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  • COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial

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Neurology
Protocol
COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial
  1. Martin N Stienen1,
  2. Kevin Akeret1,
  3. Flavio Vasella1,
  4. Julia Velz1,
  5. Elisabeth Jehli1,
  6. Pierre Scheffler1,
  7. Stefanos Voglis1,
  8. Oliver Bichsel1,
  9. Nicolas Roydon Smoll2,
  10. Oliver Bozinov1,
  11. Luca Regli1,
  12. Menno R Germans1
  13. on behalf of the CORRECT-SCAR study group*
    1. 1Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
    2. 2School of Population and Global Health, University of Melbourne, Melbourne, Sydney, Australia
    1. Correspondence to Dr Martin N Stienen; mnstienen{at}gmail.com

    Abstract

    Introduction Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH). However, the surgery leads to bony defects in the skull with skin depressions above that are frequently considered aesthetically unsatisfactory by the patients. Those defects could be covered by the approved medical devices (burr hole covers), but this is rarely done today. We wish to assess, whether the application of burr hole covers after trepanation for the evacuation of cSDH leads to higher patient satisfaction with the aesthetical result at 90 days postoperative, without worsening disability outcomes or increasing the complication rate.

    Methods and analysis This is a prospective, single-blinded, randomised, controlled, investigator-initiated clinical trial enrolling 80 adult patients with first-time unilateral or bilateral cSDH in Switzerland. The primary outcome is the difference in satisfaction with the aesthetic result of the scar, comparing patients allocated to the intervention (burr hole cover) and control (no burr hole cover) group, measured on the Aesthetic Numeric Analogue scale at 90 days postoperative. Secondary outcomes include differences in the rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative.

    Ethics and dissemination The institutional review board (Kantonale Ethikkommission Zürich) approved this study on 29 January 2019 under case number BASEC 2018–01180. This study determines, whether a relatively minor modification of a standard surgical procedure can improve patient satisfaction, without worsening functional outcomes or increasing the complication rate. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years.

    Trial registration number NCT03755349.

    • Burr hole cover
    • Chronic subdural hematoma
    • Trepanation
    • Aestheticoutcome
    • Complications
    • Scar
    • Patientsatisfaction
    • Burr hole plate

    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-2019-031375

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      Footnotes

      • Collaborators *Contributors of the “CORRECT-SCAR study group” (persons listed in alphabetical order): Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland: David Bellut, Sandra F. Dias, Giuseppe Esposito, Jorn Fierstra, Dilek Könü-Leblebicioglu, Niklaus Krayenbühl, Marian C. Neidert, Markus Oertel, Carlo Serra, Lennart H. Stieglitz, Lazar Tosic, Laurenz Peltenburg-Brechneff, Basil E. Grüter, Anna-Sophie Hofer, Alexander Küffer, Philip-Rudolf Rauch, Martina Sebök, Bas van Niftrik, Tristan P. C. van Doormaal.

      • Contributors Those persons listed as authors on the manuscript have made substantial contributions to the conception or design of the work, are currently involved in acquiring, analysing or interpreting the data for the work. They all have been active in drafting or revising the study protocol for important intellectual content, which is basis of the current article. All authors have approved the final version to be published. They agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. In detail: MNS, KA, FV, JV, EJ, PS, SV, OB, NRS, OB, LR and MRG designed the study, are local (principal) investigators or other key persons. MNS acquired the funding. MNS reviewed the literature and drafted the manuscript. KA, FV, JV, EJ, PS, SV, OB, NRS, OB, LR and MRG contributed to drafting of the manuscript. All authors read and approved the final manuscript.

      • Funding This research is financed and conducted by the Department of Neurosurgery, University Hospital Zurich, Switzerland. It is financially supported by the Stryker company, after careful and independent review of the study protocol.

      • Competing interests None declared.

      • Patient consent for publication Not required.

      • Ethics approval The study protocol has been approved by the local IRB (Kantonale Ethikkommission Zürich) on 29 January 2019 (BASEC 2018–01180). Protocol modifications have to be approved by the local IRB and communicated to trial registries.

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