An observational study in Cranial Nerve Diseases, Facial Neuralgia and Trigeminal Neuralgia, sponsored by St. Olavs Hospital. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-13.
Sponsored by St. Olavs Hospital · Observational
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.
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
Browse Trigeminal Neuralgia studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
Compared within Trigeminal Neuralgia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Facial Neuralgia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Exclusion Criteria:
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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
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
cerebrospinal fluid leakage
Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)
Time frame: 30 days
overall complication risk
Time frame: 30 days
Specific complication risk
risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)
Time frame: 30 days
days in hospital
Time frame: 30 days
No study locations are listed for this record.
This study is withdrawn, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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