Minimally invasive resection of spinal and paraspinal benign nerve sheath tumors
Organizational Data
- DRKS-ID:
- DRKS00004842
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2013-08-19
- Last update in DRKS:
- 2024-04-10
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Minimally invasive surgical techniques are increasingly being used in a wide variety of surgical fields. This also applies to spinal surgery. Benign nerve sheath tumors in the area of the spine include so-called schwannomas and neurofibromas. Conventional surgical treatment involves removal via conventional open approaches. In recent years, data have been published describing minimally invasive techniques using smaller approaches with specialized access instruments. These minimally invasive techniques have been regularly used at the Department of Neurosurgery at the University of Freiburg for the treatment of benign nerve sheath tumors since 2007. The present research project aims to characterize the value of minimally invasive surgical techniques for the removal of benign nerve sheath tumors.
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.
Health condition or problem studied
- ICD10:
- D36.1 - Peripheral nerves and autonomic nervous system
- ICD10:
- D48.2 - Peripheral nerves and autonomic nervous system
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Evaluation of the efficacy and safety of minimally invasive resection of spinal and paraspinal benign nerve sheath tumors.
Endpoints
- Primary outcome:
- Completeness of tumor resection (postoperative MRI)
- Secondary outcome:
- Postoperative neurological status compared to preoperative; estimated blood loss; operative time
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Neurochirurgische Klinik Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2013-08-21
- Actual study start date:
- 2014-02-03
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-05-06
- Target Sample Size:
- 13
- Final Sample Size:
- 49
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- 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). Amendment 06/20 with extended period of retrospective inclusion (06/2007 - 12/2019).
Exclusion Criteria
Verification of a malignant nerve sheath tumor.
Addresses
Primary Sponsor
- Address:
- Neurochirurgische Universitätsklinik FreiburgBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Neurochirurgische Universitätsklinik FreiburgDr. med. Jan-Helge KlinglerBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
Contact for Public Queries
- Address:
- Neurochirurgische Universitätsklinik FreiburgDr. med. Jan-Helge KlinglerBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
Principal Investigator
- Address:
- Neurochirurgische Universitätsklinik FreiburgDr. med. Jan-Helge KlinglerBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Neurochirurgische Universitätsklinik FreiburgBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-02-28
- Ethics committee number:
- 98/13
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-03-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry