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

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

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

Study Overview

• Status: Completed
• Conditions: Lumbar Herniated Intervertebral Disc
• Intervention / Treatment: Procedure: Biportal endoscopy; Procedure: Microdiscectomy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Gyounggido
    • Seongnam-si, Gyounggido, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biportal endoscopic discectomy; Biportal endoscopic discectomy for lumbar herniated intervertebral disc	Procedure: Biportal endoscopy; Biportal endoscopic spine surgery (BESS)
Active Comparator: Microdiscectomy; Microdiscectomy for lumbar herniated intervertebral disc	Procedure: Microdiscectomy; Using microscope for discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from baseline 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.	3, 6, and 12, months, and every year, up to 5 year after operation
Change from baseline 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
Change from baseline EuroQoL-5 dimension (EQ-5D) value	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.	3, 6, and 12, months, and every year, up to 5 year after operation
Change from baseline PainDETECT score	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
Operation duration time (minutes)	Intraoperative time in minutes	Immediate after operation
Volume of postoperative drainage (ml)	Total drainage after surgery in milli-liter	Within 3 days after operation
Number of participants with complete discectomy	After surgery, degree of discectomy was measured using postoperative MRI	Within 3 days after operation
Concentration of creatine phosphokinase level in blood	Creatine phosphokinase assessment to measure muscle injury at operation	At 2 day after surgery
Volume of postoperative Fentanyl consumption	Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)	At 3 days after operation
Times of hospital stay (hours)	Total hospital stay after surgery	Within 7 days after operation
Number of radiographic complications	Radiographic complications includes disc degeneration, facet degeneration, re-ruptured disc, back muscle atrophy, kyphotic change, disc rupture...	every year, up to 5 year after operation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Discectomy; Herniated intervertebral disc; Microscope; Biportal endoscopy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: BESS_002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No