Browsing by Subject "CLOSED-SYSTEM DRAINAGE"

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  • Tommiska, Pihla; Raj, Rahul; Schwartz, Christoph; Kivisaari, Riku; Luostarinen, T.; Satopää, Jarno; Taimela, Simo; Järvinen, Teppo; Ranstam, Jonas; Frantzen, Janek; Posti, Jussi; Luoto, Teemu M.; Leinonen, Ville; Tetri, Sami; Koivisto, Timo; Lönnrot, Kimmo (2020)
    Introduction Chronic 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 analysis This 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 48hours as a standard of treatment. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6months. 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 dissemination The 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 number NCT04203550
  • Tommiska, Pihla; Lonnrot, Kimmo; Raj, Rahul; Luostarinen, Teemu; Kivisaari, Riku (2019)
    BACKGROUND: A number of randomized controlled trials have shown the benefit of drain placement in the operative treatment of chronic subdural hematoma (CSDH); however, few reports have described real-life results after adoption of 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 craniostomy for CSDH. METHODS: We conducted a retrospective observational study of consecutive patients undergoing burr hole craniostomy for CSDH. We compared outcomes between a 6-month period when SD placement was arbitrary (Julye December 2015) and a period when SD placement for 48 hours was routine (July-December 2017). Our primary outcome of interest was recurrence of CSDH necessitating reoperation within 6 months. Patient outcomes, infections, and other complications were assessed as well. RESULTS: A total of 161 patients were included, comprising 71 (44%) in the drain group and 90 (56%) in the non-drain group. There were no significant differences in age, comorbidities, history of trauma, or use of antithrombotic agents between the 2 groups (P > 0.05 for all). Recurrence within 6 months occurred in 18% of patients in the non-drain group, compared with 6% in the drain group (odds ratio, 0.28; 95% confidence interval, 0.09-0.87; P = 0.028). There were no differences in neurologic outcomes (P = 0.72), mortality (P = 0.55), infection rate (P = 0.96), or other complications (P = 0.20). CONCLUSIONS: The change in practice from no drain to use of an SD after burr hole craniostomy for CSDH effectively reduced the 6-month recurrence rate with no effect on patient outcomes, infections, or other complications.