osteolytic or bone-destructing tumours of the skull I63 S06 I62 I60 I61 G08 I67
Conditions
Interventions
Group 1: The GCCR is a single-arm observational study. All patients with a "decompressive" or “tumor related” craniectomy and subsequent cranioplasty are analyzed using a structured questionnaire. Pat
Sponsors
Konsortium des GCRRStellvert. Prof. Dr. Oliver SakowitzKlinik für NeurochirurgieKlinikum Ludwigsburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with a clinical condition that requires temporary removal of the cranial bone (decompressive craniectomy, DC) • Space-occupying cerebral infarction • Traumatic Brain Injury • Subarachnoid haemorrhage • Intracranial haemorrhage • Sinus venous thrombosis • Space-occupying cerebral infections 2. Patients after DC which now require surgical cranioplasty (CP) 3. Patients with osteolytic or bone-destructing tumours of the skull 4. Age of (legal) majority
Exclusion criteria
Exclusion criteria: 1. Patients in a clinical condition that requires permanent removal of the cranial bone 2. Patients in palliative care 3. Patients with craniofacial malformations (e.g. craniosynostosis) 4. Patients that require skull base reconstruction 5. Patients after suboccipital DC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Neurological status (GOS, mRs) before and after 1st and 2nd surgery and at time of re-presentation 2) Overall mortality: death within a period of 3 months ± 14 d after cranioplasty intervention 3) Surgical revision within a period of 3 months ± 14 d after cranioplasty intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Patient satisfaction after cranioplasty surgery 2) Time to bone flap re-implantation (cranioplasty) 3.) Rate of surgery-related complications of both procedures (craniectomy and cranioplasty) detected up to 30 days after surgery 4) Quality indicators of surgery | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactHenrik Giese
Universitätsklinikum Heidelberg - Neurochirurgische Klinik
Outcome results
None listed