Oral rivaroxaban for postoperative prophylaxis of venous thromboembolism after sleeve gastrectomy in patients with morbid obesity, is it safe: A prospective randomized clinical trial
Mahmoud A. Eissa, Tamer M. Elmahdy, S. Elgarf, A. Swelam, Gamal Mousa, Amr S. Ghobara, S. Saber
{"title":"Oral rivaroxaban for postoperative prophylaxis of venous thromboembolism after sleeve gastrectomy in patients with morbid obesity, is it safe: A prospective randomized clinical trial","authors":"Mahmoud A. Eissa, Tamer M. Elmahdy, S. Elgarf, A. Swelam, Gamal Mousa, Amr S. Ghobara, S. Saber","doi":"10.21608/ejsur.2024.279555.1034","DOIUrl":null,"url":null,"abstract":"Background: Deep vein thrombosis and pulmonary embolism are still one of the most crucial problems after weight-reducing surgeries in patients suffering from obesity. Many techniques were documented and routinely applied to prevent venous thromboembolism (VTE), particularly in those who are at high risk as morbid obese patients (BMI >40 kg/m 2 ), geriatric patients, and those who had previous history of VTE and open or revisional surgery. Patients and Methods: We conducted this randomized prospective clinical trial during the period from January 2021 to January 2023 on 500 obese patients who underwent sleeve gastrectomy for weight reduction divided into two groups: In the 250 patients of group A we used postoperative low-molecular-weight heparins (LMWH) 40 mg once daily subcutaneous injection for VTE prophylaxis, while group B (250 patients) were given oral anticoagulants (rivaroxaban) on the other hand. Results: This study aimed to compare the results of using both drugs as regards complications including both VTE and bleeding. Regarding bleeding, it also can present with a wide range of manifestations ranging from mild symptoms like port site hematoma, perigastric hematoma, or hematemesis, and melena. Regarding the age of patients in the studied groups there was no statistically significant difference between both groups. The incidence of minor, moderate to major, and life-threatening bleeding was nearly the same between both groups with no statistically significant difference. Throughout the study, only one case of porto-mesenteric thrombosis in the LMWH group. No clinically suspected Lower Limb deep vein thrombosis throughout the study with no need to do lower limb venous duplex. Conclusion: The safety and efficacy of Rivaroxaban as one of the most commonly used new Oral anticoagulants resembles that of the LMWH as a prophylaxis of VTE following weight-reducing sleeve gastrectomy surgery and could be a good oral alternative for LMWH.","PeriodicalId":22550,"journal":{"name":"The Egyptian Journal of Surgery","volume":"58 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Egyptian Journal of Surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21608/ejsur.2024.279555.1034","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Deep vein thrombosis and pulmonary embolism are still one of the most crucial problems after weight-reducing surgeries in patients suffering from obesity. Many techniques were documented and routinely applied to prevent venous thromboembolism (VTE), particularly in those who are at high risk as morbid obese patients (BMI >40 kg/m 2 ), geriatric patients, and those who had previous history of VTE and open or revisional surgery. Patients and Methods: We conducted this randomized prospective clinical trial during the period from January 2021 to January 2023 on 500 obese patients who underwent sleeve gastrectomy for weight reduction divided into two groups: In the 250 patients of group A we used postoperative low-molecular-weight heparins (LMWH) 40 mg once daily subcutaneous injection for VTE prophylaxis, while group B (250 patients) were given oral anticoagulants (rivaroxaban) on the other hand. Results: This study aimed to compare the results of using both drugs as regards complications including both VTE and bleeding. Regarding bleeding, it also can present with a wide range of manifestations ranging from mild symptoms like port site hematoma, perigastric hematoma, or hematemesis, and melena. Regarding the age of patients in the studied groups there was no statistically significant difference between both groups. The incidence of minor, moderate to major, and life-threatening bleeding was nearly the same between both groups with no statistically significant difference. Throughout the study, only one case of porto-mesenteric thrombosis in the LMWH group. No clinically suspected Lower Limb deep vein thrombosis throughout the study with no need to do lower limb venous duplex. Conclusion: The safety and efficacy of Rivaroxaban as one of the most commonly used new Oral anticoagulants resembles that of the LMWH as a prophylaxis of VTE following weight-reducing sleeve gastrectomy surgery and could be a good oral alternative for LMWH.