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RESEARCH ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 2  |  Page : 45-51

Percutaneous transforaminal endoscopic discectomy for treatment of degenerative lumbar disc herniation in older adult patients: study protocol for a randomized controlled trial and preliminary results


Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, Dalian, Liaoning Province, China

Correspondence Address:
Li-Chen Xu
Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, Dalian, Liaoning Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3975.235147

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Background and objectives: Percutaneous transforaminal endoscopic discectomy (PTED) is a major minimally invasive surgical method for the treatment of degenerative lumbar disc herniation. The choice of posture for patients undergoing PTED is controversial. Surgeons tend to perform PTED with the patient in the prone position rather than in the lateral position. Little is documented on which posture has higher efficacy and safety. This study will be performed to investigate the efficacy and safety of the prone position versus lateral position for older adult patients undergoing PTED for the treatment of degenerative lumbar disc herniation. Design: A prospective, single-center, open-label, randomized controlled trial. Methods: This study will include 168 older adult patients with degenerative lumbar intervertebral disc herniation who receive treatment in the Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, China. These patients will be randomized to undergo PTED in either the prone or lateral position (n = 84 patients in each surgical position). After surgery, all patients will be followed up for 2, 6, and 12 months. Outcome measures and preliminary results: The primary outcome is the Oswestry Disability Index at 12 months postoperatively. This index is used to evaluate the improvement in low back pain. The secondary outcomes are the Oswestry Disability Index preoperatively (at baseline) and at 2 and 6 months postoperatively; X-ray morphology of the lumbar spine, Visual Analog Scale score, and Japanese Orthopaedic Association score preoperatively and at 2, 6, and 12 months postoperatively; modified MacNab grade at 2, 6, and 12 months postoperatively; partial pressures of oxygen and carbon dioxide preoperatively, intraoperatively, and 1 hour postoperatively; mean arterial pressure, Likert score, and times and doses of vasopressor used intraoperatively; and the incidence of recurrent lumbar intervertebral disc herniation and incidence of adverse reactions 12 months postoperatively. The results of 54 patients included in a pilot study of PTED showed that regardless of use of the prone position (n = 24) or lateral position (n = 28), the Visual Analog Scale score and Oswestry Disability Index at 2 months postoperatively were significantly lower than those before surgery (P < 0.05). Intraoperative arterial blood gas analysis revealed that the partial pressures of oxygen and carbon dioxide were significantly different between patients in the prone and lateral positions (P < 0.05). Discussion: Based on the pilot study, future studies involving larger sample sizes are needed to investigate the short- and medium-term efficacy and safety of the prone versus lateral position for patients undergoing PTED for degenerative lumbar intervertebral disc herniation and to identify a better surgical posture suitable for older adult patients. Ethics and dissemination: This study was approved by Medical Ethics Committee of Dalian Municipal Central Hospital Affiliated to Dalian Medical University, China in May 2018 (approval No. 2018-012-01). This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from the participants. The study protocol was designed in December 2017. Patient recruitment will begin in August 2018 and end in August 2019. Data analysis will begin in October 2020 and end in November 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016399). Protocol version: 1.0.


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