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
Protocol serial number	N/A
Sponsor	Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (Netherlands)
Funder	College voor Zorgverzekeringen

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

Primary study design	Interventional
Study design	Multicenter randomised double-blind clinical cost-effectiveness trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Roland Disability Questionnaire for Sciatica (RDQ)
Key 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
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/07/2009		Yes	No
Results article	results	01/10/2011		Yes	No
Results article	long-term results	01/12/2017		Yes	No
Protocol article	protocol	13/05/2006		Yes	No
Other publications	subgroup analysis	01/11/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

30/05/2017: Publication reference added.