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Completed

NCT Number: NCT03924700

Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial

This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine

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Key information

Conditions

Lumbar Herniated Intervertebral Disc Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

20 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

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Biportal endoscopy

Procedure

Biportal endoscopic spine surgery (BESS)

Microdiscectomy

Procedure

Using microscope for discectomy

Primary outcomes

  1. Oswestry disability index (ODI)

    Time frame: at 1 year after surgery

    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. Change from baseline 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.

  2. Change from baseline 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.

  3. Change from baseline EuroQoL-5 dimension (EQ-5D) value

    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. Rated level can be coded as a number 1 to 5, which indicates having no problems for 1, and having extreme problems for 5. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions). EQ-5D health states may be converted into a single index value. The index values are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions. The value sets are anchored on 11111 = 1 and 55555 = 0 and can therefore be used in QALY calculations.

  4. Change from baseline PainDETECT score

    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.

  5. 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)

  6. Operation duration time (minutes)

    Time frame: Immediate after operation

    Intraoperative time in minutes

  7. Volume of postoperative drainage (ml)

    Time frame: Within 3 days after operation

    Total drainage after surgery in milli-liter

  8. Number of participants with complete discectomy

    Time frame: Within 3 days after operation

    After surgery, degree of discectomy was measured using postoperative MRI

  9. Concentration of creatine phosphokinase level in blood

    Time frame: At 2 day after surgery

    Creatine phosphokinase assessment to measure muscle injury at operation

  10. Volume of postoperative Fentanyl consumption

    Time frame: At 3 days after operation

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

  11. Times of hospital stay (hours)

    Time frame: Within 7 days after operation

    Total hospital stay after surgery

  12. Number of radiographic complications

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

    Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture...

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Acronym: BESS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2019
Registry last updated
Mar 23, 2022

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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