (LMWH) in the prevention of post-opera tive venous thromboembolism. Seven hundred and eighteen patients were randomly allocated to one of two groups: One group received physical m easures for prevention of deep-vein thrombosis, i.e. graduated elastic stockings (n = 359). The second group also received graduated elastic stockings and, additionally, a LMWH (reviparin sodium, Clivarin) SC o nce daily (n = 359). For safety reasons, with respect to the untreated control group, patients with three or more risk factors for venous th romboembolism were not included into the trial. Diagnosis for DVT was systematically done by duplex scan. In this, rather artificial low-ris k selection the overall incidence of thromboembolic events was surpris ingly low: five cases of suspected pulmonary embolism, confirmed by sc intigraphy in one case only, and one patient with phlebographically co nfirmed calf vein thrombosis. The use of reviparin for prevention of v enous thromboembolism was safe and convenient - the rate of post-opera tive bleeding complications was 2.3 % in the LMWH group, even lower th an in the control group (3.2 %). The real incidence of venous thromboe mbolism in patients undergoing laparoscopic cholecystectomy remains un clear. Further trials with unselected patients are needed.