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Clinical Trial
Journal Article
Randomized Controlled Trial
Low-molecular-weight heparin versus saphenofemoral disconnection for the treatment of above-knee greater saphenous thrombophlebitis: a prospective study.
The objective of this study was to assess the efficacy, safety, and cost of low-molecular-weight heparin compared to saphenofemoral disconnection for the treatment of internal saphenous proximal thrombophlebitis (SPT). Eighty-four consecutive patients diagnosed as presenting SPT alone (symptoms/echo-Doppler) were divided into 2 comparable groups treated with (1) saphenofemoral disconnection under local anesthesia with a short hospital stay (n = 45) or (2) prospective enoxaparin on an outpatient basis for 4 weeks (n = 39). Informed consent was obtained and inclusion, exclusion, and withdrawal criteria were established. Patients were followed up at 1, 3, and 6 months. Thirty patients per group completed the study requirements. In the disconnection group, 2 patients (6.7%) presented complications of the surgical wound, 1 (3.3%) had SPT recurrence (however, there was no deep venous thrombosis), and 2 (6.7%) had nonfatal pulmonary embolism confirmed by radionuclide scan. In the enoxaparin group, there were 2 cases (6.7%) of minor bleeding (epistaxis and rectal bleeding) and 3 (10%) recurrences of SPT. In the enoxaparin group there was no case of progression of the thrombosis to the deep venous system or pulmonary embolism. The study found no statistically significant differences between saphenofemoral disconnection and enoxaparin in the treatment of SPT, but the low-molecular-weight heparin group had socioeconomic advantages.
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