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

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

doi:10.1186/s13063-022-06094-2

Abstract

BackgroundBiportal 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.MethodsThis 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.DiscussionThis 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 registrationClinical Research Information Service (cris.nih.go.kr.) (KCT0006191). Registered on 27 March 2021

Highlights

Biportal endoscopic surgery has recently been performed in lumbar discectomy, with advantages over conventional surgery, such as less skin scarring and muscle damage
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
In 1977, Caspar et al introduced microscopic discectomy, a less invasive method compared to conventional technique [23]

Summary

Introduction

Biportal endoscopic surgery has recently been performed in lumbar discectomy, with advantages over conventional surgery, such as less skin scarring and muscle damage. Previous studies reported no difference between the biportal endoscopic and microscopic discectomy clinical results, the evidence was weak. Microscopic discectomy, a minimally invasive surgery, is performed to address the problems of conventional open discectomy [3]. Microscopic discectomy, which uses a tubular retractor and an endoscope, is the most commonly used minimally invasive surgery method [1]. Invasive surgery has many advantages over conventional methods, and reports indicate that the clinical results do not differ from conventional methods [3, 4]. According to a randomized controlled trial by Gibson JNA et al, full-endoscopic discectomy showed similar functional improvement compared to microscopic discectomy, and it showed reduced length of hospital stay and less leg pain at 2 years after surgery [5]. The procedure is difficult to learn, has a narrow field of view and a long operation time, and may cause problems, such as insufficient discectomy [6]

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