IntroductionChronic subdural haematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimise the risk of symptomatic recurrences. In the past, reoperation rates as high as 20%–30% were described for CSDH recurrences. However, following the introduction of subdural drainage, reoperation rates dropped to approximately 10%. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural drainage. Yet, the role of intraoperative irrigation has not been established. If there is no difference in recurrence rates between intraoperative irrigation and no irrigation, CSDH surgery could be carried out faster and more safely by omitting the step of irrigation. The aim of this multicentre randomised controlled trial is to study whether no intraoperative irrigation and subdural drainage results in non-inferior outcome compared with intraoperative irrigation and subdural drainage following burr-hole craniostomy of CSDH.Methods and analysisThis is a prospective, randomised, controlled, parallel group, non-inferiority multicentre trial comparing single burr-hole evacuation of CSDH with intraoperative irrigation and evacuation of CSDH without irrigation. In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6 months. The predefined non-inferiority margin for the primary outcome is 7.5%. To achieve a 2.5% level of significance and 80% power, we will randomise 270 patients per group. Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.Ethics and disseminationThe study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District (HUS/3035/2019 §238) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.Trial registration numberNCT04203550
Background A number of randomised controlled trials have shown the benefit of drain in operative treatment of chronic subdural haematomas (CSDHs). However, few reports describe real life result when adopting the drain placement into clinical practice. We report the results following a change in practice at Helsinki University Hospital from no drain to subdural drain (SD) placement after burr-hole craniostomies for CSDHs. Methods We conducted a retrospective observational study including consecutive patients undergoing burr-hole craniostomies for CSDHs. We compared outcomes between a sixmonth time period when the SD placement was arbitrary (July to December 2015) and a time period when SD placement for 48 h was routine (July to December 2017). Our primary outcome of interest was recurrences requiring reoperation within six months. Furthermore, patient outcome, infections and other complications were assessed. Results A total of 161 patients were included, of which 71 (44%) were in the SD group and 90 (56%) in the non-drain group. There were no differences in age, comorbidities, history of trauma or use of antithrombotic medication between the groups (p>0.05). Recurrences within six months occurred in 18% of patients in the non-drain group compared to 6% in the SD group (p=0.028; OR 0.28; 95% CI 0.09-0.87). There were no differences in neurological outcome (p=0.72), mortality rate (p=0.55), infection rate (p=0.96) or other complications (p=0.20). Conclusions The change in practice from no drain to SD after burr-hole craniostomies for CSDHs effectively reduced the six-month recurrence rate without any effect on patient outcome, infections or other complications.
OBJECTIVE The number of surgeries performed for chronic subdural hematoma (CSDH) has increased. However, these changes have been poorly reported. The authors aimed to assess the national incidence of surgeries for CSDH in Finland during an 18-year time period from 1997 to 2014. They hypothesized that the incidence of CSDH surgeries has continued to increase, particularly among the elderly. METHODS A nationwide register-based follow-up study was performed using the Finnish Care Register for Health Care. All adult patients undergoing primary CSDH surgeries during 1997–2014 were included. The study population was followed up from the time of CSDH surgery until death or the end of follow-up on December 31, 2017. The incidences of CSDH surgery per 100,000 person-years were calculated separately in each age group and sex. Age standardization was performed for those 20 years of age and older with weights from the 2013 European Standard Population. Negative binomial regression models were used to assess changes in incidence rate ratios (IRRs) during the study period. RESULTS In total, 9280 patients were identified. The age-standardized incidence of CSDH surgery increased from 12.2 to 16.5 per 100,000 person-years during 1997–2014. The age- and sex-adjusted incidence of CSDH surgery increased by 30% (IRR 1.30, 95% CI 1.20–1.41). The age- and sex-adjusted incidence increased more in the older age groups, with an IRR of 1.24 for those aged 60–69 years, 1.32 for those 70–79 years, 1.46 for those 80–89 years, and 1.85 for those aged 90 years or older. The adjusted incidence did not increase for those aged 18–59 years. The sex difference (2:1 men/women) was consistent throughout the study period, with a higher incidence among men. One year after the primary surgery, 19% of the population had a resurgery, and the 1-year case fatality rate was 15%. The median age of patients increased from 73 to 76 years. CONCLUSIONS During the past 2 decades, the age- and sex-adjusted incidence of CSDH surgery has increased in Finland, with major increases for those aged 60 years or older. This increase is likely to continue in parallel with the aging population and increased life expectancies.
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