Trial document




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  DRKS00004842

Trial Description

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Title

Minimally invasive resection of spinal and paraspinal benign nerve sheath tumors

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Minimally invasive surgical techniques are used in increasing numbers in various surgical fields. This also applies to spinal surgery.
Benign processes of the spine include nerve sheath tumors such as schwannomas and neurofibromas. The traditional surgical treatment involves microsurgical removal via open approaches. Recently, several minimally invasive techniques have been described. These minimally invasive techniques have been used regularly for the treatment of spinal tumors in the Department of Neurosurgery University Hospital Freiburg since 2007.
This research project is to characterize the role of minimally invasive surgical techniques for the removal of benign nerve sheath tumors.

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Brief Summary in Scientific Language

Minimally invasive surgical techniques are used in increasing numbers in various surgical fields. This also applies to spinal surgery.
Benign processes of the spine include nerve sheath tumors such as schwannomas and neurofibromas. The traditional surgical treatment involves microsurgical removal via open approaches. Recently, several minimally invasive techniques have been described. These minimally invasive techniques have been used regularly for the treatment of spinal tumors in the Department of Neurosurgery University Hospital Freiburg since 2007.
This research project is to characterize the role of minimally invasive surgical techniques for the removal of benign nerve sheath tumors.

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Organizational Data

  •   DRKS00004842
  •   2013/08/19
  •   [---]*
  •   yes
  •   Approved
  •   98/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   D36.1 -  Benign neoplasm: Peripheral nerves and autonomic nervous system
  •   D48.2 -  Neoplasm of uncertain or unknown behaviour: Peripheral nerves and autonomic nervous system
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Interventions/Observational Groups

  •   Minimally invasive resection of spinal and paraspinal benign nerve sheath tumors.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Completeness of tumor resection (postoperative MRI)

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Secondary Outcome

Postoperative neurological status compared to preoperative; estimated blood loss; operative time

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/03
  •   13
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Operative resection of a spinal/paraspinal tumor via a minimal-invasive approach between 06/2007 and 10/2012. Verification of a schwannoma or neurofibroma.

Amendment 02/17 with extended period of retrospective inclusion (06/2007 - 10/2016).

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Exclusion Criteria

Verification of a malignant nerve sheath tumor.

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Addresses

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    • Neurochirurgische Universitätsklinik Freiburg
    • Mr. 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Neurochirurgische Universitätsklinik Freiburg
    • Mr.  Dr. med.  Jan-Helge  Klingler 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Neurochirurgische Universitätsklinik Freiburg
    • Mr.  Dr. med.  Jan-Helge  Klingler 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Neurochirurgische Universitätsklinik Freiburg
    • Mr.  Dr. med.  Jan-Helge  Klingler 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/09/21
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.