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
I. Baca et al., 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, Chirurg, 68(12), 1997, pp. 1275-1280
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.