CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap

Study Overview
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Brief Summary
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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.

Official Title
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CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap

Conditions
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Cranial Nerve Diseases, Facial Neuralgia, Trigeminal Neuralgia, Hemifacial Spasm

Intervention / Treatment
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* Procedure: prophylactic spinal tap
* Procedure: no prophylactic spinal tap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: microvascular decompression surgery for neurovascular conflict (hemifacial spasm, trigeminal neuralgia) surgery between 1990 and 2013 Follow-up visit registered in medical charts > 30 days postoperatively (at either local hospital, treating neurologist or at neurosurgical clinic) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prophylactic spinal tap<br>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<br> <br> |
| no prophylactic spinal tap<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebrospinal fluid leakage | Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall complication risk |  | 30 days | 
| Specific complication risk | risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch) | 30 days | 
| days in hospital |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microvascular decompression surgery, cerebrospinal fluid leakage, postoperative complications