Objective
The COVID-19 pandemic has considerably impacted surgical practice. The present study aimed to investigate the effects of the pandemic on neurosurgical practice and the safety of the resumption of elective procedures through implementing screening protocols in a high-volume academic public center in Iran as one of the countries severely affected by the pandemic.
Methods
This unmatched case-control study compared two populations of patients who underwent neurosurgical procedures between June 1, 2019- September 1, 2019, and the same period in 2020. In the prospective part of the study, patients who underwent elective procedures were tested for SARS-CoV-2 infection postoperatively to evaluate the viability of our screening protocol.
Results
Elective and emergency procedures showed significant reduction (59.4%, n=168 vs 71.3%, n=380) and increase (28.7%, n=153 vs 40.6%, n=115) in their percentages during the pandemic period, respectively (p=0.003). The proportional distribution of neurosurgical categories remained unchanged during the pandemic period. Poisson regression showed that the reduction in total daily admissions and some categories, including spine, trauma, oncology, and infection were significantly correlated with the pandemic period. Among patients who underwent elective procedures, 0 (0.0%) and 26 (16.25%) had positive test results on day-30 and 60 postoperatively, respectively. Overall mortality rates were comparable between the pre-COVID-19 and COVID-19 periods, yet patients with concurrent SARS-CoV-2 infection showed substantially higher mortality rates (65%).
Conclusion
By implementing safety and screening protocols with proper resource allocation, we can maintain the emergency care capacity while minimizing the risk of hospital-acquired SARS-CoV-2 infection, complications, and mortality among neurosurgical patients during the pandemic period. Similarly, for elective procedures, according to available resources, we can allocate hospital beds for patients with a higher risk of delayed hospitalization and reassure those who are concerned about the risk of hospital-acquired infection.
Objectives: Vitamin D plays a major role in bone metabolism, regulating calcium and phosphorus homeostasis, along with bone growth and remodeling processes. The objective of the present study was to assess the effect of vitamin D deficiency on clinical outcomes following elective spinal fusion surgery by conducting a meta-analysis on the relevant literature.Methods: Studies included in this analysis involved patients older than 18 years who underwent elective spinal fusion surgery. The number of patients as well as visual analog scale (VAS) and Oswestry Disability Index (ODI) in groups with and without vitamin D deficiency were required to be reported in eligible studies. Of the 179 articles identified, 7 met the inclusion criteria and were included in the analysis.Results: Seven studies, including 1188 patients, reported the relationship between vitamin D deficiency and clinical outcomes in patients undergoing elective spinal fusion surgery. Five studies reported VAS as a primary outcome. The combined results using a random-effects model showed reduction in VAS after elective spinal fusion surgery in group with vitamin D deficiency, but no statistically significant association was identified between vitamin D deficiency and VAS. ODI was assessed and reported as an outcome measure in 5 of the included studies. The combined results showed an increase in ODI following elective spinal fusion surgery in the vitamin D-deficient group compared to the group with normal levels of vitamin D. In addition, a significant association was observed between ODI and vitamin D deficiency.Conclusions: Vitamin D deficiency may negatively affect the postoperative outcomes in elective spinal fusion surgery. Preoperative optimization of vitamin D levels would seem appropriate. Future high-quality studies are highly warranted to evaluate this.Clinical Relevance: This meta-analysis demonstrated a significant association between vitamin D deficiency and postoperative ODI scores in patients undergoing elective spinal fusion surgery.
Background
Glioblastoma multiforme (GBM) is associated with remarkably poor prognosis, and its treatment is challenging. This investigation aimed to evaluate the safety of suicide gene therapy using allogeneic adipose tissue-derived mesenchymal stem cells (ADSCs) carrying herpes simplex virus-thymidine kinase (HSV-TK) gene for the first time in patients with recurrent GBM.
Methods
This study was a first-in-human, open-label, single-arm, phase I clinical trial with a classic 3 + 3 dose escalation design. Patients who did not undergo surgery for their recurrence were included and received this gene therapy protocol. Patients received the intratumoral stereotactic injection of ADSCs according to the assigned dose followed by prodrug administration for 14 days. The first dosing cohort (n = 3) received 2.5 × 105 ADSCs; the second dosing cohort (n = 3) received 5 × 105 ADSCs; the third dosing cohort (n = 6) received 10 × 105 ADSCs. The primary outcome measure was the safety profile of the intervention.
Results
A total of 12 patients with recurrent GBM were recruited. The median follow-up was 16 (IQR, 14-18.5) months. This gene therapy protocol was safe and well tolerated. During the study period, eleven (91.7%) patients showed tumor progression, and nine (75.0%) died. The median overall survival (OS) was 16.0 months (95% CI 14.3–17.7) and the median progression-free survival (PFS) was 11.0 months (95% CI 8.3–13.7). A total of 8 and 4 patients showed partial response and stable disease, respectively. Moreover, significant changes were observed in volumetric analysis, peripheral blood cell counts, and cytokine profile.
Conclusions
The present clinical trial, for the first time, showed that suicide gene therapy using allogeneic ADSCs carrying the HSV-TK gene is safe in patients with recurrent GBM. Future phase II/III clinical trials with multiple arms are warranted to validate our findings and further investigate the efficacy of this protocol compared with standard therapy alone.
Trial registration: Iranian Registry of Clinical Trials (IRCT), IRCT20200502047277N2. Registered 8 October 2020, https://www.irct.ir/.
OBJECTIVE
Prior evidence has supported the use of local intraoperative epidural steroids in lumbar discectomy for improvements in postoperative pain and outcomes. However, currently there is a paucity of data regarding the efficacy of local epidural steroids in spinal fusion procedures. The present investigation aimed to evaluate the impact of local epidural administration of triamcinolone acetonide–soaked Gelfoam on postoperative pain and patient-reported outcomes in patients undergoing instrumented posterolateral lumbar spinal fusion.
METHODS
In this randomized, double-blind, placebo-controlled trial, patients were randomly divided into two groups (treatment and control). Patients in the treatment group received a Gelfoam carrier soaked in 1 ml of triamcinolone acetonide (40 mg), which was placed over the nerve roots in the epidural space before the closure. Patients in the control group received a Gelfoam carrier soaked in normal saline in a similar fashion to the treatment group. Patients were followed up during their hospital stay and at 4 and 12 weeks postoperatively. The primary outcome measure was early postoperative visual analog scale (VAS) scores for pain both at rest and with movement.
RESULTS
A total of 100 patients were recruited in this study and were randomly allocated to the treatment or control group. No significant difference was found in baseline demographic, clinical, and surgical characteristics between the two groups. Postoperative VAS scores for pain both at rest and with movement were comparable between the treatment and control groups. Cumulative morphine consumption, length of hospital stay, and incidence of postoperative complications such as surgical site infection were also similar between the two groups. There was no significant difference in patient-reported outcomes including VAS scores for back and leg pain as well as the Oswestry Disability Index at 4 and 12 weeks postoperatively. The proportion of patients who achieved a minimum clinically important difference for patient-reported outcomes were also similar between the two groups.
CONCLUSIONS
In contrast to the existing literature on the beneficial use of local intraoperative epidural steroids in conventional lumbar discectomy, the present study did not demonstrate such significant efficacy for the use of local epidural steroids in instrumented posterolateral lumbar spinal fusion. However, there is still a lack of evidence in this regard and further high-quality clinical trials are required to evaluate the efficacy of local epidural steroids in this group of patients.
Background: Multimodal perioperative pain management including nonopioid analgesia is a major pillar of enhanced recovery after surgery programs. The aim of this study was to investigate the analgesic efficacy of the preoperative combination of 2 nonopioid drugs, oral pregabalin and intravenous magnesium sulfate, in patients undergoing posterolateral lumbar spinal fusion.Methods: This 4-arm, randomized, double-blind, placebo-controlled trial included 104 patients randomly allocated to receive: magnesium sulfate and pregabalin (MP), magnesium sulfate and oral placebo (M), 0.9% saline and oral pregabalin (P), and 0.9% saline and oral placebo (C). The study drugs were administered 1 hour preoperatively. The primary outcome was the cumulative morphine consumption on postoperative day 1. Secondary outcomes included visual analog scale scores for leg pain at rest and with movement, and postoperative nausea and vomiting (PONV) in the first 48 hours after surgery.Results: Cumulative morphine consumption on postoperative day 1 was lower in group MP (19.6 ± 8.0 mg) compared with group M (32.6 ± 9.5 mg; P < 0.001), group P (28.9 ± 9.4 mg; P = 0.001), or group C (38.8 ± 10.3 mg; P < 0.001). Multiple linear regression demonstrated a significant association between group MP and cumulative morphine consumption (B = −5.4 [95% CI, −7.1, −3.7], P < 0.001). Visual analog scale scores for leg pain at rest and with movement were lower in group MP compared with other groups (P = 0.006 and <0.001). The incidence of PONV was also lowest in group MP (P = 0.032).Conclusions: Preoperative administration of oral pregabalin and intravenous magnesium sulfate resulted in reduced morphine consumption and greater analgesic effect than the use of each drug individually or placebo in patients undergoing posterolateral lumbar spinal fusion.
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