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

Primary Purpose

Degenerative Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BESS
ULBD
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BESS, biportal endoscopic spine surgery

ULBD, unilateral laminotomy bilateral decompression

Arm Description

Biportal endoscopic decompression surgery for lumbar spinal stenosis

Minimally invasive ULBD for lumbar spinal stenosis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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)
Operation duration
Intraoperative time in minutes
Postoperative drainage
Total drainage after surgery in milli-liter
Amount of transfusion
Total transfusion during and after surgery in milli-liter
Completeness of decompression
After surgery, degree of decompression was measured using postoperative MRI
Creatine phosphokinase level in blood
Creatine phosphokinase assessment to measure muscle injury at operation
Postoperative Fentanyl consumption
Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)
Hospital stay
Total hospital stay after surgery
Radiographic complications
Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture
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

Full Information

First Posted
September 21, 2017
Last Updated
October 10, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03302507
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyounggido
Country
Korea, Republic of

12. IPD Sharing Statement

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

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