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Completed

NCT Number: NCT03302507

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

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

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Key information

Conditions

Degenerative Lumbar Spinal Stenosis

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BESS

Procedure

Biportal endoscopic surgery

ULBD

Procedure

Unilateral laminotomy bilateral decompression

Primary outcomes

  1. Oswestry disability index (ODI)

    Time frame: 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 outcomes

  1. Visual Analog Pain Scale (VAS)

    Time frame: 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.

  2. EQ-5D

    Time frame: 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.

  3. PainDETECT

    Time frame: 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.

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: up to 1 month after operation

    Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)

  5. Operation duration

    Time frame: Immediate after operation

    Intraoperative time in minutes

  6. Postoperative drainage

    Time frame: Within 3 days after operation

    Total drainage after surgery in milli-liter

  7. Amount of transfusion

    Time frame: Within 7 days after operation

    Total transfusion during and after surgery in milli-liter

  8. Completeness of decompression

    Time frame: Within 3 days after operation

    After surgery, degree of decompression was measured using postoperative MRI

  9. Creatine phosphokinase level in blood

    Time frame: At 2 day after surgery

    Creatine phosphokinase assessment to measure muscle injury at operation

  10. Postoperative Fentanyl consumption

    Time frame: At 3 days after operation

    Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)

  11. Hospital stay

    Time frame: Within 7 days after operation

    Total hospital stay after surgery

  12. Radiographic complications

    Time frame: every year, up to 5 year after operation,

    Disc degeneration, facet degeneration, re-stenosis, back muscle atrophy, kyphotic change, disc rupture

  13. Satisfaction scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2017
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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