METHODS/DESIGN: Patients (age 18-70 years) presenting with
sciatica due to lumbar
disc herniation lasting more than 6-8 weeks are included. Patients with
disc herniation larger than 1/3 of the spinal canal diameter, or
disc herniation less than 1/3 of the spinal canal diameter with concomitant lateral recess
stenosis or sequestration, are eliglible for participation. Randomisation into microendoscopic
discectomy or conventional unilateral transflaval
discectomy will take place in the operating room after induction of
anesthesia. The length of skin incision is equal in both groups. The primary outcome measure is the functional assessment of the patient, measured by the Roland Disability Questionnaire for
Sciatica, at 8 weeks and 1 year after surgery. We will also evaluate several other outcome parameters, including perceived recovery, leg and
back pain, incidence of re-operations, complications, serum
creatine kinase, quality of life, medical consumption, absenteeism and costs. The study is a randomised prospective multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 2 years.
DISCUSSION: Currently, open
discectomy is the golden standard in the surgical treatment of lumbar
disc herniation. Whether microendoscopic
discectomy is more cost-effective than unilateral transflaval
discectomy has to be determined by this trial.