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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

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

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.


Detailed Summary:
Sponsor: St. Olavs Hospital

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: St. Olavs Hospital

Dates:
Date Received: August 27, 2013
Date Started: October 2013
Date Completion:
Last Updated: May 12, 2015
Last Verified: May 2015