Cranial Nerve DiseasesNCT01932255
CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
An observational study of Cranial Nerve Diseases and Facial Neuralgia, run by St. Olavs Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Nerve Diseases, Facial Neuralgia, Trigeminal Neuralgia
- What is being tested?
- prophylactic spinal tap and no prophylactic spinal tap
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- -
About this study
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.
Read more
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.
- Being tested
- prophylactic spinal tap, no prophylactic spinal tap
- Keywords
- microvascular decompression surgery, cerebrospinal fluid leakage, postoperative complications
- Medical subject headings
- Cranial Nerve Diseases, Facial Neuralgia, Trigeminal Neuralgia, Hemifacial Spasm, Cerebrospinal Fluid Leak, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic spinal tapProcedure or surgery
no prophylactic spinal tapProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: no prophylactic spinal tap |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebrospinal fluid leakage
Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)
Measured: 30 days
Secondary outcomes (3)
overall complication risk
Measured: 30 days
Specific complication risk
risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch)
Measured: 30 days
days in hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionDec 2014
Why it stopped: inadequate data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial Nerve DiseasesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Karolinska University Hospital, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Asgeir S Jakola, MD PhD, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932255
- Sponsor's protocol ID
- 2013/883
- Status last verified
- May 2015
- First submitted
- 27 Aug 2013
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
- ClinicalTrials.gov ID
- NCT01932255
- Acronym / sponsor ID
- 2013/883
- Keywords
- microvascular decompression surgery, cerebrospinal fluid leakage, postoperative complications
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: inadequate data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Karolinska University Hospital, University Hospital of North Norway
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prophylactic spinal tap | – | Procedure: prophylactic spinal tapMicrovascular 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 |
| no prophylactic spinal tap | – | Procedure: no prophylactic spinal tapMicrovascular 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prophylactic spinal tap | Procedure or surgery | prophylactic spinal tap |
| no prophylactic spinal tap | Procedure or surgery | no prophylactic spinal tap |
Primary outcome
cerebrospinal fluid leakage
Time frame: 30 days
Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery)
3 secondary outcomes
overall complication risk
Time frame: 30 days
Specific complication risk
Time frame: 30 days
days in hospital
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asgeir S Jakola, MD PhD study chair
St. Olavs Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cranial Nerve Diseases and Facial Neuralgia, run by St. Olavs Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebrospinal fluid leakage (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.