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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cranial Nerve Diseases; Facial Neuralgia; Trigeminal Neuralgia; Hemifacial Spasm
• Intervention / Treatment: Procedure: prophylactic spinal tap; Procedure: no prophylactic spinal tap

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: 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	Procedure: no prophylactic spinal tap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebrospinal fluid leakage	Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Karolinska University Hospital; University Hospital of North Norway; Norwegian University of Science and Technology
• Investigators: Study Chair: Asgeir S Jakola, MD PhD, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: postoperative complications; microvascular decompression surgery; cerebrospinal fluid leakage
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Neuromuscular Manifestations; Facial Nerve Diseases; Trigeminal Nerve Diseases; Spasm; Neuralgia; Nervous System Diseases; Facial Neuralgia; Trigeminal Neuralgia; Hemifacial Spasm; Cranial Nerve Diseases
• Other Study ID Numbers: 2013/883