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

Degenerative Lumbar Spinal Stenosis Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302507
• Other study ID #: BESS_001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 1, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• BESS
Biportal endoscopic surgery
• ULBD
Unilateral laminotomy bilateral decompression

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyounggido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry disability index (ODI)	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	3, 6, and 12, months, and every year, up to 5 year after operation
Secondary	Visual Analog Pain Scale (VAS)	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.	4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation
Secondary	EQ-5D	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.	3, 6, and 12, months, and every year, up to 5 year after operation
Secondary	PainDETECT	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.	3, 6, and 12, months, and every year, up to 5 year after operation
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)	up to 1 month after operation
Secondary	Operation duration	Intraoperative time in minutes	Immediate after operation
Secondary	Postoperative drainage	Total drainage after surgery in milli-liter	Within 3 days after operation
Secondary	Amount of transfusion	Total transfusion during and after surgery in milli-liter	Within 7 days after operation
Secondary	Completeness of decompression	After surgery, degree of decompression was measured using postoperative MRI	Within 3 days after operation
Secondary	Creatine phosphokinase level in blood	Creatine phosphokinase assessment to measure muscle injury at operation	At 2 day after surgery
Secondary	Postoperative Fentanyl consumption	Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)	At 3 days after operation
Secondary	Hospital stay	Total hospital stay after surgery	Within 7 days after operation
Secondary	Radiographic complications	Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture	every year, up to 5 year after operation,
Secondary	Satisfaction scale	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	At 1 year after operation