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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.
ISRCTN ISRCTN51857546
DOI 10.1186/ISRCTN51857546
ClinicalTrials.gov identifier
EudraCT number
Public title A multicenter double blind randomised clinical cost-effectiveness trial. Microendoscopic lumbar discectomy versus conventional microsurgery. Blind for patient and research-nurse.
Scientific title
Acronym Sciatica-MED-trial
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Multicenter randomised double-blind clinical cost-effectiveness trial
Countries of recruitment Netherlands
Disease/condition/study domain Sciatica
Participants - inclusion criteria 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.
Participants - exclusion criteria Does not match inclusion criteria
Anticipated start date 01/01/2006
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material
Target number of participants 150
Interventions Randomisation in operation room to:
1. Microendoscopic surgery
2. Conventional microsurgery
Primary outcome measure(s) Roland Disability Questionnaire for Sciatica (RDQ)
Secondary outcome measure(s) 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
Sources of funding Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (Netherlands)
Trial website
Publications 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
Contact name Dr  Wilco C  Peul
  Address Department of Neurosurgery LUMC
Leiden University Medical Center
Albinusdreef 2
  City/town Leiden
  Zip/Postcode 2333 ZA
  Country Netherlands
  Tel +31 (0)715262109
  Fax +31 (0)715248221
  Email w.c.peul@lumc.nl
Sponsor Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (Netherlands)
  Address Postbus 320
  City/town Diemen
  Zip/Postcode 1110AH
  Country Netherlands
  Tel +31 (0)207978555
  Fax +31 (0)207978500
  Email info@cvz.nl
Date applied 16/07/2004
Last edited 30/10/2012
Date ISRCTN assigned 08/09/2004
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