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

Status Withdrawn

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.

Clinical Trial Description

n/a

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

• NCT number: NCT01932255
• Study type: Observational
• Source: St. Olavs Hospital
• Status: Withdrawn
• Phase: N/A
• Start date: October 2013
• Completion date: December 2014