Publikation: Zeitschriftenartikel

German Cranial Reconstruction Registry (GCRR)

Grunddaten
Abstract
Autoren
Einrichtung

Grunddaten

Titel	German Cranial Reconstruction Registry (GCRR)
Untertitel	protocol for a prospective, multicentre, open registry
Veröffentlicht in	BMJ open. - London : BMJ Publishing Group
Erscheinungsjahr	2015
Seiten (von – bis)	1 – 5
Band	5
Heft-Nr.	9
Jahr	2015
Publikationsform	Elektronische Ressource
Publikationsart	Zeitschriftenartikel
Sprache	Englisch
DOI	10.1136/bmjopen-2015-009273
Letzte Änderung	11.08.2021 06:01:48
Bearbeitungsstatus	durch UB Rostock abschließend validiert
Dauerhafte URL	http://purl.uni-rostock.de/fodb/pub/49727
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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. - Trial registration number This trial is indexed in the German Clinical Trials Register (DRKS-ID: DRKS00007931). The Universal Trial Number (UTN) is U1111-1168-7425.

Autoren

Giese, Henrik
Sauvigny, Thomas
Sakowitz, Oliver
Henker, Christian

Einrichtung

UMR/Klinik und Poliklinik für Chirurgie (CUK)