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Open discectomy vs microdiscectomy for lumbar disc herniation - a protocol for a pragmatic comparative effectiveness study.

ABSTRACT: Introduction: Since the introduction of lumbar microdiscectomy in the 1970's, many studies have attempted to compare the effectiveness of this method with that of standard open discectomy with conflicting results. This observational study is designed to compare the relative effectiveness of microdiscectomy (MD) with open discectomy (OD) for treating lumbar disc herniation, -within a large cohort, recruited from daily clinical practice. Methods and analysis: This study will include patients registered in the Norwegian Registry for Spine Surgery (NORspine). This clinical registry collects prospective data, including preoperative and postoperative outcome measures as well as individual and demographic parameters. The primary outcome is change in Oswestry disability index between baseline and 12 months after surgery. Secondary outcome measures are improvement of leg pain and changes in health related quality of life measured by the Euro-Qol-5D between baseline and 12 months after surgery, complications to surgery, duration of surgical procedures and length of hospital stay.

SUBMITTER: Sorlie A

PROVIDER: S-EPMC5089132 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Open discectomy vs microdiscectomy for lumbar disc herniation - a protocol for a pragmatic comparative effectiveness study.

Sørlie Andreas A Gulati Sasha S Giannadakis Charalampis C Carlsen Sven M SM Salvesen Øyvind Ø Nygaard Øystein P ØP Solberg Tore K TK

F1000Research 20160902

<b>Introduction</b>: Since the introduction of lumbar microdiscectomy in the 1970's, many studies have attempted to compare the effectiveness of this method with that of standard open discectomy with conflicting results. This observational study is designed to compare the relative effectiveness of microdiscectomy (MD) with open discectomy (OD) for treating lumbar disc herniation, -within a large cohort, recruited from daily clinical practice. <b>Methods and analysis:</b> This study will inclu ...[more]

PMID: 27853515

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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:BackgroundFenestration discectomy, for symptomatic lumbar disc herniation, is the most common surgical procedure in spine surgery. It can be done by open or microscopic procedures. This study compared the results of fenestration microdiscectomy with open fenestration discectomy in the treatment of symptomatic lumbar disc herniation as a relation to the functional outcome, leg pain, back pain, hospital stay, returns to daily activity, cost, recurrence, reoperation and type of surgery for recurrent disc herniation.Methods60 patients age (29 - 50 years), with L4-L5 disc herniation, are divided randomly into group A- 30 patients underwent an open fenestration discectomy- and group B- 30 patients underwent fenestration microdiscectomy. All patients are assessed at 1 week, 3 months, 6 months, 12 months after surgery for Oswestry disability index and Visual analogue scale for back pain and leg pain and followed up for 4 years.ResultsIn both groups, all patients have minimal disability by Oswestry Disability Index after surgery. There were significant differences between means of post-operative Visual Analogue Scale for back pain between these two groups after 1 week (3.7 in group A versus 2.2 in group B) (t = 13.28, P = < 0.001*) and after 3 months (1.73 in group A versus 0.43 in group B) (t = 10.54, P = < 0.001*). There were no significant differences between two groups regarding post-operative VAS for leg pain, recurrence (5 patients in group A versus 4 patients in group B) and reoperation rate (2 patients in each group). There were significant differences between means of length of hospital stay (2.10 in group A versus 1.06 in group B) (P < 0.001), time of returning to daily activities (7.33 in group A versus 4.03 in group B) (P < 0.001) and cost of surgery (1996.66 in group A versus 3003.3 in group B) (P < 0.001).ConclusionUse of microscope in fenestration discectomy for treatment of symptomatic lumbar disc herniation can achieve the same goals of open fenestration regarding nerve root decompression and relief of leg pain with advantage of less back pain, less hospital staying and early return to daily activities with disadvantage of more cost with the use of microscope. With 4 years follow up, there was no significant deference in rate of recurrence and reoperation with the use of microscope but we found that type of surgery for recurrent cases may be less invasive if microscope was used in primary surgery.Trial registrationNCT, NCT04112485. Registered 30 September 2019 - Retrospectively registered, https://clinicaltrials.gov/NCT04112485.

Project description:Study designSecondary analysis of data from a concurrent randomized trial and cohort study.ObjectiveThe aim of this study was to determine risks and predictors of recurrent pain following standard open discectomy for subacute/chronic symptomatic lumbar disc herniation (SLDH).Summary of background dataMost previous studies of recurrence after discectomy do not explicitly define pain resolution and recurrence, and do not account for variable durations of time at risk for recurrence.MethodsWe used survival analysis methods to examine predictors of leg pain recurrence. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of leg pain recurrence using Kaplan-Meier survival curves, and examined predictors of recurrence using Cox proportional hazards models. We used similar methods to examine LBP recurrence.ResultsOne- and three-year cumulative risks of leg pain recurrence were 20% and 45%, respectively. One- and three- year leg pain recurrence risks were substantially lower in participants with complete initial resolution of leg pain (17% and 41%, respectively) than in those without (27% and 54%, respectively). In multivariate analyses, complete leg pain resolution (adjusted hazard ratio [aHR] 0.69; 95% confidence interval [CI] 0.52-0.90), smoking (aHR 1.68 [95% CI 1.22-2.33]), and depression (aHR 1.74 [95% CI 1.18-2.56]) predicted leg pain recurrence. The 1- and 3-year risk of LBP recurrence was 29% and 65%, respectively. LBP recurrence risk at 3 years was substantially lower in participants with complete initial resolution of LBP than in those without, but not at 1 year.ConclusionRecurrence of leg pain and LBP is common after discectomy for SLDH. Cumulative risks of both leg pain and LBP recurrence were generally lower in participants achieving complete initial resolution of pain post-discectomy.Level of evidence2.

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.

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Open discectomy vs microdiscectomy for lumbar disc herniation - a protocol for a pragmatic comparative effectiveness study.

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Open discectomy vs microdiscectomy for lumbar disc herniation - a protocol for a pragmatic comparative effectiveness study.

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