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Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial.

ABSTRACT: 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 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 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.

SUBMITTER: Tommiska P

PROVIDER: S-EPMC7311024 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial.

Tommiska Pihla P Raj Rahul R Schwartz Christoph C Kivisaari Riku R Luostarinen T T Satopää Jarno J Taimela Simo S Järvinen Teppo T Ranstam Jonas J Frantzen Janek J Posti Jussi J Luoto Teemu M TM Leinonen Ville V Tetri Sami S Koivisto Timo T Lönnrot Kimmo K

BMJ open 20200621 6

<h4>Introduction</h4>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 ...[more]

PMID: 32565480

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Project description:BackgroundChronic subdural haematoma (CSDH) is one of the most common types of intracranial haematoma, and often occurs in older people. Burr-hole craniostomy, which is an evacuation through one or two burr holes drilled over the site of the haematoma, has been widely accepted as the most effective way to manage CSDH. Recurrences are a major problem and need reoperation, sometimes repeatedly.ObjectivesTo assess the effects and safety of the use of external drains versus no drains after burr-hole evacuation for the treatment of CSDH in adults.Search methodsWe ran our first search on 27 November 2014. We searched the Cochrane Injuries Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE (OvidSP), Embase Classic+Embase (OvidSP), PubMed, ISI WOS (SCI-EXPANDED, SSCI, CPCI-S and CPSI-SSH), Chinese databases, and clinical trials registers, and screened reference lists. In compliance with the MECIR conduct standard 37, the Cochrane Injuries Group Information Specialist ran an update search within 12 months of publication (25 April 2016). We have screened these results but not incorporated the findings into the current review; as a result of the update search, one trial is awaiting classification.Selection criteriaWe included randomized controlled trials (RCTs) that compared external subdural drains with no drains after burr-hole evacuation for the treatment of CSDH in adults.Data collection and analysisTwo review authors identified potential articles from the literature search, extracted data independently using a data extraction form and assessed risk of bias using the Cochrane 'Risk of bias' tool. For dichotomous data, where statistical heterogeneity was low, we calculated summary risk ratios with 95% confidence intervals using a fixed-effect model.Main resultsNine RCTs, including a total of 968 participants, reported outcomes specified by this review. Only one RCT reported the use of an adequate method of allocation concealment; this trial was a large, single-centre, high quality study and was adequately reported. All included trials reported a reduced recurrence of CSDH with external subdural drains. We found a significant reduction in the risk of recurrence with subdural drains (RR 0.45, 95% CI 0.32 to 0.61, I(2) = 38%; 9 studies, 968 participants; moderate-quality evidence). There was no strong evidence of any increase in complications (RR 1.15; 95% CI 0.77 to 1.72, I(2) = 0%; 7 studies, 710 participants; low-quality evidence), mortality (RR 0.78, 95% CI 0.45 to 1.33, I(2) = 22%; 5 studies, 539 participants; low-quality evidence), or poor functional outcome (which included deaths) (RR 0.68, 95% CI 0.44 to 1.05, I(2) = 31%; 5 studies, 490 participants; low-quality evidence).Authors' conclusionsThere is some evidence that postoperative drainage is effective in reducing the symptomatic recurrence of CSDH. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Due to the low quality of the evidence for the secondary outcomes, the effect of drainage on the occurrence of surgical complications, mortality and poor functional outcome is uncertain. This uncertainty can be clarified with data from high-quality studies which may be conducted in the future. There is no strong evidence of any increase in complications when drains are used.

Project description:BackgroundChronic subdural haematoma (CSDH) is becoming increasingly prevalent, due to an aging population with increasing risk factors. Due to its variable disease course and high morbidity, patient centred care and shared decision making are essential. However, its occurrence in frail populations, remote from specialist neurosurgeons who currently triage treatment decisions, challenges this. Education is an important component of enabling shared decisions. This should be targeted to avoid information overload. However, it is unknown what this should be.ObjectivesOur objectives were to conduct analysis of the content of existing CSDH educational materials, to inform the development of patient and relative educational resources to facilitate shared decision making.MethodsA literature search was conducted (July 2021) of MEDLINE, Embase and grey literature, for all self-specified resources on CSDH education, and narrative reviews. Resources were classified into a hierarchical framework using inductive thematic analysis into 8 core domains: Aetiology, epidemiology and pathophysiology; natural history and risk factors; symptoms; diagnosis; surgical management; nonsurgical management; complications and recurrence; and outcomes. Domain provision was summarised using descriptive statistics and Chi-squared tests.Results56 information resources were identified. 30 (54%) were resources designed for healthcare professionals (HCPs), and 26 (46%) were patient-orientated resources. 45 (80%) were specific to CSDH, 11 (20%) covered head injury, and 10 (18%) referenced both acute and chronic SDH. Of 8 core domains, the most reported were aetiology, epidemiology and pathophysiology (80%, n = 45) and surgical management (77%, n = 43). Patient orientated resources were more likely to provide information on symptoms (73% vs 13%, p<0.001); and diagnosis (62% vs 10%, p<0.001) when compared to HCP resources. Healthcare professional orientated resources were more likely to provide information on nonsurgical management (63% vs 35%, p = 0.032), and complications/recurrence (83% vs 42%, p = 0.001).ConclusionThe content of educational resources is varied, even amongst those intended for the same audience. These discrepancies indicate an uncertain educational need, that will need to be resolved in order to better support effective shared decision making. The taxonomy created can inform future qualitative studies.

Dataset Information

Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial.

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Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial.

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