Clinical trial NCT01932255: CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
Official title: CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cranial Nerve Diseases
Facial Neuralgia
Trigeminal Neuralgia
Hemifacial Spasm
Keywords: microvascular decompression surgery
cerebrospinal fluid leakage
postoperative complications
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Karolinska University Hospital
name: University Hospital of North Norway
First posted: 2013-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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:

-

Primary outcomes:
measure: cerebrospinal fluid leakage
timeFrame: 30 days
Secondary outcomes:
measure: overall complication risk
timeFrame: 30 days
measure: Specific complication risk
timeFrame: 30 days
measure: days in hospital
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: St. Olavs Hospital
name: Asgeir S Jakola, MD PhD
role: STUDY_CHAIR
References: