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Current management guidelines for the treatment of carotid stenosis are controversial. We performed this meta-analysis to evaluate the perioperative safety of carotid artery stenting (CAS) and endarterectomy. We systematically searched EMBASE, PubMed, Web of Science, and the Cochrane Library from inception to November 10, 2022, for randomized controlled trials that compared CAS with carotid endarterectomy (CEA) among patients with carotid stenosis. The analyzed outcomes mainly included stroke, death, myocardial infarction (MI), cranial nerve palsy, the cumulative incidence of mortality, stroke, or MI and the cumulative incidence of death or stroke in the perioperative periods. The risk ratio (RR) and 95% confidence interval (95% CI) were calculated and pooled. Subgroup analyses were based on whether patients were symptomatic or asymptomatic. We assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Seventeen randomized controlled trials with 12,277 participants (6514 and 5763 in the CAS and CEA groups, respectively) were included. Pooled analysis demonstrated that compared with CEA, CAS was associated with decreased risks of perioperative MI (RR = 0.47, 95% CI = 0.29∼0.77) and perioperative cranial nerve palsy (RR = 0.02, 95% CI = 0.01∼0.06) but higher risks of perioperative stroke (RR = 1.48, 95% CI = 1.18∼1.87) and cumulative incidence of death or stroke (RR = 1.52, 95% CI = 1.20∼1.93). The perioperative safety was equivalent between CAS and CEA. However, CEA may be preferred when considering both procedural safety and long-term efficacy in preventing recurrent stroke. [ABSTRACT FROM AUTHOR]

To evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgery to achieve blood loss reduction. Sixty patients undergoing major surgery of the spine were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other group comprised patients who received oral administration of TXA 2 hours before surgery. Outcome measures included intraoperative blood loss, postoperative blood loss, hematologic parameters, blood transfusion needed, and surgical complications. Sixty patients linked up with the inclusion criteria. Intraoperative blood loss was significantly lower in the TXA oral group than in the control group; total blood loss in the TXA group was 930.66 ± 614 mL, which was lower than in the control group, with 1075.66 ± 956.11 mL. The mean reduction of hemoglobin was almost the same in both groups. Similarly, the total transfusion package received was lower, and the number of complications and length of stay were akin in both groups. A logistic regression model was performed with patients who had blood loss >1000 mL and surgery time >230 minutes. This result was related to the risk of bleeding, with an odds ratio of 1.31, 95% confidence interval, 1.004–1.023, P = 0.004, independent of the group. Oral TXA is as an effective measure for reducing total blood loss among patients undergoing elective spine surgery. [ABSTRACT FROM AUTHOR]

Several previous meta-analyses have been published, followed by additional randomized clinical trials investigating the effects of tranexamic acid (TXA) in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. As a result, the purpose of this research is to present an updated quantitative analysis of the existing literature and to further explicate its effectiveness. PubMed, Embase, Web of Science, and Cochrane Library databases were searched for randomized controlled trials (RCTs) comparing the application of TXA and placebo in patients undergoing PLIF surgery from their establishment to December 31, 2021. Data on clinical outcomes, perioperative outcomes, and complications were collected. The summary statistics for continuous and dichotomous variables were derived as weighted mean difference (WMD) and relative risk (RR), respectively. A total of 12 studies enrolling 1088 participants were included in this meta-analysis. The combined results revealed that TXA can decrease intraoperative blood loss (WMD: −84.83, P < 0.0001), total blood loss (WMD: −189.93, P < 0.00001), hidden blood loss (WMD: −134.69, P = 0.002), postoperative drainage (WMD: −100.71, P < 0.00001), postoperative hemoglobin loss (WMD: 6.21, P < 0.00001), operative time (WMD: −3.80, P = 0.007), hospital stay (WMD: −1.86, P = 0.001), and transfusion rates (RR: 0.41, P < 0.00001) in PLIF without increasing the risk of thromboembolic events (RR: 0.80, P = 0.43). TXA can considerably decrease surgical blood loss, postoperative drainage, reduce operative times, hospital stays, and transfusion rates. Furthermore, the TXA group had lower postoperative hemoglobin drop values than the placebo group. [ABSTRACT FROM AUTHOR]

The role of tranexamic acid (TXA) in controlling blood loss during spine surgery remains unclear. With the publication of new randomized controlled trials (RCTs), we conducted a meta-analysis to determine the safety and efficacy of TXA in spine surgery. PubMed, Embase, Web of Science, and Cochrane databases were searched for relevant studies through 2022. Only RCTs were eligible for this study. The extracted data were analyzed using RevMan 5.3 software for meta-analysis. Twenty RCTs including 1497 patients undergoing spine surgery were included in this systematic evaluation. Compared with the control group, TXA significantly reduced total blood loss (mean difference [MD] = – 218.96, 95% confidence interval [CI] = – 309.77 to – 128.14, P < 0.00001), perioperative blood loss (MD = – 90.54, 95% CI = – 139.33 to – 41.75, P = 0.0003), postoperative drainage (MD = – 102.60, 95% CI = – 139.51 to – 65.70, P < 0.00001)，reduced hospital stay (MD = – 1.42, 95% CI = – 2.71 to – 0.14, P = 0.03), reduced total blood transfusion volume (MD = – 551.06, 95% CI = – 755.90 to – 346.22, P < 0.00001), and international normalized ratio (MD = −0.03, 95% CI = −0.04 to −0.02, P < 0.00001). Based on the meta-analysis of 20 RCTs, we demonstrated that TXA reduces blood loss in open spine surgery, decreases transfusion rates, and shortens hospital stays. The TXA administration during the perioperative period does not increase the incidence of postoperative complications. [ABSTRACT FROM AUTHOR]

From a pathophysiological point of view, early neurosurgical treatment seems essential to prevent secondary brain injury and has been stated as the "time-is-brain" concept. However, the question immediately rises: "Is there an optimal time window for acute intracranial neurosurgical interventions?" In neurosurgery, treatment modality has been studied far more extensively than timing to surgery ("time-to-surgery"). The majority of acute intracranial neurosurgical interventions are carried out for traumatic brain injury and hemorrhagic or ischemic stroke. Current guidelines for traumatic brain injury, spontaneous intracerebral hemorrhage, aneurysmal subarachnoid hemorrhage, and middle cerebral artery infarction are reviewed and lessons learned from the randomized controlled trials mentioned are discussed. In acute intracranial neurosurgical interventions, "delayed consent" procedures could play an important role for this field of research. Whether there is an optimal time window for acute intracranial neurosurgical interventions seems difficult to be answered with randomized controlled trials referred to in the current guidelines. Observational designs, such as comparative effectiveness research, and special statistical techniques, may provide a better understanding in the optimal "time-to-surgery." [ABSTRACT FROM AUTHOR]

Clinical trials are performed to determine the safety, efficacy, or effectiveness of a medical or surgical intervention. A clinical trial is, by definition, prospective in nature with a uniform treatment of a defined patient cohort. The outcomes assessment should also be uniform. Often a control group is included. At present, the number of neurosurgical clinical trials is increasing, and the study designs have become more sophisticated. Historically, the standard of neurosurgical care has evolved from the findings from many case series and retrospective comparative studies. However, in the present report, we have focused exclusively on prospective clinical trials. An urgent need exists to understand how clinical trials have been performed in the past and how they can be improved to advance our neurosurgical practice. In the present review, we have discussed the barriers, successes, and failures regarding prospective clinical trials in neurosurgery with an outlook to the future. [ABSTRACT FROM AUTHOR]

The UK neurosurgical community has a track record of delivering high-quality, practice-changing clinical research studies, facilitated by a robust clinical research infrastructure and close collaborations between neurosurgical centers. More recently, these large-scale studies have been conceived, developed, and delivered by neurosurgical trainees, working under the umbrella of the British Neurosurgical Trainee Research Collaborative (BNTRC). In this paper, we outline the current landscape of large-scale neurosurgical studies in the UK, focusing on the role of trainees in facilitating this research. Importantly, we focus on our experience of trainee-led studies, including the development of the network, current challenges, and future directions. We believe that a similar model can be applied in different settings and countries, which will drive up the quality of neurosurgical research, ultimately benefiting future neurosurgical patients. [ABSTRACT FROM AUTHOR]

Classic randomized controlled trials (RCTs) form the cornerstone for medical guidelines and protocols. However, in neurosurgery, RCTs are not always applicable to everyday clinical practice. Pragmatic controlled trials aim to incorporate real-life data with the preservation of the methodologic quality. This study is a systematic literature review of all pediatric neurosurgical RCTs published between 2000 and 2020 and an analysis of their pragmatism. An electronic database search was performed in PubMed, EMBASE, and the Cochrane Library to identify all relevant trials. Pragmatism was evaluated retrospectively on 9 domains: eligibility, recruitment, setting, organization, flexibility (delivery and adherence), follow-up, primary outcome, and primary analysis. Of the 1862 studies included, 15 met the inclusion criteria. On average, studies scored between equally pragmatic/explanatory and rather pragmatic (M = 3.59, standard deviation [SD] = 0.56). Lowest ratings were seen for setting (M = 2.80, SD = 1.66) and eligibility (M = 3.20, SD = 1.66). Highest scores of pragmatism were given to analysis (M = 4.67, SD = 0.82) and intervention organization (M = 4.60, SD = 1.06). There was no significant difference between studies based on number of patients included, main subject, or publication year. Pediatric neurosurgical RCTs scored reasonably well on overall pragmatism. In the future, there will be a greater need for pragmatic controlled trials in pediatric neurosurgery to bridge the divide between real-life data and reliable methodological quality. There is an opportunity to develop further applications of pragmatism tailored to surgical interventions. [ABSTRACT FROM AUTHOR]

The ventricular system is a set of brain cavities without solid tissues and the basis of surgical brain anatomy. To the best of our knowledge, the effect of using 3-dimensional (3D) printed models (3DPMs) on anatomy education of the ventricular system has not been reported. We established 3DPMs for the ventricular system and performed a randomized controlled study to evaluate the educational effect of 3DPMs, 3D images (3DIs), and 2-dimensional images (2DIs). We randomly divided 60 second-year medical students into 3 groups, with 3DPMs, 3DIs, and 2DIs used as teaching aids, 1 for each group. Before and after the anatomy class on the features of ventricular system, all students completed the same test. No statistical significant differences were detected between the mean values of the pretest scores of the 3 groups (P > 0.05). For the post-test scores, the students in the 3DPM and 3DI groups performed significantly better than those in the 2DI group in terms of the practice test score (3DPM group vs. 2DI group, P < 0.001; 3DPM group vs. 2DI group, P = 0.009) and total score (3DPM group vs. 2DI group, P = 0.001; 3DI group vs. 2DI group, P = 0.025). From the students' evaluation results, the 3DPM group performed better than the 3DI group for "enjoyment" and "attitude" (P = 0.039 and P = 0.025, respectively). Compared with 2DIs, use of 3DPMs and 3DIs could improve the effectiveness of teaching the anatomy of the complex ventricular system. In addition, 3DPMs could markedly increase the interest and enthusiasm of students. [ABSTRACT FROM AUTHOR]

Objective Randomized allocation of treatment options is not well accepted within the clinical community. Some methods of implementation may be received more favorably than others. Prerandomization may be an acceptable means to facilitate recruitment in some clinical trials. Methods We first compare randomization and prerandomization using illustrative neurovascular trials. We review some problems with conventional trials, Zelen's prerandomization as an alternative method, and the ethical issues that have surrounded prerandomization since its inception in a historic trial. Conventional and Zelen's randomization are then compared with other means to provide and verify care in the context of clinical uncertainty. Results The major problem with conventional randomization is that consent is requested for 2 management options, one of which the patient will not receive. The problem with prerandomization is that treatment is allocated before the patient has consented to trial participation. Prerandomization may trade recruitment difficulties for excessive crossovers. However, other ways to practice under uncertainty and verify patient outcomes, such as case series and registries, are more ethically and scientifically problematic. Conclusions Until the ethical functions of randomized allocation of selected treatment options in the care of patients are recognized by the neurovascular community, Zelen's prerandomization may help recruitment into difficult trials and contribute a means to provide best possible care in the presence of uncertainty. [ABSTRACT FROM AUTHOR]

In the United States, chronic low back pain affects up to 37% of adults and is a multibillion dollar health care expenditure. Spinal cord simulation (SCS) has been established as an effective treatment alternative for chronic neuropathic low back and leg pain, especially for patients with failed back surgery syndrome or chronic regional pain syndrome. The field of SCS has rapidly advanced such that analgesia can now be achieved through numerous different waveforms, each claiming to offer improved outcomes. These waveforms include traditional paresthesia-based SCS (<100 Hz), paresthesia-free high-frequency SCS (5–10 kHz), burst SCS, and subperception SCS (1–5 kHz). Level 1 evidence critically evaluating the efficacy of these different waveforms is lacking. We conducted a systematic review of the literature in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify all randomized controlled trials of SCS in the treatment of chronic neuropathic low back and leg pain, failed back surgery syndrome, or chronic regional pain syndrome. Of 38 eligible studies reviewed, 13 randomized controlled trials were finally included in our systematic review. We reviewed evidence from randomized controlled trials in the field of SCS that have established paresthesia-based SCS, paresthesia-free high-frequency SCS, burst SCS, and subperception SCS as viable treatment options for chronic neuropathic low back and leg pain. We critically evaluated evidence that claims to support the use of one waveform over another and reviewed the literature on patient preference for different waveforms. [ABSTRACT FROM AUTHOR]

Objective To determine whether opioids during the first 24 postoperative hours were significantly altered when receiving intravenous (IV) acetaminophen during that time compared with those receiving placebo (normal saline). Methods One hundred forty patients undergoing any type of craniotomy were randomly assigned to receive either 1 g of IV acetaminophen or placebo upon surgical closure, and every 6 hours thereafter, up to 18 hours postoperatively. Analgesic requirements for the first 24 postoperative hours were recorded. Time to rescue medications in the postanesthesia care unit (PACU)/intensive care unit (ICU), amount of rescue medication, ICU and hospital lengths of stay, number of successful neurological examinations, sedation, delirium, satisfaction, and visual analog scale pain scores were also recorded. Results Compared with the placebo group, more patients in the IV acetaminophen group (10/66 [15.2%] vs. 4/65 [6.2%] in the placebo group) did not require opioids within the first 24 postoperative hours, but this did not reach significance (odds ratio, −9.0%, 95% confidence interval −20.5% to 1.8%; P = 0.166). Both groups had similar times to rescue medications, amounts of rescue medications, ICU and hospital lengths of stay, numbers of successful neurological examinations, sedation, delirium, satisfaction scores, visual analog scale pain scores, and temperatures within the first 24 postoperative hours. Conclusions The opioid requirements within the first 24 postoperative hours were similar in the placebo and acetaminophen groups. This study is informative for the design and planning of future studies investigating the management of postoperative pain in patients undergoing craniotomies. [ABSTRACT FROM AUTHOR]