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1.
Trials ; 25(1): 156, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38424535

RESUMO

RATIONALE: Aspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events. OBJECTIVE: The aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing low complex lumbar spinal surgery, compared with the current policy of perioperative discontinuation of aspirin. STUDY DESIGN: A randomized controlled trial with two parallel groups of 277 cases (554 in total). STUDY POPULATION: Patients undergoing low complex lumbar spinal surgery and using aspirin. All patients are aged >18 years. INTERVENTION: Peri-operative continuation of aspirin. STUDY OUTCOMES: Primary study outcome: composite of the following bleeding complications: Neurological deterioration as a result of hemorrhage in the surgical area with cauda and/or nerve root compression. Post-surgical anemia with hemoglobin level lower than 5 mmol/l, requiring transfusion. Subcutaneous hematoma leading to wound leakage and pain higher than NRS=7. Major and/or minor hemorrhage in any other body system according to the definition of the International Society on Thrombosis and Haemostasis bleeding scale. Secondary study outcomes: Each of the individual components of the primary outcome Absolute mean difference in operative blood loss between the study arms Thrombo-embolic-related complications: Myocardial infarction Venous thromboembolism Stroke Arterial thromboembolism FURTHER STUDY OUTCOMES: Anticoagulant treatment satisfaction by the Anti-Clot Treatment Scale (ACTS) and general health by the Patient-Reported Outcomes Measurement Information System (PROMIS Global-10) in the pre- and postoperative phase. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study imposes no additional risk to patients. Currently, there is no consensus on whether or not aspirin should be discontinued before cranial or spinal surgery. Currently, aspirin is typically discontinued in cranial and spinal surgery, because of a potential increased risk of hemorrhagic complication. An argument not based on a clinical trial. However, this policy might delay surgical procedures or carry the risk of resulting in an increase in cardiac and neurologic thrombotic perioperative events. It is unclear if the possibility of an increase in hemorrhage-related complications outweighs the risk of an increase in cardiac and neurologic thrombotic perioperative events. Furthermore, the Data Safety Monitoring Board (DSMB) will be asked for safety analysis by monitoring the study. There are no further disadvantages to participating in this study. Outcome measurements are recorded during admission and regular outpatient visits, and thus, do not require additional visits to the hospital.


Assuntos
Aspirina , Trombose , Humanos , Anticoagulantes/uso terapêutico , Aspirina/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Neurocirúrgicos , Inibidores da Agregação Plaquetária/efeitos adversos , Prognóstico , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Front Surg ; 9: 988565, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36632524

RESUMO

Background: A spinal epidural abscess (SEA) of the cervical spine is a relatively rare disease and is generally characterized by progressive neurological deterioration due to compression of the spinal cord. Up to 40% of cervical SEAs are located ventrally of the spinal cord. Urgent surgical intervention is warranted to decompress the spinal cord and collect material for cultures to guide antibiotic treatment. However, the optimal timing of the intervention is unclear, and the associated risk of spinal instability in the presence of an extensive infection is a significant clinical dilemma. Methods: In this paper, we present a novel surgical technique to treat a cervical SEA by anterior decompression through a linear transvertebral midline approach. This technique has the advantage of effectively draining the ventrally located SEA and obtaining material for bacteria culture while maintaining spinal stability without additional instrumentation. Results: This case study presents seven patients with cervical SEAs who were successfully treated with surgical decompression by this transvertebral linear midline technique and antibiotic treatment. Conclusion: Anterior decompression through a linear transvertebral midline approach for a ventrally located cervical SEA is a safe and pragmatic surgical procedure to achieve spinal cord decompression and collect bacteria culture without destabilizing the cervical spine.

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