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

Withdrawn

• Conditions: Cranial Nerve Diseases; Trigeminal Neuralgia; Hemifacial Spasm; Facial Neuralgia
• Interventions: Procedure: prophylactic spinal tap; Procedure: no prophylactic spinal tap

• Registration Number: NCT01932255
• Lead Sponsor: St. Olavs Hospital

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Study Start: 2013-10
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prophylactic spinal tap	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
no 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

Primary Outcome Measures

Name	Time	Method
cerebrospinal fluid leakage	30 days	Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)

Secondary Outcome Measures

Name	Time	Method
Specific complication risk	30 days	risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)
days in hospital	30 days
overall complication risk	30 days