Evaluation of the efficacy and safety of conventional and biportal endoscopic decompressive laminectomy in patients with lumbar spinal stenosis (ENDO-B trial): a protocol for a prospective, randomized, assessor-blind, multicenter trial.

BACKGROUND: Recent studies on biportal endoscopic spine surgery in patients with lumbar spinal stenosis have reported good clinical results. However, these studies have been limited by the small sample sizes and use of a retrospective study design. Therefore, we aim to compare the efficacy and safety of biportal endoscopic decompressive laminectomy with those of conventional decompressive laminectomy in a multicenter, prospective, randomized controlled trial. METHODS: This study will include 120 patients (60 per group, aged 20-80 years) with 1- or 2-level lumbar spinal stenosis, who will be recruited from six hospitals. The study will be conducted from July 2021 to December 2024. The primary outcome (Oswestry Disability Index at 12 months after surgery) will be evaluated through a modified intention-to-treat method. The secondary outcomes will include the following: visual analog scale score for low back and lower extremity radiating pain, EuroQol 5-dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scars, and some surgery-related variables. Radiographic outcomes will be analyzed using magnetic resonance imaging or computed tomography. All outcomes will be evaluated before the surgery and at 2 weeks, 3 months, 6 months, and 12 months postoperatively. This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for reporting of clinical trial protocols. DISCUSSION: It is hypothesized that the efficacy and safety of biportal endoscopic and conventional decompressive laminectomy will be comparable in patients with lumbar spinal stenosis. The results of this trial will provide a high level of evidence for the efficacy and safety of the biportal endoscopic technique in patients with lumbar spinal stenosis and facilitate the development of clinical practice guidelines. Furthermore, the results of this study may indicate the feasibility of the biportal endoscopic technique for other types of spinal surgery. TRIAL REGISTRATION: The ENDO-B trial is registered at Clinical Research Information Service (CRIS, cris.nih.go.kr ) (KCT0006057; April 52,021).

Saving Stabilizing Structure Treatment With Bilateral-Contralateral Decompression for Spinal Stenosis in Degenerative Spondylolisthesis Using Unilateral Biportal Endoscopy.

OBJECTIVE: This study aimed to evaluate the treatment of spinal stenosis with spondylolisthesis using bilateral-contralateral unilateral biportal endoscopic (UBE) decompression to minimize facet joint damage. METHODS: We retrospectively evaluated 42 patients with grade 1 spondylolisthesis who underwent bilateral-contralateral UBE decompression between July 2018 and September 2019. To identify segmental instability, static and dynamic images from preoperative and postoperative procedures and final follow-up radiographs were reviewed. Lateral radiograph slippage ratio, sagittal motion, and facet joint preservation were evaluated. Clinical assessments were conducted using the visual analogue scale (VAS), Oswestry Disability Index (ODI), and modified MacNab criteria. RESULTS: The average final follow-up period was 26.5 ± 1.3 months. The average preoperative slip percentage was 15.70% ± 5.25%, which worsened to 18.80% ± 5.41% at the final follow-up (p < 0.005). The facet joint preservation rate was 95.6% ± 4.1% on the contralateral side. Improvements in the VAS scores (leg pain: from 7.9 ± 2.2 to 3.1 ± 0.7; p < 0.005; back pain: from 7.2 ± 3.0 to 2.8 ± 1.0; p < 0.005) were observed at the final follow-up. The mean preoperative ODI was 26.19 ± 3.42, which improved to 9.6 ± 1.0 (p < 0.005). Thirteen patients exhibited delayed focal segmental instability following decompression. Despite the absence of symptoms or improvement with conservative treatment in the majority of patients with delayed instability, two patients required fusion surgery to address the instability. Additionally, 2 patients developed facet synovial cysts, while 2 experienced spinous process fractures. CONCLUSION: Bilateral decompression with a contralateral UBE approach could be an effective and alternative treatment method to reduce instability in spinal stenosis with grade 1 spondylolisthesis.

Comparing the efficacy and safety of minimally invasive biportal endoscopic spine surgery versus conventional microscopic discectomy in single-level lumbar herniated intervertebral disc (ENDO-BH Trial): a multicenter, prospective, randomized controlled equivalence trial study protocol.

BACKGROUND: Biportal endoscopic surgery has recently been performed in lumbar discectomy, with advantages over conventional surgery, such as less skin scarring and muscle damage. However, the clinical results have not been established. Although previous studies reported no difference between the biportal endoscopic and microscopic discectomy clinical results, the evidence was weak. Therefore, this study aims to evaluate the efficacy and safety of the biportal endoscopic discectomy versus the microscopic discectomy. METHODS: This prospective multicenter randomized controlled equivalence trial is designed to compare the efficacy and safety outcomes of patients who underwent lumbar discectomy using biportal endoscopy or microscopy. We will include 100 participants (50 per group) with a lumbar herniated disc. The primary outcome will be the Oswestry Disability Index (ODI) score 12 months after surgery based on a modified intention-to-treat strategy. The secondary outcomes will include the visual analog scale score for low back and lower extremity radiating pain, the ODI score, the Euro-Qol-5-Dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scar, and surgery-related variables, such as postoperative drainage, operation time, admission duration, postoperative creatine kinase, and implementation status of conversion to open surgery. Radiographic outcomes will also be analyzed using magnetic resonance imaging (MRI) or computed tomography (CT) and simple radiographs. Safety will be assessed by evaluating all adverse and severe adverse events and surgery-related effects. The participants will be assessed by a blinded assessor before surgery (baseline) and 2 weeks and 3, 6, and 12 months after surgery. DISCUSSION: This trial will be the first prospective, multicenter, randomized controlled trial to analyze the efficacy and safety of biportal endoscopic discectomy in lumbar herniated disc. This trial is designed for evaluating the equivalence of the results between biportal endoscopic and microscopic discectomy including adequate sample size, blinded analyses, and prospective registration to reduce bias. This trial will provide enough data on the effectiveness and safety of biportal endoscopic surgery and will be an important study that allows clear conclusions. TRIAL REGISTRATION: Clinical Research Information Service (cris.nih.go.kr.) ( KCT0006191 ). Registered on 27 March 2021.

Clinical and radiological results of indirect decompression after anterior lumbar interbody fusion in central spinal canal stenosis.

OBJECTIVE: Whereas the benefits of indirect decompression after lateral lumbar interbody fusion are well known, the effects of anterior lumbar interbody fusion (ALIF) have not yet been verified. The purpose of this study was to evaluate the clinical and radiological effects of indirect decompression after ALIF for central spinal canal stenosis. In this report, along with the many advantages of the anterior approach, the authors share cases with good outcomes that they have encountered. METHODS: The authors performed a retrospective analysis of 64 consecutive patients who underwent ALIF for central spinal canal stenosis with instability and mixed foraminal stenosis between January 2015 and December 2018 at their hospital. Clinical assessments were performed using the visual analog scale score, the Oswestry Disability Index, and the modified Macnab criteria. The radiographic parameters were determined from pre- and postoperative cross-sectional MRI scans of the spinal canal and were compared to evaluate neural decompression after ALIF. The average follow-up period was 23.3 ± 1.3 months. RESULTS: All clinical parameters, including the visual analog scale score, Oswestry Disability Index, and modified Macnab criteria, improved significantly. The mean operative duration was 254.8 ± 60.8 minutes, and the intraoperative bleeding volume was 179.8 ± 119.3 ml. In the radiological evaluation, radiological parameters of the cross-sections of the spinal canal showed substantial development. The spinal canal size improved by an average of 43.3% (p < 0.001) after surgery. No major complications occurred; however, aspiration guided by ultrasonography was performed in 2 patients because of a pseudocyst and fluid collection. CONCLUSIONS: ALIF can serve as a suitable alternative to extensive posterior approaches. The authors suggest that ALIF can be used for decompression in central spinal canal stenosis as well as restoration of the foraminal dimensions, thus allowing decompression of the nerve roots.

Economic evaluation of prostate cancer screening test as a national cancer screening program in South Korea.

BACKGROUND: Prostate cancer is rapidly increasing in Korea and professional societies have requested adding prostate specific antigen (PSA) testing to the National Cancer Screening Program (NCSP), but this started a controversy in Korea and neutral evidence on this issue is required more than ever. The purpose of this study was to provide economic evidence to the decision makers of the NCSP. MATERIALS AND METHODS: A cost-utility analysis was performed on the adoption of PSA screening program among men aged 50-74-years in Korea from the healthcare system perspective. Several data sources were used for the cost-utility analysis, including general health screening data, the Korea Central Cancer Registry, national insurance claims data, and cause of mortality from the National Statistical Office. To solicit the utility index of prostate cancer, a face-to-face interview for typical men aged 40 to 69 was conducted using a Time-Trade Off method. RESULTS: As a result, the increase of effectiveness was estimated to be very low, when adopting PSA screening, and the incremental cost effectiveness ratio (ICER) was analyzed as about 94 million KRW. Sensitivity analyses were performed on the incidence rate, screening rate, cancer stage distribution, utility index, and treatment costs but the results were consistent with the base analysis. CONCLUSIONS: Under Korean circumstances with a relatively low incidence rate of prostate cancer, PSA screening is not cost-effective. Therefore, we conclude that adopting national prostate cancer screening would not be beneficial until further evidence is provided in the future.