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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Karolinska University Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01932255
First received: August 27, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention
Cranial Nerve Diseases
Facial Neuralgia
Trigeminal Neuralgia
Hemifacial Spasm
Procedure: prophylactic spinal tap
Procedure: no prophylactic spinal tap

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • cerebrospinal fluid leakage [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)


Secondary Outcome Measures:
  • overall complication risk [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Specific complication risk [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)

  • days in hospital [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932255

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

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01932255     History of Changes
Other Study ID Numbers: 2013/883
Study First Received: August 27, 2013
Last Updated: July 25, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on July 28, 2014