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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01932255
Other study ID # 2013/883
Secondary ID
Status Withdrawn
Phase N/A
First received August 27, 2013
Last updated May 12, 2015
Start date October 2013
Est. completion date December 2014

Study information

Verified date May 2015
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Retrospective


Intervention

Procedure:
prophylactic spinal tap

no prophylactic spinal tap


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
St. Olavs Hospital Karolinska University Hospital, Norwegian University of Science and Technology, University Hospital of North Norway

Outcome

Type Measure Description Time frame Safety issue
Primary cerebrospinal fluid leakage Any leakage after 3rd postoperative day (since one hospital introduces iatrogenic leakage the first 3 days after surgery) 30 days No
Secondary overall complication risk 30 days No
Secondary Specific complication risk risks associated with prophylactic treatment: meningitis, positional head-ache (need for epidural blood-patch) 30 days No
Secondary days in hospital 30 days No
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