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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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Surgery
Protocol
Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial
  1. Pihla Tommiska1,
  2. Rahul Raj1,
  3. Christoph Schwartz1,2,
  4. Riku Kivisaari1,
  5. T Luostarinen3,
  6. Jarno Satopää1,
  7. Simo Taimela4,5,
  8. Teppo Järvinen4,5,
  9. Jonas Ranstam6,
  10. Janek Frantzen7,
  11. Jussi Posti7,
  12. Teemu M Luoto8,
  13. Ville Leinonen9,
  14. Sami Tetri10,
  15. Timo Koivisto9,
  16. Kimmo Lönnrot1
  1. 1Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland
  2. 2Department of Neurosurgery, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria
  3. 3Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland
  4. 4Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland
  5. 5Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland
  6. 6Clinical Sciences, Lunds Universitet, Lund, Sweden
  7. 7Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland
  8. 8Department of Neurosurgery, Tampere University Hospital and Tampere University, Tampere, Finland
  9. 9Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland
  10. 10Unit of Clinical Neuroscience, Neurosurgery, University of Oulu and Medical Research Center, Oulu, Finland
  1. Correspondence to Dr Rahul Raj; rahul.raj{at}helsinki.fi

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

  • chronic subdural haematoma
  • surgical evacuation
  • recurrence
  • irrigation fluid
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-038275

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    Footnotes

    • Twitter @rahulbrraj, @jonasranstam

    • PT and RR contributed equally.

    • Contributors KL, RR, CS, RK, JS, TML, TJ and ST designed the trial. PT, RR, CS, TML, JS, ST, TJ, JF, JR, JP, TML, VL, ST, TK and KL have been involved in drafting the manuscript or revising it critically for important intellectual content. All authors read and approved the final manuscript.

    • Funding This study was supported by the State funding for university-level health research (Helsinki University Hospitals), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv & Hälsa.

    • Disclaimer The funding source will have no role in the collection, analysis and interpretation of data; in the writing of the report and in the decision to submit the article for publication.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.