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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Recruitment Status : Withdrawn (inadequate data)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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cranial Nerve Diseases Facial Neuralgia Trigeminal Neuralgia Hemifacial Spasm Procedure: prophylactic spinal tap Procedure: no prophylactic spinal tap

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
Study Start Date : October 2013
Primary Completion Date : July 2014
Study Completion Date : December 2014

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. overall complication risk [ Time Frame: 30 days ]
  2. Specific complication risk [ Time Frame: 30 days ]
    risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)

  3. days in hospital [ Time Frame: 30 days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The planned study is a retrospective review of medical charts in consecutive patients undergoing surgery for neurovascular conflict by microvascular decompression surgery. Patients will be identified from the operating protocols at the respective hospitals.

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:

Contacts and Locations

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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

Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Karolinska University Hospital
University Hospital of North Norway
Study Chair: Asgeir S Jakola, MD PhD St. Olavs Hospital
More Information

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01932255     History of Changes
Other Study ID Numbers: 2013/883
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by St. Olavs Hospital:
microvascular decompression surgery
cerebrospinal fluid leakage
postoperative complications

Additional relevant MeSH terms:
Trigeminal Neuralgia
Hemifacial Spasm
Nervous System Diseases
Facial Neuralgia
Cranial Nerve Diseases
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Neuromuscular Manifestations