CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
NCT ID: NCT01932255
Last Updated: 2015-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
2013-10-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
NCT01867268
Perioperative CSF Leak Management - an Opinion Study
NCT04124523
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage
NCT06472505
Bed Rest on the Effect of CSF Leakage Repair After Transsphenoidal Pituitary Surgery
NCT05682391
The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
NCT04917380
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
no prophylactic spinal tap
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
prophylactic spinal tap
no prophylactic spinal tap
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Norwegian University of Science and Technology
OTHER
Karolinska University Hospital
OTHER
University Hospital of North Norway
OTHER
St. Olavs Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Asgeir S Jakola, MD PhD
Role: STUDY_CHAIR
St. Olavs Hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013/883
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.