Trial document





This trial has been registered retrospectively.
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  DRKS00006020

Trial Description

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Title

Retrospective analysis of clinical outcome and quality of life in patients undergoing surgical or conservative treatment of intracerebral cavernous malformations

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is designed to measure clinical outcome and quality of life in patients undergoing surgery for cerebral cavernous malformations. It is based on pre- and post-operative clinical and radiological findings. Equivalent data will be evaluated in patients with cerebral cavernous malformations undergoing conservative treatment. Data will be assessed by browsing patients charts and radiological imaging data using our database for cerebral cavernous malformations and will be completed by telephone interview.

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Brief Summary in Scientific Language

Cerebral cavernous malformations are vascular lesions of the capillary system characterized by recurrent intra- and extra-lesional hemorrhage. In 50% of the cases they become symptomatic with headache, neurological deficits or seizure depending on the anatomical location. The risk of hemorrhage is difficult to evaluate and is estimated with 1%/year. After initial hemorrhage the risk for consecutive hemorrhage is higher, with 30% during 2 years. Cerebral cavernous malformation occur as familial or sporadic disease. The therapy, including watch and wait, surgical resection or radiotherapy, of these lesions is discussed controversially. Up to date, no prospective randomized studies exist. However, with 0.5% of the population, these lesions have a relatively high incidence. Current treatment recommendations are based on smaller single center observational studies and few meta-analysis studying both postoperative outcome and natural history of the disease. Most studies, however, are fragmentary and lacking functional outcome and radiological outcome data. Quality of life was assessed in few small subgroups, only. In the neurosurgical department of the University Hospital of Essen a large number of patients with cerebral cavernous malformations have been treated (350 in 10 years), both surgically and conservatively, and followed up clinically and radiologically over a long period of time.
Aims of the study are a) longterm results (min. 2 years follow-up) after conservative or surgical treatment of cerebral cavernous malformations using functional outcome scales (Rankin Score, Glasgow outcome score, NIHSS score) and seizure outcome (ILAE), b) MRI follow up of complete/incomplete resection, respective future hemorrhage, c) evaluation of quality of life using telephone interview (SF36). Furthermore, all clinical and radiological data will be completed and categorized. Statistical correlation of categorical variables with outcome as described above will be performed and groups will be compared. Group assigning will be: surgical group and conservative group. Quality of life will additionally be compared to a healthy control cohort using matched-pair analysis. Superordinate aim is to weigh up outcome, treatment risks and risks of natural disease to incorporate in a prospective randomized controlled trial.

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Organizational Data

  •   DRKS00006020
  •   2015/08/18
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  •   yes
  •   Approved
  •   14-5751-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   D18.0 -  Haemangioma, any site
  •   G40.0 -  Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
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Interventions/Observational Groups

  •   Cerebral Cavernous Malformation
    Surgical Treatment
    Assessment of functional outcome (Rankin Score), Seizure outcome (ILAE score), quality of life (SF 36), CCM hemorrhage risk with MRI follow up
  •   Cerebral cavernous malformations
    conservative treatment
    Assessment of functional outcome (Rankin Score), Seizure outcome (ILAE score), quality of life (SF 36), CCM hemorrhage risk with MRI follow up
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Blinded
  •   assessor, data analyst
  •   No treatment
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Functional outcome at 1 year follow-up (Rankin score, Glasgow outcome score)
quality of life at 1 year follow-up (Short form 36)
seizure outcome at 1 year follow-up (International league against epilepsy score)

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Secondary Outcome

Functional outcome at max follow-up (Rankin score, Glasgow outcome score)
quality of life at max follow-up (Short form 36)
seizure outcome max follow-up (International league against epilepsy score)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/04/01
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Cerebral cavernous Malformation
Microsurgical Therapy
Pre Post Operative MRI
Complete Dataset

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Exclusion Criteria

Not willing to participate

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum EssenKlinik für Neurochirurgie
    • Mr.  Dr. med.  Philipp  Dammann 
    • Hufelandstrasse 44
    • 45127  Essen
    • Germany
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    • Universitätsklinikum EssenKlinik für Neurochirurgie
    • Mr.  Dr. med.  Philipp  Dammann 
    • Hufelandstrasse 44
    • 45127  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum EssenKlinik für Neurochirurgie
    • Hufelandstrasse 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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