Open AccessA randomized study protocol of microendoscopic versus open discectomy in treatment of lumbar disc herniation
Author(s) -
Yunlong Zhou,
Zhiqiang Liu,
Fei Lei,
Kai Xie,
Xufeng Jia
Publication year - 2020
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000021361
Subject(s) - medicine , randomized controlled trial , institutional review board , surgery , radiological weapon , lumbar disc herniation , discectomy , protocol (science) , clinical trial , disc herniation , lumbar , physical therapy , alternative medicine , pathology
Abstract Background: Lumbar disk herniation (LDH) is one of the main causes of discogenic low back pain. However, the evidence comparing different approaches for discectomy has lacked definitive conclusions, with conflicting results regarding the benefit of minimally invasive versus open techniques for LDH. We are now conducting a randomized controlled trial to figure out whether or not microendoscopic discectomy yields better clinical outcomes and causes less surgical trauma than open surgery. Methods: This prospective, randomized, single-blind, controlled, superiority clinical trial was approved by the institutional review board in the People's Hospital of Jianyang City. The conduct of this study followed the Declaration of Helsinki principles and the reporting of this study adhered to the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials. Subjects were randomized into 2 groups as follows: open surgery and microendoscopic group. The outcomes included pain score, functional outcome, satisfaction rate, radiological outcomes, and complications. The statistical analyses in this study were performed using the Statistical Package for the Social Sciences 20.0 software. P < .05 was accepted as statistically significant. Results: The hypothesis was that the open technique would achieve similar clinical outcomes as compared to the microendoscopic technique in LDH. Trial registration: This study protocol was registered in Research Registry (researchregistry5708).