Design of the Verbiest trial: cost-effectiveness of surgery versus prolonged conservative treatment in patients with lumbar stenosis

Background: Degenerative changes of lumbar spine anatomy resulting in the encroachment of neural structures are often regarded progressive, ultimately necessitating decompressive surgery. However the natural course is not necessarily progressive and the efficacy of a variety of nonsurgical interventions has also been described. At present there is insufficient data to compare surgical and nonsurgical interventions in terms of their relative benefit and safety. Previous attempts failed to provide clear clinical recommendations or to distinguish subgroups that substantially benefit from a certain treatment strategy. We present the design of a randomized controlled trial on (cost-) effectiveness of surgical decompression versus prolonged conservative treatment in patients with neurogenic intermittent claudication caused by lumbar stenosis. Methods/Design. The aim of the Verbiest trial is to evaluate the effectiveness of prolonged conservative treatment compared to decompressive surgery. The study is a multi-center randomized controlled trial with two parallel groups design. Patients (age over 50) presenting

Aspin: Neurosurgical Aspirin Intervention Prognostic Study; perioperative continuation versus discontinuation of aspirin in spinal surgery, a randomized controlled, noninferiority trial.

Abstract Rationale: Aspirin is typically discontinued in cranial and spinal surgery because of 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 &gt;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 haemorrhage in the surgical area with cauda and/or nerve root compression. - Post-surgical anaemia with haemoglobin-level lower than 5 mmol/l, requiring transfusion. - Subcutaneous haematoma leading to wound leakage and pain higher than NRS=7. - Major and/or minor haemorrhage 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 loos 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 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 and carries the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events. It is unclear if the possibility for an increase of hemorrhage related complications outweighs the risk of an increase of 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 of participating in this study. Outcome measurements are recorded during admission and regular outpatient visits, and thus, do not require additional visits to the hospital.</jats:p