Giese, Henrik and Sauvigny, Thomas and Sakowitz, Oliver W. and Bierschneider, Michael and Gueresir, Erdem and Henker, Christian and Hoehne, Julius and Lindner, Dirk and Mielke, Dorothee and Pannewitz, Robert and Rohde, Veit and Scholz, Martin and Schuss, Patrick and Regelsberger, Jan (2015) German Cranial Reconstruction Registry (GCRR): protocol for a prospective, multicentre, open registry. BMJ OPEN, 5 (9): e009273. ISSN 2044-6055,
Full text not available from this repository. (Request a copy)Abstract
Introduction: 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. Ethics and dissemination: 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | MIDDLE-CEREBRAL-ARTERY; TRAUMATIC BRAIN-INJURY; KINGDOM SHUNT REGISTRY; EDEMA TRIAL HAMLET; DECOMPRESSIVE CRANIECTOMY; MALIGNANT INFARCTION; HEMISPHERIC INFARCTION; TERRITORY INFARCTION; CLINICAL ARTICLE; HEMICRANIECTOMY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurochirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 26 Jul 2019 10:45 |
| Last Modified: | 26 Jul 2019 10:45 |
| URI: | https://pred.uni-regensburg.de/id/eprint/6178 |
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