Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial

Not Applicable

Completed

• Conditions: Degenerative Lumbar Spinal Stenosis

• Registration Number: NCT03302507
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-30
• Study First Posted: 2017-10-05
• Study Start: 2017-11-01
• Primary Completion: 2019-06-30
• Status Verified: 2019-10
• Study Completion: 2019-10-01
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oswestry disability index (ODI)	3, 6, and 12, months, and every year, up to 5 year after operation	The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.; This is assessed by ODI survey at 1 year after surgery

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 1 month after operation	Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
Postoperative drainage	Within 3 days after operation	Total drainage after surgery in milli-liter
Visual Analog Pain Scale (VAS)	4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation	VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.
EQ-5D	3, 6, and 12, months, and every year, up to 5 year after operation	EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
PainDETECT	3, 6, and 12, months, and every year, up to 5 year after operation	The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.
Completeness of decompression	Within 3 days after operation	After surgery, degree of decompression was measured using postoperative MRI
Creatine phosphokinase level in blood	At 2 day after surgery	Creatine phosphokinase assessment to measure muscle injury at operation
Postoperative Fentanyl consumption	At 3 days after operation	Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
Satisfaction scale	At 1 year after operation	Satisfaction scale is a short self-report questionnaire for evaluating patient satisfaction with the outcome of lumbar decompression surgery. Items are scored on a 7-point Likert scale with response categories consisting from very satisfied (7 points) to very dissatisfied (1 points).; Satisfaction after operation at 1 year after surgery
Amount of transfusion	Within 7 days after operation	Total transfusion during and after surgery in milli-liter
Hospital stay	Within 7 days after operation	Total hospital stay after surgery
Radiographic complications	every year, up to 5 year after operation,	Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture
Operation duration	Immediate after operation	Intraoperative time in minutes

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyounggido, Korea, Republic of