Dataset Information

Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

For sciatica caused by lumbar disc herniation (LDH), the standard surgical technique is conventional microdiscectomy. In recent years, minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM)) have gained increasing interest. PTED and PMTM are considered alternative minimally invasive techniques for the treatment of LDH. Due to insufficient evidence, the differences in efficacy between PTED and PMTM have been debated. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the efficacy and cost-effectiveness of PTED versus PMTM for the treatment of LDH.

Methods and analysis

A total of 280 patients (18-70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited. Patients must have an indication for surgery based on MRI demonstrating LDH with nerve root compression. Patients will be randomised to PTED or PMTM treatment. The primary outcome is Oswestry Disability Index scores. Secondary outcomes include Visual Analogue Scale scores, Short Form 36 health survey scores, physical examination, length of hospital stay, costs and complications. Outcomes will be measured the day following surgery, at 1?week, and at 1, 3, 6, 12 and 24 months after surgical treatment. Physical examination will be conducted at 1?week, 1?month and 12 months after surgery. The non-inferiority margin for the primary outcome is 5.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2018YF010-02). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences.

Trial registration number

ChiCTR1800015727; Pre-results.

SUBMITTER: Liang ZY

PROVIDER: S-EPMC6955567 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial.

Liang Ze Yan ZY Zhuang Yuan Dong YD Chen Chun Mei CM Wang Rui R

BMJ open 20191230 12

<h4>Introduction</h4>For sciatica caused by lumbar disc herniation (LDH), the standard surgical technique is conventional microdiscectomy. In recent years, minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM)) have gained increasing interest. PTED and PMTM are considered alternative minimally invasive techniques for the treatment of LDH. Due to insufficient evidence, the differences in efficacy between PTED and ...[more]

PMID: 31892665

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Project description:Background:Percutaneous endoscopic transforaminal discectomy (PETD) is regarded as a viable alternative option for upper lumbar disc herniation (LDH). However, few studies have evaluated PETD for upper LDH, and no study has compared the advantages of endoscopic procedures versus conventional surgery. The present study was aimed at comparing the surgical outcome and safety of PETD versus conventional open lumbar discectomy in the treatment of upper LDH. Methods:Data from 42 patients treated for upper LDH from July 2015 to July 2018 were retrospectively analyzed, including 21 patients treated with PETD (PETD group) and 21 patients treated with conventional posterior lumbar discectomy (open group). The two groups were compared regarding demographic information, physical examination, radiological evaluations, and perioperative indicators. The clinical outcomes were assessed in accordance with the Oswestry Disability Index (ODI), visual analog scale (VAS), and modified MacNab criteria. Results:The postoperative ODI and VAS scores were significantly improved in both groups compared with the preoperative baseline values (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (. Conclusions:PETD has a similar outcome to the conventional surgical method for the treatment of upper LDH but provides the typical advantages of minimally invasive procedures such as reduced iatrogenic injury, minimal activity restrictions, and accelerated ambulation recovery postoperatively.

Project description:BackgroundTransforaminal percutaneous endoscopic lumbar discectomy (PELD) is a widely used basic technique for lumbar disc herniation (LDH) with advantages including causing less trauma and fast recovery. The secure, efficient, and rapid enlargement of the intervertebral foramen is a key step in PELD procedures. However, the conventional multi-step trephine system for foraminoplasty involves complicated surgical procedures. In this study, we reported an improved one-step foraminoplasty via a large trephine with simplified surgical procedures, reduced radiation exposure, and shortened operative time.Methods70 LDH patients who underwent PELD were retrospectively reviewed in this study. The conventional multi-step trephine system was used for foraminoplasty in 35 patients in the multi-step (MS) group, and the single large trephine was used in the other 35 patients in the one-step (OS) group. Indicators including the operative time, the time to establish the working cannula, intraoperative fluoroscopy times, the radiation dose, and postoperative complications were compared between the MS and OS group.ResultsThe operative time and the time to establish the working cannula in the OS group was significantly shorter than that in the MS group (P < 0.01); intraoperative fluoroscopy times and the radiation dose in the OS group were significantly smaller than those in the MS group (P < 0.01). There was no statistical difference in the incidence of postoperative complications between the two groups (P > 0.05). The postoperative VAS scores and ODI scores (2 days and 3 months after the surgery) were significantly lower than the preoperative scores in both groups (P < 0.01), and there was no statistical difference in VAS scores or ODI scores between the two groups at the same time points (P > 0.05).ConclusionsThe one-step foraminoplasty via a single large trephine is an optimized technique evolving from the conventional multi-step foraminoplasty, showing significant superiority in simplified operation, shorted operative time, and reduced radiation exposure.

Project description:INTRODUCTION:Lumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the treatment of lumbar disc herniation. METHOD AND ANALYSIS:In total, 682 patients between 18 and 70 years of age with >10 weeks of radiating pain or with >6 weeks of excessive radiating pain are to be recruited from participating centres. Patients must have an indication for surgery based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Patients are to be randomised to PTED or open microdiscectomy. The primary outcome is self-reported leg pain measured by the 0-100 mm Visual Analogue Scale. Secondary outcomes include self-reported health and functional status, back pain, self-perceived recovery and a physical examination. Outcomes will be measured the day following surgery, at 2, 4 and 6 weeks, and at 3, 6, 9, 12 and 24 months. Physical examination will be performed at 6 weeks, and 3 and 12 months. An economic evaluation will be performed from a societal perspective and cost questionnaires will be used (eg, EQ-5D-5L). The data will be analysed longitudinally; the non-inferiority margin for the primary outcome is 5. Bootstrapping techniques will be used for the economic evaluation. ETHICS AND DISSEMINATION:This study has received approval of the Medical Ethical Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The results will be published in an international peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER:NCT02602093; Pre-results, recruiting stage.

Dataset Information

Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial.

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