Clinical trial NCT03924700: Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial
Official title: Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Herniated Intervertebral Disc
Keywords: Herniated intervertebral disc
Discectomy
Microscope
Biportal endoscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 64
Sex: ALL
Minimum age (years): 20
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 discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine


Eligibility criteria: Inclusion Criteria:

* patients aged between 20 and 80
* patients who has radiating pain (VAS \>=40) on lower extremities with HIVD
* patients who required one-level discectomy 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)
* 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: at 1 year after surgery
Secondary outcomes:
measure: Change from baseline Oswestry disability index (ODI)
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: Change from baseline 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: Change from baseline EuroQoL-5 dimension (EQ-5D) value
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: Change from baseline PainDETECT score
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 time (minutes)
timeFrame: Immediate after operation
measure: Volume of postoperative drainage (ml)
timeFrame: Within 3 days after operation
measure: Number of participants with complete discectomy
timeFrame: Within 3 days after operation
measure: Concentration of creatine phosphokinase level in blood
timeFrame: At 2 day after surgery
measure: Volume of postoperative Fentanyl consumption
timeFrame: At 3 days after operation
measure: Times of hospital stay (hours)
timeFrame: Within 7 days after operation
measure: Number of radiographic complications
timeFrame: every year, up to 5 year after operation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggido
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
References: