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

Lumbar Herniated Intervertebral Disc Clinical Trial

— BESS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924700
• Other study ID #: BESS_002
• Status: Completed
• Phase: N/A
• Start date: April 28, 2019
• Est. completion date: December 28, 2021

Study information

• Verified date: March 2022
• 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 discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 28, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Herniated Intervertebral Disc

Intervention

Procedure:
• Biportal endoscopy
Biportal endoscopic spine surgery (BESS)
• Microdiscectomy
Using microscope for discectomy

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon
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	at 1 year after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
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 time (minutes)	Intraoperative time in minutes	Immediate after operation
Secondary	Volume of postoperative drainage (ml)	Total drainage after surgery in milli-liter	Within 3 days after operation
Secondary	Number of participants with complete discectomy	After surgery, degree of discectomy was measured using postoperative MRI	Within 3 days after operation
Secondary	Concentration of creatine phosphokinase level in blood	Creatine phosphokinase assessment to measure muscle injury at operation	At 2 day after surgery
Secondary	Volume of postoperative Fentanyl consumption	Total amount of fentanyl consumption after surgery (PCA dose + rescue dose)	At 3 days after operation
Secondary	Times of hospital stay (hours)	Total hospital stay after surgery	Within 7 days after operation
Secondary	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