Levin Häni1, Sonja Vulcu1, Mattia Branca2, Christian Fung3, Werner Josef Z'Graggen1,4, Michael Murek1, Andreas Raabe1, Jürgen Beck1,3, Philippe Schucht1. 1. 1Department of Neurosurgery, Inselspital, Bern University Hospital, University of Bern. 2. 2Clinical Trials Unit Bern, University of Bern, Switzerland. 3. 3Department of Neurosurgery, Medical Center-University of Freiburg, Germany; and. 4. 4Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland.
Abstract
OBJECTIVE: The use of subdural drains after surgical evacuation of chronic subdural hematoma (CSH) decreases the risk of recurrence and has become the standard of care. Halfway through the controlled, randomized TOSCAN (Randomized Trial of Follow-up CT after Evacuation of Chronic Subdural Hematoma) trial, the authors' institutional guidelines changed to recommend subgaleal instead of subdural drainage. The authors report a post hoc analysis on the influence of drain location in patients participating in the TOSCAN trial. METHODS: The study involved 361 patients enrolled in the TOSCAN trial. The patients were stratified according to whether they received surgery before (cohort A) or after (cohort B) the change in institutional protocol. An intention-to-treat analysis was performed with surgery for recurrence as the primary endpoint. Secondary endpoints were outcome-based on modified Rankin Scale scores, seizures, infections, parenchymal brain injuries, and hematoma diameter. RESULTS: Of the 361 patients included in the analysis, 214 were stratified into cohort A (subdural drainage recommended), while 147 were stratified into cohort B (subgaleal drainage recommended). There was a 31.78% rate of crossover from the subdural to the subgaleal drainage insertion site due to technical or anatomical difficulties. No differences in the rates of reoperation (21.5% [cohort A] vs 25.17% [cohort B], OR 0.81, 95% CI 0.50-1.34, p = 0.415), infections (0.47% [cohort A] vs 2.04% [cohort B], OR 0.23, 95% CI 0.02-2.19, p = 0.199), seizures (3.27% [cohort A] vs 2.72% [cohort B], OR 1.21, 95% CI 0.35-4.21, p = 0.765), or favorable outcomes (modified Rankin Scale score 0-3) at 1 and 6 months (91.26% [cohort A] vs 96.43% [cohort B], OR 0.39, 95% CI 0.14-1.07, p = 0.067; 89.90% [cohort A] vs 91.55% [cohort B], OR 0.82, 95% CI 0.39-1.73, p = 0.605) were noted between the two cohorts. Postoperatively, patients in cohort A had more frequent parenchymal brain tissue injuries (2.8% vs 0%, p = 0.041). Postoperative absolute and relative hematoma reduction was similar irrespective of the location of the drain. CONCLUSIONS: Subgaleal rather than subdural placement of the drain did not increase the risk for reoperation for recurrence of CSHs, nor did it have a negative impact on clinical or radiological outcome. The intention to place a subdural drain was associated with a higher rate of parenchymal injuries.
RCT Entities:
OBJECTIVE: The use of subdural drains after surgical evacuation of chronic subdural hematoma (CSH) decreases the risk of recurrence and has become the standard of care. Halfway through the controlled, randomized TOSCAN (Randomized Trial of Follow-up CT after Evacuation of Chronic Subdural Hematoma) trial, the authors' institutional guidelines changed to recommend subgaleal instead of subdural drainage. The authors report a post hoc analysis on the influence of drain location in patients participating in the TOSCAN trial. METHODS: The study involved 361 patients enrolled in the TOSCAN trial. The patients were stratified according to whether they received surgery before (cohort A) or after (cohort B) the change in institutional protocol. An intention-to-treat analysis was performed with surgery for recurrence as the primary endpoint. Secondary endpoints were outcome-based on modified Rankin Scale scores, seizures, infections, parenchymal brain injuries, and hematoma diameter. RESULTS: Of the 361 patients included in the analysis, 214 were stratified into cohort A (subdural drainage recommended), while 147 were stratified into cohort B (subgaleal drainage recommended). There was a 31.78% rate of crossover from the subdural to the subgaleal drainage insertion site due to technical or anatomical difficulties. No differences in the rates of reoperation (21.5% [cohort A] vs 25.17% [cohort B], OR 0.81, 95% CI 0.50-1.34, p = 0.415), infections (0.47% [cohort A] vs 2.04% [cohort B], OR 0.23, 95% CI 0.02-2.19, p = 0.199), seizures (3.27% [cohort A] vs 2.72% [cohort B], OR 1.21, 95% CI 0.35-4.21, p = 0.765), or favorable outcomes (modified Rankin Scale score 0-3) at 1 and 6 months (91.26% [cohort A] vs 96.43% [cohort B], OR 0.39, 95% CI 0.14-1.07, p = 0.067; 89.90% [cohort A] vs 91.55% [cohort B], OR 0.82, 95% CI 0.39-1.73, p = 0.605) were noted between the two cohorts. Postoperatively, patients in cohort A had more frequent parenchymal brain tissue injuries (2.8% vs 0%, p = 0.041). Postoperative absolute and relative hematoma reduction was similar irrespective of the location of the drain. CONCLUSIONS: Subgaleal rather than subdural placement of the drain did not increase the risk for reoperation for recurrence of CSHs, nor did it have a negative impact on clinical or radiological outcome. The intention to place a subdural drain was associated with a higher rate of parenchymal injuries.