CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
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|ClinicalTrials.gov Identifier: NCT01932255|
Recruitment Status : Withdrawn (inadequate data)
First Posted : August 30, 2013
Last Update Posted : May 13, 2015
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.
|Condition or disease||Intervention/treatment|
|Cranial Nerve Diseases Facial Neuralgia Trigeminal Neuralgia Hemifacial Spasm||Procedure: prophylactic spinal tap Procedure: no prophylactic spinal tap|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Observational Model:||Case Control|
|Official Title:||CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||December 2014|
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
- cerebrospinal fluid leakage [ Time Frame: 30 days ]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 ]
- Specific complication risk [ Time Frame: 30 days ]risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)
- days in hospital [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932255
|Study Chair:||Asgeir S Jakola, MD PhD||St. Olavs Hospital|