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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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| Author: | Tommiska, Pihla1; Raj, Rahul1; Schwartz, Christoph1,2; |
| Organizations: |
1Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland 2Department of Neurosurgery, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria 3Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland
4Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland
5Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland 6Clinical Sciences, Lunds Universitet, Lund, Sweden 7Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland 8Department of Neurosurgery, Tampere University Hospital and Tampere University, Tampere, Finland 9Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland 10Unit of Clinical Neuroscience, Neurosurgery, University of Oulu and Medical Research Center, Oulu, Finland |
| Format: | article |
| Version: | published version |
| Access: | open |
| Online Access: | PDF Full Text (PDF, 0.4 MB) |
| Persistent link: | http://urn.fi/urn:nbn:fi-fe2020120399229 |
| Language: | English |
| Published: |
BMJ,
2020
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| Publish Date: | 2020-12-03 |
| Description: |
AbstractIntroduction: 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 see all
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| Series: |
BMJ open |
| ISSN: | 2044-6055 |
| ISSN-E: | 2044-6055 |
| ISSN-L: | 2044-6055 |
| Volume: | 10 |
| Issue: | 6 |
| Article number: | e038275 |
| DOI: | 10.1136/bmjopen-2020-038275 |
| OADOI: | https://oadoi.org/10.1136/bmjopen-2020-038275 |
| Type of Publication: |
A1 Journal article – refereed |
| Field of Science: |
3126 Surgery, anesthesiology, intensive care, radiology 3124 Neurology and psychiatry |
| Subjects: | |
| Funding: |
This study was supported by the State funding for university-level health research (Helsinki University Hospitals), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv & Hälsa. |
| Copyright information: |
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
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https://creativecommons.org/licenses/by-nc/4.0/ |