==== Front Medicine (Baltimore) MD Medicine 0025-7974 1536-5964 Lippincott Williams & Wilkins Hagerstown, MD 37390280 00052 10.1097/MD.0000000000034188 3 3300 Research Article Observational Study Endoscopic discectomy of the herniated intervertebral disc and changes in quality-of-life EQ-5D-5L analysis Rapčan Róbert MD, PhD, FIPP tirpak@europainclinics.com abc https://orcid.org/0000-0003-4352-4501 Kočan Ladislav MD, PhD, FIPP d * Witkovsky Viktor CSc witkovsky@savba.sk e Rapčanová Simona MD rapcanova@europainclinics.com f Mláka Juraj MD, FIPP, EDRA mlaka@europainclinics.com b Tirpák Róbert MD, FIPP tirpak@europainclinics.com b Burianek Miroslav MD miroslav.gajdos@upjs.sk f Kočanová Hana MD hokovahana@gmail.com g Vašková Janka PhD janka.vaskova@upjs.sk h Gajdoš Miroslav CSc miroslav.gajdos@upjs.sk i a Europainclinics, Bratislava, Slovak Republic b Europainclinics, Poliklinika Terasa, Košice, Slovak Republic c Europainclinics, Bardejov, Slovak Republic, Slovak Republic d Clinic of Anaesthesiology and Intensive Care Medicine, East Slovak Institute of Cardiovascular Disease, Košice, Slovak Republic e Institute of Measurement Science, Slovak Academy of Sciences, Bratislava, Slovak Republic f Europainclinics, Prague, Czech Republic g Clinic of Anaesthesiology and Intensive Care Medicine, Railway Hospital and Clinic Košice, Košice, Slovak Republic h Department of Medical and Clinical Biochemistry, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Trieda SNP 1, Košice, Slovak Republic i Department of Neurosurgery, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, and Louis Pasteur University Hospital, Košice, Slovak Republic. * Correspondence: Ladislav Kočan, Clinic of Anaesthesiology and Intensive Care Medicine, East Slovak Institute of Cardiovascular Disease, Ondavská 8, Košice 04011, Slovak Republic (e-mail: kocanladislav@yahoo.com). 30 6 2023 30 6 2023 102 26 e341888 5 2023 12 6 2023 13 6 2023 Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. 2023 https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Herniated lumbar discs are a common cause of low back pain, which can negatively impact the quality of life of working-age individuals. This study aimed to evaluate changes in the quality of life in patients with sciatica who underwent endoscopic discectomy, a minimally invasive surgical procedure. The study (ClinicalTrials.gov NCT02742311) included 470 patients who underwent transforaminal, interlaminar, or translaminar endoscopic discectomy. Quality of life and pain perception were evaluated by comparing statistically weighted values of EQ-5D-5L, EQ-VAS, Oswestry disability index, and numerical pain scales for lower limb and back pain before and 12 months after the endoscopic procedure. After the procedure, there was a significant improvement in the reduction of back and lower limb pain, as well as in all monitored questionnaires (P < .001), which persisted 12 months after the endoscopy. All evaluated dimensions of the EQ-5D-5L questionnaire indicated a significant improvement in the assessed quality of life (P < .001). The study showed that percutaneous endoscopic lumbar discectomy is an effective pain-treating intervention that can improve the quality of life. There was no observed difference in the percentage of complications or re-herniations when comparing the transforaminal and interlaminar, approaches. back pain discectomy EQ-5D-5L questionnaire leg pain quality of life OPEN-ACCESSTRUE ==== Body pmc1. Introduction Low back pain with sciatica caused by lumbar disc herniation (LDH) affects nearly 60% of patients and is increasingly common as the global population ages. This condition is particularly prevalent in the working-age population, with 70% of disability caused by LDH occurring in people aged 20 to 65 years. The diagnosis of LHD is confirmed by magnetic resonance imaging, and the major symptoms include low back pain and sciatica. However, there is no clear evidence regarding the best treatment approach.[1] Recently, percutaneous endoscopic lumbar discectomy (PELD) has been used as an alternative to open discectomy. PELD is a minimally invasive technique that reduces the use of general anesthesia and results in less damage to surrounding soft tissues and paravertebral musculature, faster wound healing time, reduced spine instability, and shorter hospitalization.[2–4] The health-conditioned quality of life in patients with LHD is a result of both subjective perception of the disease and objective conditions.[5–7] Therefore, various questionnaires are used to evaluate the health-related quality of life (HRQoL) of patients undergoing treatment.[8,9] This study aimed to assess changes in the quality of life in patients with sciatica who underwent endoscopic discectomy using the EuroQol 5-dimension questionnaire. The study also evaluated the Oswestry disability index (ODI), the numerical scale of quality of life, and numerical scales of leg pain and back pain. The statistical weight values for the studied countries were determined. The results showed significant improvements in all monitored parameters, including a reduction in back and lower limb pain, as well as improvements in HRQoL that persisted 12 months after the endoscopic procedure. PELD was found to be an effective intervention for treating pain, and no significant differences were observed in complications or re-herniations when comparing the different approaches. 2. Materials and methods 2.1. Patients Between January 2016 and June 2021, we enrolled 470 patients who underwent ELD. These patients were between the ages of 18 to 80 years old and were classified according to their physical status using the American Society of Anesthesiology grading system (classes I, II, and III) (Fig. 1). The study was conducted in pain clinics located in Bratislava, Bardejov, Košice, Prague, and Brno in the Slovak and Czech Republic, and approved by a clinical investigation and recruitment process. Figure 1. Flow chart of patient selection, enrollment, and follow-up in the study. Inclusion criteria for the study were: being 18 years old or older, having signed informed consent, presenting with magnetic resonance imaging evidence of intervertebral disc herniation or sequestration, and experiencing permanent pain radiating to the lower limbs despite prior epidural steroid injection or similar interventions in conjunction with conservative treatment (such as rehabilitation and pharmacological treatment). Exclusion criteria were: bleeding diathesis, urination or defecation problems, presence of infection or neoplasm, possible pregnancy, and patient disapproval. The procedure was performed by either a spine surgeon or an interventional pain management specialist, and each patient received a unique clinical trial ID number. The primary outcomes of the study were the intensity of pain radiating to the back and legs, measured using the numerical rating scale (NRS) (ranging from 0 to 10), and the evaluation of the ODI, which assesses the extent of low back pain-related disability on a scale of 0 to 100%. Scores between 0 and 20% indicate minimal disability, while scores between 81 and 100% indicate bedridden patients or those with exaggerated symptoms. We also assessed the EuroQol survey using the EQ-5D-5L questionnaire. The descriptive system consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with scores ranging from 1 to 5 (representing the best to worst state). The EuroQol survey also includes the EQ-VAS vertical visual analog scale, which utilizes a grading scale from 0 to 100 to evaluate the quality of life. A score of 0 indicates “The worst health you can imagine,” while a score of 100 indicates “The best health you can imagine.” No significant changes were made to the methods after the study commenced. Prior to the operation, the NRS for back and leg pain, EQ-VAS, and ODI were assessed in one of the pain clinics participating in the study. The second assessment was conducted 12 months after the procedure, either during an appointment in one of the included centers or via a phone call follow-up, to assess pain severity by NRS and neurological state. 2.2. Surgery 2.2.1. Transforaminal endoscopic discectomy (TFED). This technique uses a natural entrance into the spinal canal (neuroforamen). The working channel for the endoscope is inserted through the paravertebral musculature latero-medially. During TFED, it is not necessary to disrupt the dorsal border of the spinal canal (the skeletal lamina of the vertebra and the ligamentum flavum). The risk of postoperative fibrosis formation is, therefore, minimal. 2.2.2. Interlaminar endoscopic discectomy (ILED). With more central protrusions that are harder to reach or more voluminous sequesters, especially at the L5/S1 level, the interlaminar approach was used. The working channel with the endoscope was introduced in the midline, very similar to a microdiscectomy. To enter the spinal canal, only a small part of the ligamentum flavum needs to be removed. The dural sac is then moved medially with a special maneuver to enable working in the central part of the channel. 2.2.3. Translaminar endoscopic discectomy. In cases, where entry into the spinal canal slightly above or below the interlaminar windows was desirable, translaminar endoscopic discectomy was used. The working channel for the affected disc level was inserted at the lateral inferior part of the lamina. Part of the lamina and ligamentum flavum are removed. This approach is very similar to ILED. 2.3. Anesthesia The perioperative management of patients in our study involved several components. Prior to the operation, patients were premedicated with midazolam in a peroral dose ranging from 4 to 7.5 mg. During the procedure, standard monitoring was conducted, including electrocardiography, monitoring of oxygen saturation, and noninvasive blood pressure measurements. During the procedures, the patients were positioned in the prone position. We employed the propofol-remifentanil target-controlled infusion sedation technique. Throughout the sedation process, the patients maintained consciousness and were responsive to our inquiries. They breathed spontaneously with the assistance of oxygen masks. The target-controlled infusion sedation technique was maintained by administering a continuous infusion of remifentanil at a rate ranging from 0.05 to 2 µg/kg/min. Additionally, propofol was administered with dosages varying from 0.5 to 4.0 μg/ml, depending on the specific needs of the surgical procedure. During the operation, the surgical operator infiltrated the wound and operating canal with a mixture of local anesthetics. This combination consisted of 0.5% levobupivacaine and 1% trimecaine, with a total volume of up to 20 ml. After the operation, patients were transferred to the recovery room where they were observed for up to 3 hours. During this time, standard monitoring was performed based on the patient’s clinical situation. This included continuous monitoring of vital signs such as heart rate, blood pressure, respiratory rate, and oxygen saturation. Additionally, any specific postoperative complications or concerns were addressed and managed accordingly. To manage postoperative pain, patients received intravenous paracetamol at a dose of 1 g. For at-home medication, patients were prescribed tramadol at a dosage of 100 mg every 12 hours, diclofenac at a dosage of 75 mg per day, and paracetamol at a dosage of 500 mg every 8 hours. These medications and interventions were part of our standardized protocol for perioperative management in our study. They were designed to ensure adequate pain control and patient comfort during the postoperative period. 2.4. Statistical methods Statistical analysis of the EQ-5D-5L questionnaire scores (in each of the 5 dimensions considered) was conducted using Wilcoxon rank-sum test and, alternatively, the estimated reliability parameter (together with the associated confidence intervals [CIs]). The Wilcoxon rank-sum test is a standard statistical, nonparametric test that checks whether 2 independent samples come from continuous probability distributions (populations) with the same medians. Although the original version of the test was designed to compare continuous distributions, a simple generalization is possible for applications with discrete distributions (which is the case when we try to compare the distribution of questionnaire scores reflecting the degree of the symptom tested on a scale from 1 to 5). Secondly, as an alternative, we have used the estimated reliability parameter R=Prob(X1 year after endoscopic surgery (P < .001). We also calculated the statistically weighted questionnaire values for each dimension of the EQ-5D-5L questionnaire in the Slovak and Czech region, which also indicate a significant improvement in social quality of life (P < .001). Despite our study involving patients with a mean age of 46.3 years, the clinical improvement, reduction in lower limb pain, and improved quality of life after surgery are consistent with a 2-year follow-up study by Peng et al[6] in younger patients with a mean age of 35.6 years. An interesting finding from a prospective cohort study by Kapetanakis et al[4] is that neither gender, muscle mass, nor body mass index has a significant effect on the final outcome of endoscopic discectomy. A systematic analysis of clinical trials comparing the effectiveness of transforaminal and interlaminar endoscopic approaches in treating LHD, which reviewed 26 clinical trials involving 3294 patients, demonstrated a significant therapeutic benefit with both interventional approaches. However, the transforaminal approach was associated with higher efficacy, shorter operation time, and lower blood loss.[7] In our clinical study, we selected the safest and most effective possible approach for each patient. For patients with higher levels of L3/4 and L4/5 herniations, we preferred the transforaminal approach. For herniations in the lower spinal segments L5/S1 due to anatomical conditions of the pelvis, we chose the interlaminar approach more often than the transforaminal approach. Comparing both approaches, we did not observe a higher percentage of complications or re-herniation. We consider analgosedation with monitoring as a safe and beneficial method for endoscopic discectomy. It allows for effective communication with the patient, ensuring safety and minimizing the risk of nerve damage. Additionally, it promotes early recovery and a faster return to consciousness, while reducing the occurrence of postoperative nausea and vomiting. Despite potential challenges in airway access, we did not encounter any cases of acute respiratory failure requiring intubation. 4.1. Limitations Our clinical trial on acute sciatica treatment had limitations that should be addressed. Firstly, using a prospective observational design instead of a randomized controlled trial introduced the potential for selection bias. The absence of a control group made it challenging to compare treatment effectiveness accurately. Including a control group would have enabled a more robust evaluation of endoscopic discectomy, microdiscectomy, and conservative treatments. The study involved 470 patients, but a broader age range (18–79 years) may have influenced the results. Additionally, a loss to follow-up of 39 patients resulted in missing data for statistical analysis, potentially impacting the robustness and generalizability of our findings. Future studies should minimize loss to follow-up and ensure comprehensive data collection. Recognizing these limitations is crucial for interpreting our findings accurately and planning future research in acute sciatica treatment. 5. Conclusions Endoscopic discectomy is a highly effective minimally invasive surgical method for treating LHD, with a significant impact on the patient’s clinical state. Clinical assessments of the quality of life using different types of measurement instruments are useful in demonstrating the efficacy of pain-treating interventions. Author contributions Conceptualization: Ladislav Kočan, Juraj Mláka, Róbert Tirpák. Data curation: Róbert Rapčan, Ladislav Kočan, Viktor Witkovsky. Formal analysis: Róbert Rapčan, Ladislav Kočan, Viktor Witkovsky, Miroslav Gajdoš. Funding acquisition: Ladislav Kočan, Simona Rapčanová, Juraj Mláka. Investigation: Ladislav Kočan, Viktor Witkovsky, Simona Rapčanová, Juraj Mláka, Róbert Tirpák, Hana Kočanová. Methodology: Ladislav Kočan, Hana Kočanová. Project administration: Ladislav Kočan, Janka Vašková. Resources: Ladislav Kočan, Miroslav Burianek, Janka Vašková. Software: Róbert Rapčan. Supervision: Róbert Rapčan, Ladislav Kočan, Juraj Mláka. Validation: Róbert Rapčan, Ladislav Kočan, Miroslav Burianek. Visualization: Miroslav Burianek. Writing – original draft: Ladislav Kočan, Simona Rapčanová, Róbert Tirpák, Hana Kočanová. Writing – review & editing: Ladislav Kočan, Simona Rapčanová, Hana Kočanová. Abbreviations: CI confidence interval HRQoL health-related quality of life ILED interlaminar endoscopic discectomy LDH lumbar disc herniation NRS numerical rating scale ODI Oswestry disability index PELD percutaneous endoscopic lumbar discectomy TFED transforaminal endoscopic discectomy The authors have no funding to disclose. The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee of Faculty of Medicine, Pavol Jozef Šafárik University in Košice No EK:9N-2015. The study was registered in ClinicalTrials.gov (NCT02742311, April 19, 2016). Written informed consent has been obtained from the patients to publish this paper. The authors have no conflicts of interest to disclose. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. How to cite this article: Rapčan R, Kočan L, Witkovsky V, Rapčanová S, Mláka J, Tirpák R, Burianek M, Kočanová H, Vašková J, Gajdoš M. Endoscopic discectomy of the herniated intervertebral disc and changes in quality-of-life EQ-5D-5L analysis. Medicine 2023;102:26(e34188). ==== Refs References [1] Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396 :1204–22.33069326 [2] Zhou T Ma T Gu Y . Percutaneous Transforaminal Endoscopic Surgery (PTES) for treatment of lumbar degenerative disease in patients with underlying diseases: a retrospective cohort study of 196 Cases. J Pain Res. 2023;16 :1137–47.37025953 [3] van der Windt DA Simons E Riphagen II . Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev. 2010;2 :CD007431. [4] Gadjradj P Biswadjiet H Amelink J . 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