Bernard George1, Christian Matula2, Lars Kihlström3, Enrique Ferrer4, Vilhelm Tetens5. 1. Department of Neurosurgery, Hôpital Lariboisière, Paris, France. 2. Department of Neurosurgery, Medical University of Vienna, Vienna, Austria. 3. Department of Clinical Neuroscience, Karolinska University Hospital, Stockholm, Sweden. 4. Department of Neurosurgery, Hospital Clinic Barcelona, Barcelona, Spain. 5. Takeda Development Centre Europe, London, UK.
Abstract
BACKGROUND:Cerebrospinal fluid (CSF) leakage associated with incomplete sealing of the dura mater is a major complication of intradural procedures. OBJECTIVE: To compare the efficacy and safety of adjunctive TachoSil (Takeda Pharma A/S, Roskilde, Denmark) with current practice for the prevention of postoperative CSF leaks in patients undergoing elective skull base surgery involving dura mater closure. METHODS: Patients were intraoperatively randomized to TachoSil or current practice immediately before primary dura closure by suturing ± duraplasty. Choice of adjunctive treatment in the current practice group was at the surgeon's discretion. Primary efficacy endpoint was occurrence of clinically evident verified postoperative CSF leak or clinically evident pseudomeningocele within 7 weeks after surgery or treatment failure (third application of trial treatment or use of other treatment). RESULTS: A total of 726 patients were randomized to TachoSil (n = 361) or current practice (n = 365). More current practice patients had sutures plus duraplasty for primary dura closure compared with TachoSil (49.6% vs 35.7%) and fewer had sutures only (45.5% vs 63.2%). The primary endpoint of estimated leak rate favored TachoSil with events in 25 (6.9%) patients vs 30 (8.2%) current practice patients; however, this was not statistically significant (odds ratio: 0.82; 95% confidence interval: 0.47, 1.43; P = .485). Both treatments were well tolerated with similar frequency of adverse events. CONCLUSION: Very low rates of postoperative CSF leaks can be achieved in patients undergoing skull base surgery of various indications. Although the study did not meet its primary endpoint, TachoSil appears to be safe and effective for the prevention of CSF leaks and associated complications.
RCT Entities:
BACKGROUND: Cerebrospinal fluid (CSF) leakage associated with incomplete sealing of the dura mater is a major complication of intradural procedures. OBJECTIVE: To compare the efficacy and safety of adjunctive TachoSil (Takeda Pharma A/S, Roskilde, Denmark) with current practice for the prevention of postoperative CSF leaks in patients undergoing elective skull base surgery involving dura mater closure. METHODS:Patients were intraoperatively randomized to TachoSil or current practice immediately before primary dura closure by suturing ± duraplasty. Choice of adjunctive treatment in the current practice group was at the surgeon's discretion. Primary efficacy endpoint was occurrence of clinically evident verified postoperative CSF leak or clinically evident pseudomeningocele within 7 weeks after surgery or treatment failure (third application of trial treatment or use of other treatment). RESULTS: A total of 726 patients were randomized to TachoSil (n = 361) or current practice (n = 365). More current practice patients had sutures plus duraplasty for primary dura closure compared with TachoSil (49.6% vs 35.7%) and fewer had sutures only (45.5% vs 63.2%). The primary endpoint of estimated leak rate favored TachoSil with events in 25 (6.9%) patients vs 30 (8.2%) current practice patients; however, this was not statistically significant (odds ratio: 0.82; 95% confidence interval: 0.47, 1.43; P = .485). Both treatments were well tolerated with similar frequency of adverse events. CONCLUSION: Very low rates of postoperative CSF leaks can be achieved in patients undergoing skull base surgery of various indications. Although the study did not meet its primary endpoint, TachoSil appears to be safe and effective for the prevention of CSF leaks and associated complications.
Authors: Herbert Daniel Jiménez Zapata; Víctor Rodríguez Berrocal; Carlos Vior Fernández; Franklin Mariño Sánchez; Alfredo García Fernández Journal: J Neurol Surg B Skull Base Date: 2019-05-28
Authors: Ahmed Diab; Hieder Al-Shami; Ahmed Negida; Ahmed Gadallah; Hossam Farag; Doaa Mahmoud Elkadi; Mo'tasem Muhamed Gaber; Mahmoud Ahmed Ebada Journal: Surg Neurol Int Date: 2021-04-26
Authors: M Schindl; R Függer; P Götzinger; F Längle; M Zitt; S Stättner; P Kornprat; K Sahora; D Hlauschek; M Gnant Journal: Br J Surg Date: 2018-04-17 Impact factor: 6.939