Clinical trial NCT03302507: Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial
Official title: Outcomes Following Bilateral Decompression Surgery in Lumbar Spinal Stenosis With Biportal Endoscopy Versus Unilateral Laminotomy Technique: A Prospective, Single-blinded, Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Lumbar Spinal Stenosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis


Eligibility criteria: Inclusion Criteria:

* patients aged between 30 and 80
* patients who has radiating pain (VAS \>=40) on lower extremities with spinal stenosis over Gr B
* patients who required one-level decompression between L1 and S1
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion Criteria:

* Revision surgery
* Over spondylolisthesis Gr II
* Degenerative lumbar scoliosis (Cobb angle \>20)
* herniated disc
* patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
* women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
* patients with mental retardation or whose parents or legal guardians were older or had mental disabilities
* other patients viewed as inappropriate by the staff

Primary outcomes:
measure: Oswestry disability index (ODI)
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
Secondary outcomes:
measure: Visual Analog Pain Scale (VAS)
timeFrame: 4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation
measure: EQ-5D
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: PainDETECT
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 1 month after operation
measure: Operation duration
timeFrame: Immediate after operation
measure: Postoperative drainage
timeFrame: Within 3 days after operation
measure: Amount of transfusion
timeFrame: Within 7 days after operation
measure: Completeness of decompression
timeFrame: Within 3 days after operation
measure: Creatine phosphokinase level in blood
timeFrame: At 2 day after surgery
measure: Postoperative Fentanyl consumption
timeFrame: At 3 days after operation
measure: Hospital stay
timeFrame: Within 7 days after operation
measure: Radiographic complications
timeFrame: every year, up to 5 year after operation,
measure: Satisfaction scale
timeFrame: At 1 year after operation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggido
Study officials:
References: