German Clinical Trials Register

Acronym/abbreviation of the study

GCRR

URL of the study

No Entry

Brief summary in lay language

The planned registry contains systematically collected information and electronically stored data for diseases resulting in increased intracranial pressure (e.g. traumatic brain injury, intracranial haemorrhage) and bone-damaging tumours of the skull. In both diseases it is necessary to temporarily remove a part of the cranial bone. An operation is performed in the event of increased intracranial pressure to create additional space for the expansion of the brain. In the case of a bone-damaging tumour, the affected part of the bone is removed during tumour surgery. As a consequence, it is necessary to cover the defect to restore the integrity of the skull, to protect the brain and improve the ‘aesthetic’ shape of the head. The surgical coverage of the defect, which is called “cranioplasty”, may be performed either with the previously removed bone or with artificial material. Even though this type of operation is a standard neurosurgical procedure, it is performed very differently depending on the surgeon and the clinic. The purpose of the register is to collect information on the advantages and disadvantages of the different treatment methods. It will furthermore include additional data on the prognoses of diseases and correlating factors that affect the choice of surgery method, as well as the subsequent quality of life of the patient and eventual complications, and/or following diseases. Since appropriate studies on cranioplasties are not available at present, profound data collection is the overarching aim of the German Cranial Reconstruction Registry (GCRR). In doing so, this study endeavours to contribute to an enhanced and improved clinical treatment of affected patients.

Brief summary in scientific language

Objective: Cranioplasty plays a crucial role to restore the integrity of the skull, to protect the brain, to avoid disappointing cosmetic outcome and to prevent the sinking skin flap syndrome. Although cranioplasty is thought to be a standard neurosurgical procedure it is performed largely different depending on conventions in each neurosurgical unit. Wound healing disorders, intracranial bleedings, new neurological deficits and biological compatibility of the cranioplastic material are well known complications. While appropriate studies on cranioplasties are not available at present, profound data collection is the overarching principle of the GCRR to finally improve the clinical course of these patients. Methods: The GCRR is a project initiated by a consortium of individual members of the Section for Neurotrauma and Intensive Care in Neurosurgery of the Deutsche Gesellschaft für Neurochirurgie (DGNC). Every neurosurgical unit in Germany, Austria and Switzerland conducting cranioplasties is/will be invited to join the registry. This prospective multicenter database will focus on patients who received decompressive craniectomy and subsequent cranioplasty. A database will be set up in which each patient will be included anonymously. A substantial questionnaire has been developed and will be provided to all participating units. Patient specific risk factors, surgical details, materials for cranioplasty and intra- and postoperative complications will be recorded. The investigation period will cover acute complications as well as subsequent problems (e.g. aseptic bone necrosis) and long-term outcome. Data collection and submission will be performed locally. Central processing of anonymised questionnaires will be operated under the responsible surveillance of the consortium. The GCCR is a pure register study, therefore, there is no absolute end point of collection or a maximum group limitation. The study protocol provides an interim analysis after 2, 5 and 10 years. It is planned to include approximately 80 patients per year. Data-ownership or data interpretation will remain exclusively to the consortium and participating centers. All results of the GCRR including epidemiological data, surgical techniques, material for cranioplasty, complications, risk factors and long-term outcome will be published and/or reported at forthcoming conferences. Conclusion: Registry design and number of participating centers will secure a high quality of data which will allow to review our current clinical practice and to serve as a base for guidelines in cranioplastic surgery.