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ISRCTN
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ISRCTN51857546
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DOI
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10.1186/ISRCTN51857546
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A multicenter double blind randomised clinical cost-effectiveness trial. Microendoscopic lumbar discectomy versus conventional microsurgery. Blind for patient and research-nurse.
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Scientific title
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Acronym
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Sciatica-MED-trial
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Serial number at source
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N/A
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Study hypothesis
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Severe sciatica caused by a lumbar disc herniation with root compression and indication for surgery based on clinical picture and Magnetic Resonance Imaging (MRI).
Microendoscopic discectomy (MED) is more (cost)-effective than open discectomy.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Multicenter randomised double-blind clinical cost-effectiveness trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Sciatica
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Participants - inclusion criteria
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Patients (18-70 years) with at least 8 weeks sciatica not reacting to conservative treatment. An indication for surgery is made by the clinical picture with MRI confirmation of a lumbar disc herniation.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/01/2006
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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Randomisation in operation room to:
1. Microendoscopic surgery
2. Conventional microsurgery
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Primary outcome measure(s)
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Roland Disability Questionnaire for Sciatica (RDQ)
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Secondary outcome measure(s)
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1. Perceived recovery
2. Visual anolog scale (VAS)
3. VAS of back pain and combined leg and back pain
4. McGill pain questionnaire
5. Short-Form-36 questionnaire (SF 36)
6. Sciatica frequency and bothersome index (SFBI)
7. Prolo scale
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Sources of funding
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Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (Netherlands)
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Trial website
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Publications
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1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16696861
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19584344
3. 2010 subgroup analysis in http://www.ncbi.nlm.nih.gov/pubmed/20547620
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21623248
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Contact name
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Dr
Wilco C
Peul
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Address
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Department of Neurosurgery LUMC
Leiden University Medical Center
Albinusdreef 2
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City/town
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Leiden
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Zip/Postcode
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2333 ZA
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Country
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Netherlands
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Tel
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+31 (0)715262109
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Fax
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+31 (0)715248221
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Email
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w.c.peul@lumc.nl
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Sponsor
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Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (Netherlands)
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Address
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Postbus 320
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City/town
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Diemen
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Zip/Postcode
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1110AH
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Country
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Netherlands
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Tel
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+31 (0)207978555
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Fax
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+31 (0)207978500
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Email
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info@cvz.nl
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Date applied
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16/07/2004
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Last edited
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30/10/2012
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Date ISRCTN assigned
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08/09/2004
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