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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
NCT02927782 |
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Date of registration:
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06/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mobilisation Algorithm After Incidental Durotomy
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Scientific title:
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Flat Bed Rest vs. Immediate Mobilisation After Incidental Durotomy During Lumbar Spinal Surgery: A Prospective Randomised Trial |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02927782 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Mazda Farshad, MD MPH |
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Address:
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Telephone:
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+413861274 |
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Email:
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mazda.farshad@balgrist.ch |
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Affiliation:
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Name:
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Mazda Farshad, MD MPH |
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Address:
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Telephone:
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+413861274 |
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Email:
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mazda.farshad@balgrist.ch |
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Affiliation:
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Name:
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Mazda Farshad, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Balgrist Zurich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
All patients over the age of 18 years with an ID sustained during a primary or revision
lumbar spinal procedure at our institution are the subject of this prospective, randomised
analysis.
Exclusion Criteria:
Patients referred for repair of an externally sustained ID, cases in which durotomy was
not primarily recognised and repaired as well as patient who refuse to sign informed
consent are going to be excluded from this analysis. Informed consent is going to be
obtained one day prior to index procedure.
Further Intervention because of Spondylitis/Spondylodiscitis, Tumor, Trauma. Pregnant
patients
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebrospinal Fluid Leak
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Intervention(s)
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Procedure: Bed Rest
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Procedure: Early Mobilization
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Primary Outcome(s)
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Reoperation rate
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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