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Open Access 01-12-2022 | Lumbar Prolapsed Disc | Study protocol

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

Authors: Sang-Min Park, Kwang-Sup Song, Ho-Joong Kim, Si-Young Park, Taewook Kang, Min-Seok Kang, Dong Hwa Heo, Choon Keun Park, Dong-Geun Lee, Jin Sub Hwang, Jae-Won Jang, Jun Young Kim, Jin-Sung Kim, Hong-Jae Lee, Ki-Han You, Hyun-Jin Park

Published in: Trials | Issue 1/2022

Abstract

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

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Title: 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
Authors: Sang-Min Park
Kwang-Sup Song
Ho-Joong Kim
Si-Young Park
Taewook Kang
Min-Seok Kang
Dong Hwa Heo
Choon Keun Park
Dong-Geun Lee
Jin Sub Hwang
Jae-Won Jang
Jun Young Kim
Jin-Sung Kim
Hong-Jae Lee
Ki-Han You
Hyun-Jin Park
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Lumbar Prolapsed Disc
Lumbar Disc Herniation
Lumbar Disc Herniation
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06094-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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