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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01932255
• Other study ID #: 2013/883
• Status: Withdrawn
• Phase: N/A
• First received: August 27, 2013
• Last updated: May 12, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cranial Nerve Diseases
• Facial Neuralgia
• Hemifacial Spasm
• Nervous System Diseases
• Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• prophylactic spinal tap

• no prophylactic spinal tap

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Karolinska University Hospital, Norwegian University of Science and Technology, University Hospital of North Norway

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebrospinal fluid leakage	Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)	30 days	No
Secondary	overall complication risk		30 days	No
Secondary	Specific complication risk	risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)	30 days	No
Secondary	days in hospital		30 days	No