CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
Even at centers with very large experience, the risk of cerebrospinal fluid (CSF) leakage in surgery for microvascular decompression is reported up to 3%.
Prevention of leakage is important since meningitis may follow. Also, leakage usually means longer hospital stay and increased cost.
In case of detected leakage extra sutures may be applied, placement of a lumbar drain may be considered or a revision and improved closure may be attempted. With leakage in the subcutaneous tissue, but not through the skin, a local accumulation causing local symptoms may also occur. In addition to being burdensome and being associated with longer hospital stays with possible revision surgery, such complications are also very costly. The best way to reduce cost and burden, and to improve patient care, is to prevent CSF leakage.
The aim of this study is to determine if prophylactic lumbar tap is beneficial for prevention of cerebrospinal fluid leakage following microvascular decompression, by comparison of surgical approaches in 3 geographical areas in the Scandinavian health system.
Hypothesis: There is no difference in cerebrospinal fluid leakage between the group subject to prophylactic spinal tap versus the group without prophylactic spinal tap.
Cranial Nerve Diseases
Procedure: prophylactic spinal tap
Procedure: no prophylactic spinal tap
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap|
- cerebrospinal fluid leakage [ Time Frame: 30 days ] [ Designated as safety issue: No ]Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)
- overall complication risk [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Specific complication risk [ Time Frame: 30 days ] [ Designated as safety issue: No ]risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)
- days in hospital [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
prophylactic spinal tap
Microvascular decompression surgery approach at the Karolinska University Hospital, i.e. a small craniectomy (removal of bone without putting it back), and postoperatively serial prophylactic lumbar tap
|Procedure: prophylactic spinal tap|
no prophylactic spinal tap
Microvascular decompression surgery approach at St Olavs Hospital Trondheim University Hospital and the University Hospital of North Norway, i.e. not comprising a policy of preventing CSF leak by performing prophylactic lumbar taps or its equivalents
|Procedure: no prophylactic spinal tap|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932255
|University Hospital of North Norway|
|St Olavs Hospital|
|Karolinska University Hospital|
|Study Chair:||Asgeir S Jakola, MD PhD||St. Olavs Hospital|