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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01932255
Enrollment
0
Registered
2013-08-30
Start date
2013-10-31
Completion date
2014-12-31
Last updated
2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

microvascular decompression surgery, cerebrospinal fluid leakage, postoperative complications

Brief summary

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.

Interventions

PROCEDUREprophylactic spinal tap
PROCEDUREno prophylactic spinal tap

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
Karolinska University Hospital
CollaboratorOTHER
University Hospital of North Norway
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
cerebrospinal fluid leakage30 daysAny leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)

Secondary

MeasureTime frameDescription
overall complication risk30 days
Specific complication risk30 daysrisks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)
days in hospital30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026