Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007931

Trial Description

start of 1:1-Block title

Title

Cranioplasty after 'decompressive' craniectomy
- Registry -

German Cranial Reconstruction Registry (GCRR)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

GCRR

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007931
  •   2015/06/08
  •   [---]*
  •   yes
  •   Approved
  •   S-529/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1168-7425 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   S06 -  Intracranial injury
  •   I62 -  Other nontraumatic intracranial haemorrhage
  •   I60 -  Subarachnoid haemorrhage
  •   I61 -  Intracerebral haemorrhage
  •   G08 -  Intracranial and intraspinal phlebitis and thrombophlebitis
  •   I67 -  Other cerebrovascular diseases
  •   osteolytic or bone-destructing tumours of the skull
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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. Patient specific risk factors, surgical details, materials for cranioplasty, intra- and postoperative complications as well as neurological outcome and cosmetic result will be recorded. The investigation period will cover acute complications as well as subsequent problems (e.g. aseptic bone necrosis) and long-term outcome.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/04/21
  •   1000
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Konsortium des GCRRStellvert. Prof. Dr. Oliver SakowitzKlinik für NeurochirurgieKlinikum Ludwigsburg
    • Posilipostraße 4
    • 71640  Ludwigsburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinikum Hamburg-EppendorfKlinik für Neurochirurgie
    • Mr.  Dr.  Thomas  Sauvigny 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Heidelberg
    • Mr.  Dr.  Henrik  Giese 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Heidelberg - Neurochirurgische Klinik
    • Mr.  Dr.  Henrik  Giese 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Codman DePuy SynthesMichalis NikolaouMarketing Manager - EMEACranial Surgery
    • 325 Paramount Drive
    • MA 02767  Raynham
    • United States
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.