NDLI: 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

Content Provider	Springer Nature : BioMed Central
Author	Park, Hyun-Jin Park, Sang-Min Song, Kwang-Sup Kim, Ho-Joong Park, Si-Young Kang, Taewook Kang, Min-Seok Heo, Dong-Hwa Park, Choon-Keun Lee, Dong-Geun Hwang, Jin-Sub Jang, Jae-Won Kim, Jun-Young Kim, Jin-Sung Lee, Hong-Jae Yoon, Joon-Hyeok Park, Chang-Won You, Ki-Han
Abstract	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).
Related Links	https://bmcmusculoskeletdisord.biomedcentral.com/counter/pdf/10.1186/s12891-021-04959-2.pdf
Ending Page	8
Page Count	8
Starting Page	1
File Format	HTM / HTML
ISSN	14712474
DOI	10.1186/s12891-021-04959-2
Journal	BMC Musculoskeletal Disorders
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2021-12-20
Access Restriction	Open
Subject Keyword	Orthopedics Rehabilitation Rheumatology Sports Medicine Internal Medicine Epidemiology Lumbar spinal stenosis Biportal endoscopic spine surgery Decompressive laminectomy
Content Type	Text
Resource Type	Article
Subject	Orthopedics and Sports Medicine Rheumatology
Journal Impact Factor	2.2/2023
5-Year Journal Impact Factor	2.6/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Evaluation of the efficacy and safety of conventional and interlaminar full-endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-F trial): Protocol for a prospective, randomized, multicenter trial.

Comparative efficacy of unilateral biportal and percutaneous endoscopic techniques in unilateral laminectomy for bilateral decompression (ULBD) for lumbar spinal stenosis

Delta large-channel endoscopy versus unilateral biportal endoscopy decompressive laminectomy for lumbar spinal stenosis: a prospective randomized controlled trial

A comparison study of percutaneous endoscopic decompression and posterior decompressive laminectomy in the treatment of thoracic spinal stenosis

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

Unilateral biportal endoscopic lumbar interbody fusion (ULIF) versus endoscopic transforaminal lumbar interbody fusion (Endo-TLIF) in the treatment of lumbar spinal stenosis along with intervertebral disc herniation: a retrospective analysis

Biomechanical comparison of lumbar spine instability between laminectomy and bilateral laminotomy for spinal stenosis syndrome – an experimental study in porcine model

Effects of “fixation-fusion” sequence of lumbar surgery on surgical outcomes for patients with lumbar spinal stenosis: study protocol for a multicenter randomized controlled trial

Efficacy of Biportal Endoscopic Spine Surgery for Lumbar Spinal Stenosis.

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

Similar Documents

Evaluation of the efficacy and safety of conventional and interlaminar full-endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-F trial): Protocol for a prospective, randomized, multicenter trial.

Comparative efficacy of unilateral biportal and percutaneous endoscopic techniques in unilateral laminectomy for bilateral decompression (ULBD) for lumbar spinal stenosis

Delta large-channel endoscopy versus unilateral biportal endoscopy decompressive laminectomy for lumbar spinal stenosis: a prospective randomized controlled trial

A comparison study of percutaneous endoscopic decompression and posterior decompressive laminectomy in the treatment of thoracic spinal stenosis

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

Unilateral biportal endoscopic lumbar interbody fusion (ULIF) versus endoscopic transforaminal lumbar interbody fusion (Endo-TLIF) in the treatment of lumbar spinal stenosis along with intervertebral disc herniation: a retrospective analysis

Biomechanical comparison of lumbar spine instability between laminectomy and bilateral laminotomy for spinal stenosis syndrome – an experimental study in porcine model

Effects of “fixation-fusion” sequence of lumbar surgery on surgical outcomes for patients with lumbar spinal stenosis: study protocol for a multicenter randomized controlled trial

Efficacy of Biportal Endoscopic Spine Surgery for Lumbar Spinal Stenosis.

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