BACKGROUND: The Sonopet(®) ultrasonic bone aspirator (Stryker(®) , Kalamazoo, MI) has been used within neurosurgery, otolaryngology and in other fields, but to our knowledge has not been reported in the literature for use in endoscopic transsphenoidal approaches (TSAs) to the skull base. The study objective was to compare use of the ultrasonic bone aspirator (UBA) vs traditional cold steel instrumentation during TSA in terms of operative time and blood loss. METHODS: The study design was a prospective, randomized, single-blinded controlled clinical trial. The population included patients who presented to a tertiary care skull base center with pituitary tumors amenable to endoscopic resection. Participants were randomized to either an endoscopic approach using the ultrasonic bone aspirator (n = 66) or traditional steel instrumentation (n = 64). Outcomes measured were operative time and blood loss for the approach and exposure portion of the procedure. RESULTS: The use of the UBA resulted in a significant reduction in both operative time (31.92 ± 3.04 minutes vs 41.32 ± 2.75 minutes, p < 0.0001) and blood loss (16.5 ± 5.37 milliliters vs 22.57 ± 3.09 milliliters, p < 0.0001) compared to traditional steel instrumentation. CONCLUSION: This study is, to our knowledge, the first prospective, randomized, controlled clinical trial comparatively demonstrating the speed, safety and efficacy of the ultrasonic bone aspirator for endoscopic TSA to the skull base. Although the UBA offers surgical benefits, the cost of disposables may limit its usefulness to use in tertiary care institutions where operative cost can be shared across departments and with the hospital.
RCT Entities:
BACKGROUND: The Sonopet(®) ultrasonic bone aspirator (Stryker(®) , Kalamazoo, MI) has been used within neurosurgery, otolaryngology and in other fields, but to our knowledge has not been reported in the literature for use in endoscopic transsphenoidal approaches (TSAs) to the skull base. The study objective was to compare use of the ultrasonic bone aspirator (UBA) vs traditional cold steel instrumentation during TSA in terms of operative time and blood loss. METHODS: The study design was a prospective, randomized, single-blinded controlled clinical trial. The population included patients who presented to a tertiary care skull base center with pituitary tumors amenable to endoscopic resection. Participants were randomized to either an endoscopic approach using the ultrasonic bone aspirator (n = 66) or traditional steel instrumentation (n = 64). Outcomes measured were operative time and blood loss for the approach and exposure portion of the procedure. RESULTS: The use of the UBA resulted in a significant reduction in both operative time (31.92 ± 3.04 minutes vs 41.32 ± 2.75 minutes, p < 0.0001) and blood loss (16.5 ± 5.37 milliliters vs 22.57 ± 3.09 milliliters, p < 0.0001) compared to traditional steel instrumentation. CONCLUSION: This study is, to our knowledge, the first prospective, randomized, controlled clinical trial comparatively demonstrating the speed, safety and efficacy of the ultrasonic bone aspirator for endoscopic TSA to the skull base. Although the UBA offers surgical benefits, the cost of disposables may limit its usefulness to use in tertiary care institutions where operative cost can be shared across departments and with the hospital.
Authors: Taylor Anne Wilson; Lei Huang; Dinesh Ramanathan; Miguel Lopez-Gonzalez; Promod Pillai; Kenneth De Los Reyes; Muhammad Kumal; Warren Boling Journal: Front Oncol Date: 2020-11-20 Impact factor: 6.244