A multicenter double blind randomised clinical cost-effectiveness trial. Microendoscopic lumbar discectomy versus conventional microsurgery. Blind for patient and research-nurse.

ISRCTN	ISRCTN51857546
DOI	https://doi.org/10.1186/ISRCTN51857546
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Wilco C Peul
Scientific

Department of Neurosurgery
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Phone	+31 (0)715262109
Email	w.c.peul@lumc.nl

Study design	Multicenter randomised double-blind clinical cost-effectiveness trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A multicenter double blind randomised clinical cost-effectiveness trial. Microendoscopic lumbar discectomy versus conventional microsurgery. Blind for patient and research-nurse.
Study acronym	Sciatica-MED-trial
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Sciatica
Intervention	Randomisation in operation room to: 1. Microendoscopic surgery 2. Conventional microsurgery
Intervention type	Procedure/Surgery
Primary outcome measure	Roland Disability Questionnaire for Sciatica (RDQ)
Secondary outcome measures	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
Overall study start date	01/01/2006
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Both
Target number of participants	150
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2008

Leiden University Medical Center

Leiden
2333 ZA
Netherlands

Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (Netherlands)
Government

Postbus 320
Diemen
1110AH
Netherlands

Phone	+31 (0)207978555
Email	info@cvz.nl

Government

College voor Zorgverzekeringen
Government organisation / National government

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	13/05/2006	Yes	No
Results article	results	08/07/2009	Yes	No
Other publications	subgroup analysis	01/11/2010	Yes	No
Results article	results	01/10/2011	Yes	No
Results article	long-term results	01/12/2017	Yes	No

30/05/2017: Publication reference added.