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

NCT01932255 | Withdrawn

• 1 other identifier: 2013/883
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cranial Nerve Diseases; Facial Neuralgia; Trigeminal Neuralgia; Hemifacial Spasm

Keywords

microvascular decompression surgery; cerebrospinal fluid leakage; postoperative complications

Outcome Measures

Primary Outcomes (1)

• cerebrospinal fluid leakage

  Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)

  30 days

Secondary Outcomes (3)

• overall complication risk

  30 days

• Specific complication risk

  30 days

• days in hospital

  30 days

Study Arms (2)

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

Interventions

prophylactic spinal tap PROCEDURE

prophylactic spinal tap

no prophylactic spinal tap PROCEDURE

no prophylactic spinal tap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Karolinska University Hospital: collaborator
• University Hospital of North Norway: collaborator

MeSH Terms

Conditions

Cranial Nerve Diseases; Facial Neuralgia; Trigeminal Neuralgia; Hemifacial Spasm; Cerebrospinal Fluid Leak; Postoperative Complications

Condition Hierarchy (Ancestors)

Nervous System Diseases; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Trigeminal Nerve Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes

Study Officials

• Asgeir S Jakola, MD PhD

  St. Olavs Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05