title: German Cranial Reconstruction Registry (GCRR): protocol for a prospective, multicentre, open registry.
abstract: BACKGROUND
  Owing to increasing numbers of decompressive craniectomies in patients with malignant middle cerebral artery infarction, cranioplastic surgery becomes more relevant. However, the current literature mainly consists of retrospective single-centre (evidence class III) studies. This leads to a wide variability of technical approaches and clinical outcomes. To improve our knowledge about the key elements of cranioplasty, which may help optimising clinical treatment and long-term outcome, a prospective multicentre registry across Germany, Austria and Switzerland will be established.
  
  
  METHODS
  All patients undergoing cranioplastic surgery in participating centres will be invited to join the registry. Technical methods, materials, medical history, adverse events and clinical outcome measures, including modified Rankin scale and EQ-5D, will be assessed at several time points. Patients will be accessible to inclusion either at initial decompressive surgery or when cranioplasty is planned. Scheduled monitoring will be carried out at time of inclusion and subsequently at time of discharge, if any readmission is necessary, and at follow-up presentation. Cosmetic results and patient satisfaction will also be assessed. Collected data will be managed and statistically analysed by an independent biometric institute. The primary endpoint will be mortality, need for operative revision and neurological status at 3 months following cranioplasty.
  
  
  BACKGROUND
  Ethics approval was obtained at all participating centres. The registry will provide reliable prospective evidence on surgical techniques, used materials, adverse events and functional outcome, to optimise patient treatment. We expect this study to give new insights in the treatment of skull defects and to provide a basis for future evidence-based therapy regarding cranioplastic surgery.
  
  
  BACKGROUND
  This trial is indexed in the German Clinical Trials Register (DRKS-ID: DRKS00007931). The Universal Trial Number (UTN) is U1111-1168-7425.
authors.affiliation: Department of Neurosurgery, University of Heidelberg, Heidelberg, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Giese
authors.affiliation: Department of Neurological Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Sauvigny
authors.affiliation: Department of Neurosurgery, Klinikum Ludwigsburg, University of Heidelberg, Ludwigsburg, Germany.
authors.forename: Oliver W
authors.initials: OW
authors.lastname: Sakowitz
authors.affiliation: Department of Neurosurgery, Trauma Center Murnau, Murnau, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Bierschneider
authors.affiliation: Department of Neurosurgery, University Hospital Bonn, Bonn, Germany.
authors.forename: Erdem
authors.initials: E
authors.lastname: Güresir
authors.affiliation: Department of Neurosurgery, University Hospital Rostock, Rostock, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Henker
authors.affiliation: Department of Neurosurgery, University Hospital Regensburg, Regensburg, Germany.
authors.forename: Julius
authors.initials: J
authors.lastname: Höhne
authors.affiliation: Department of Neurosurgery, University Hospital Leipzig, Leipzig, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Lindner
authors.affiliation: Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany.
authors.forename: Dorothee
authors.initials: D
authors.lastname: Mielke
authors.affiliation: Department of Neurosurgery, Heinrich-Heine-University, Düsseldorf, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Pannewitz
authors.affiliation: Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany.
authors.forename: Veit
authors.initials: V
authors.lastname: Rohde
authors.affiliation: Department of Neurosurgery, Duisburg Medical Center, Duisburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Scholz
authors.affiliation: Department of Neurosurgery, University Hospital Bonn, Bonn, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Schuss
authors.affiliation: Department of Neurological Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Regelsberger
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D003625:Data Collection / Q000379:methods*; D056424:Decompressive Craniectomy; D019317:Evidence-Based Medicine; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019651:Plastic Surgery Procedures; D012042:Registries; D012886:Skull / Q000601:surgery*
keywords: NEUROSURGERY