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

S

St. Olavs Hospital

Status

Withdrawn

Conditions

Facial Neuralgia
Trigeminal Neuralgia
Cranial Nerve Diseases
Hemifacial Spasm

Treatments

Procedure: prophylactic spinal tap
Procedure: no prophylactic spinal tap

Study type

Observational

Funder types

Other

Identifiers

NCT01932255
2013/883

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

prophylactic spinal tap
Description:
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
Treatment:
Procedure: prophylactic spinal tap
no prophylactic spinal tap
Description:
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
Treatment:
Procedure: no prophylactic spinal tap

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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