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
Martin N Stienen,
Kevin Akeret,
Flavio Vasella,
Julia Velz,
Elisabeth Jehli,
Pierre Scheffler,
Stefanos Voglis,
Oliver Bichsel,
Nicolas Roydon Smoll,
Oliver Bozinov,
Luca Regli,
Menno R Germans,
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
Affiliations
Martin N Stienen
Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
Kevin Akeret
Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
Flavio Vasella
Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
Julia Velz
8 Clinical Neuroscience Center and Department of Neurosurgery, University Hospital and University of Zurich, Zurich, Switzerland
Elisabeth Jehli
Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
Pierre Scheffler
Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
Stefanos Voglis
Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland
Oliver Bichsel
Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
Nicolas Roydon Smoll
School of Population and Global Health, University of Melbourne, Melbourne, Sydney, Australia
Oliver Bozinov
Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland
Luca Regli
4Clinical Neuroscience Center and Department of Neurosurgery, University Hospital Zürich, University of Zürich, Zürich, Switzerland
Menno R Germans
Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland
David Bellut
Sandra F. Dias
Giuseppe Esposito
3 Department of Radiology, Georgetown University, Washington, District of Columbia, USA
Jorn Fierstra
Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland
Dilek Könü-Leblebicioglu
Niklaus Krayenbühl
Marian C. Neidert
Markus Oertel
Carlo Serra
Lennart H. Stieglitz
Lazar Tosic
Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland
Laurenz Peltenburg-Brechneff
Basil E. Grüter
Anna-Sophie Hofer
Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland
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.
