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

NCT01932255 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-05-13

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

prophylactic spinal tap

PROCEDURE

no prophylactic spinal tap

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Asgeir S Jakola, MD PhD · St. Olavs Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-07-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01932255 on ClinicalTrials.gov