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. 2022 Aug;38(8):1461-1467.
doi: 10.1007/s00381-022-05540-5. Epub 2022 May 9.

Protocol for the multicentre prospective paediatric craniectomy and cranioplasty registry (pedCCR) under the auspices of the European Society for Paediatric Neurosurgery (ESPN)

Thomas Beez  1 , Martin U Schuhmann  2 , Paolo Frassanito  3 , Federico Di Rocco  4 , Ulrich W Thomale  5 , Hans Christoph Bock  6
Affiliations

Protocol for the multicentre prospective paediatric craniectomy and cranioplasty registry (pedCCR) under the auspices of the European Society for Paediatric Neurosurgery (ESPN)

Thomas Beez et al. Childs Nerv Syst. 2022 Aug.

Abstract

Purpose: In the paediatric age group, the overall degree of evidence regarding decompressive craniectomy (DC) and cranioplasty is low, whereas in adults, randomised controlled trials and prospective multicentre registries are available. To improve the evidence-based treatment of children, a consensus was reached to establish a prospective registry under the auspices of the European Society for Pediatric Neurosurgery (ESPN).

Methods: This international multicentre prospective registry is aimed at collecting information on the indication, timing, technique and outcome of DC and cranioplasty in children. The registry will enrol patients ≤ 16 years of age at the time of surgery, irrespective of the underlying medical condition. The study design comprises four obligatory entry points as a core dataset, with an unlimited number of further follow-up entry points to allow documentation until adolescence or adulthood. Study centres should commit to complete data entry and long-term follow-up.

Results: Data collection will be performed via a web-based portal (homepage: www.pedccr.com ) in a central anonymised database after local ethics board approval. An ESPN steering committee will monitor the project's progress, coordinate analyses of data and presentation of results at conferences and in publications on behalf of the study group.

Conclusion: The registry aims to define predictors for optimal medical care and patient-centred treatment outcomes. The ultimate goal of the registry is to generate results that are so relevant to be directly transferred into clinical practice to enhance treatment protocols.

Keywords: Allogeneic cranioplasty; Autologous cranioplasty; Bone flap resorption; Decompressive craniectomy; Functional outcome; Intracranial pressure.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Illustration of the study design, with 4 obligatory data entry points for a complete core data set
Fig. 2
Fig. 2
Representative screen shots of the pedCCR database — A homepage (homepage: www.pedccr.com) and B data entry form for DC
See this image and copyright information in PMC

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References

    1. Kolias AG, Adams H, Timofeev I, et al. Decompressive craniectomy following traumatic brain injury: developing the evidence base. Br J Neurosurg. 2016;30:246–250. doi: 10.3109/02688697.2016.1159655. - DOI - PMC - PubMed
    1. Hutchinson PJ, Kolias AG, Timofeev IS, et al. Trial of decompressive craniectomy for traumatic intracranial hypertension. N Engl J Med. 2016;375:1119–1130. doi: 10.1056/NEJMoa1605215. - DOI - PubMed
    1. Cooper DJ, Rosenfeld JV, Murray L, et al. Decompressive craniectomy in diffuse traumatic brain injury. N Engl J Med. 2011;364:1493–1502. doi: 10.1056/NEJMoa1102077. - DOI - PubMed
    1. Hofmeijer J, Kappelle LJ, Algra A, et al. Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurol. 2009;8:326–333. doi: 10.1016/S1474-4422(09)70047-X. - DOI - PubMed
    1. Vahedi K, Vicaut E, Mateo J, et al. Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial) Stroke. 2007;38:2506–2517. doi: 10.1161/STROKEAHA.107.485235. - DOI - PubMed