Prospective Nonrandomized Study Research Articles

Prognostic role of serum copeptin levels in adults with graded traumatic brain injury.

The efficacy of copeptin in patients with severe head injuries remains unclear. To investigate the role of serum copeptin levels in detecting intracranial injury, assessing trauma severity, and predicting outcomes in adults with graded traumatic brain injury (TBI). This prospective non-randomized controlled study enrolled 78 adults with isolated head trauma, as well as 59 age- and sex-matched controls. Baseline serum copeptin levels were measured in both groups. Patients were categorized by head trauma severity using Glasgow Coma Scale (GCS) scores (severe GCS 3-8, moderate GCS 9-13, mild GCS 14-15) and by the presence of intracerebral or extracerebral lesions on cranial computed tomography (CCT). Patients were also classified as survivors or non-survivors. Serum copeptin levels were compared among these. Mean serum copeptin levels were significantly higher in patients with graded TBI than in controls. Furthermore, patients with severe and moderate head trauma had significantly higher copeptin levels compared with patients exhibiting mild trauma. An optimal copeptin cutoff value of > 1147pg/mL was identified, indicating the presence of moderate or severe trauma in TBI patients. Patients with abnormal CCT findings had significantly higher mean serum copeptin levels compared with patients exhibiting normal CCT scans. Non-survivors also showed significantly higher serum copeptin levels compared with survivors. Serum copeptin levels rise after graded TBI and can distinguish between patients with and without intracranial or extracranial lesions evident on CCT. Copeptin levels also aid in identifying moderate or severe TBI and in predicting 28-day mortality.

The Effectiveness of Letrozole Alone or in Combination with Methotrexate in the Management of Ectopic Pregnancy, A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to investigate the effect of letrozole alone or in combination with Methotrexate on the management of ectopic pregnancy. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were applied for reporting. The EMBASE, PubMed, Scopus, and Web of Science databases were searched for relevant studies focused on women diagnosed with ectopic pregnancy and managed non-surgically with letrozole alone or in combination with methotrexate (MTX) until April 2024. The success rate, laboratory findings, and complications were analyzed and reported. Meta-analysis was done using RevMan 5.4.1 software. Out of 129 unique studies obtained, 7 of them were found eligible for final review; of which, 3 were nonrandomized prospective cohort studies, 2 were randomized clinical trials, and 2 study were case studies. In 5 studies letrozole was used as monotherapy. While in another study letrozole was used with MTX. The meta-analysis showed a significantly lower level of β-HCG in the letrozole group compared to MTX, 7days after initiation of treatment (Fixed effect model, MD = -92.22, 95%CI: [-159.39, -25.04], P = 0.007, I2 = 0%). There was no significant difference in the level of anti-mullerian hormone (AMH) between groups (Fixed effect model, MD = 0.18, 95%CI: [-0.09, 0.45], P = 0.20, I2 = 0%). Success rate, platelet count, and level of liver enzymes seemed to be better or similar among patients receiving Letrozole compared to patients receiving Methotrexate. Letrozole exhibits potential as a therapeutic option for ectopic pregnancies; however, further randomized clinical trials are necessary to establish strong evidence.

Detection of atrial fibrillation after stroke due to large or small vessel disease: systematic review and meta-analysis.

Emerging evidence indicates a frequent occurrence of atrial fibrillation (AF) detection among patients with established causes of ischemic stroke unrelated to AF. This systematic review and meta-analysis aimed to evaluate AF detection rates in stroke patients with large or small vessel disease, considering the AF detection modality and duration of cardiac rhythm monitoring. We conducted a comprehensive search of PubMed and Scopus databases up to March 2, 2024, to identify randomized controlled trials, non-randomized prospective studies, and retrospective studies assessing the frequency of AF detection in stroke patients with large or small vessel disease. The primary outcome of interest was the rate of AF detection. We utilized inverse-variance weights to produce the pooled prevalence (effect size-ES) and 95% confidence interval (CI) of patients diagnosed with post-stroke AF. In the analysis of 14 eligible studies encompassing 4,334 patients, AF was identified in 154 out of 2,082 patients with strokes attributed to small or large-vessel disease, yielding a pooled prevalence of 6.27% (ES; 95% confidence interval [CI]: 3.18-10.17, I2=87.83%). Among patients with large-vessel disease strokes, AF was diagnosed in 79 out of 1,042 patients, accounting for a pooled prevalence of 5.07% (ES;95% CI: 1.30-10.33, I2=77.05%). Similarly, among those with small-vessel disease strokes, AF was detected in 75 out of 1,040 patients, with a pooled prevalence of 5.03% (ES; 95% CI: 1.96-9.06, I2=78.05%). AF is often found in ischemic stroke patients with large or small-vessel disease. Detection rates increase with longer cardiac rhythm monitoring. The safety and benefits of oral anticoagulation for these AF episodes are uncertain.

Comparative analysis of methods of surgical correction of post-hysterectomy pelvic organ prolapse

BACKGROUND: The incidence of prolapse after hysterectomy requiring surgical intervention is estimated at 36 cases per 10,000 women. A universal surgical treatment method for post-hysterectomy pelvic organ prolapse is lacking, prompting the need for new approaches. AIM: To comparatively analyze the results of laparoscopic sacrocolpopexy, sacrospinous fixation, and the developed new method of surgical correction of pelvic organ prolapse after hysterectomy. MATERIAL AND METHODS: This prospective non-randomized study included 57 patients with stage II, III, or IV symptomatic post-hysterectomy prolapse of the pelvic organs who were admitted at the clinical hospital RZD-Medicine in Tula, Russia, between August 2019 and September 2023. The first group (n=18) consisted of women who underwent surgical correction of post-hysterectomy pelvic organ prolapse in a newly developed method; the second group (n=19) included women who underwent laparoscopic promontofixation according to the conventional technique; and the third group (n=20) involved patients who underwent installation of an apical sling using a UroSling-1 mesh endoprosthesis (Lintex LLC, St. Petersburg). The patients’ quality of life was assessed using specialized validated questionnaires: Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Patients were asked to complete questionnaires before surgery and 12 and 24 months after surgical correction of PGP. The patients were invited for a follow-up examination after 1, 6, 12, and 24 months. RESULTS: The duration of the operation in the second group significantly exceeded the indicators of the first and third groups. The average duration of hospital stay of patients was 4.4±0.6 (95% CI: 4.1–4.7) bed days in the first group, 4.9±1.1 (95% CI: 4.6–5.3) in the second, and 4.6±0.6 (95% CI: 4.3–4.9) in the third. The differences were insignificant (p1–2=0.437; p1–3=0.137; p2–3=0.235). The anatomical results after 24 months at points Aa and Ba showed significant differences. At point Aa, p1–3=0.007 and p2–3=0.004, and at point Ba, p1–3=0.032 and p2–3=0.041. A comparative assessment of the questionnaire data before surgery and 12 and 24 months after surgery showed a significant improvement in the quality of life of patients in the three groups. CONCLUSION: The proposed method of correction of post-hysterectomy pelvic organ prolapse provides high anatomical and functional results and reduces the posibility of repeated surgical intervention for recurrence.

Interval breast cancer rates for tomosynthesis vs mammography population screening: a systematic review and meta-analysis of prospective studies.

We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening. We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects. Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: -2.92 per 10,000 screens (95% CI: -6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: -9.47 to -1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ. This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM. Question Does DBT have long-term benefits over standard DM? Finding We find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers. Clinical relevance This meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis.

Indocyanine green and methylene blue dye guided sentinel lymph node biopsy in patients with penile cancer (PeCa): results of 50 inguinal basins assessed at a single institution in India.

The primary aim of this study was to validate the reliability, sensitivity and safety profile of novel combination of ICG- methylene blue dye as an SN tracer for PeCa. This is a validation and non-randomised prospective observational study involving 25 patients (50 inguinal basins) who underwent SLNB where in ICG and methylene blue were used for localisation. The patients with clinically node negative groins were recruited in the study. SNs were identified intraoperatively using near infrared fluorescence imaging (NIRF Imaging system, SPY-PHI, Stryker, Sweden) and blue dye. The numbers of SNs identified by each tracer and the rates of complications and nodal recurrence during the followup. Overall 137 SNs were identified intraoperatively. Among the 137 SNs excised fluorescence, blue dye and Combined (blue + green) identified 57(41.6%), 27 (19.7%), and 51 (37.2%), respectively. The average number of SLNs removed per patient was 5 (range, 1-11) with sentinel lymph nodes detection rate at 94% (47/50). Seven patients had malignancy on SLNB and underwent ipsilateral radical inguinal lymphadenectomy. One patient had false negative SN and positive node in modified inguinal lymphadenectomy specimen. No adverse events were observed in all cases. The Novel combination of ICG fluorescence-Methylene blue dye technique is simple, reliable and safe. Moreover, it demonstrates a high SLN detection rate with a low false-negative rate, and it avoids radiation exposure.

Physiotherapy-led care versus physician-led care for persons with low back pain: A systematic review.

To summarise the evidence on the effect of physiotherapy-led versus physician-led care on clinical outcomes, healthcare use, and costs in persons with low back pain. PubMed, Web of Science, CINAHL, Embase, and PEDro were systematically searched with the latest search performed in July 2024. Reference lists of articles were hand-searched. Studies comparing clinical outcomes, healthcare use, or costs between adults with low back pain first consulting a physiotherapist and those first consulting a physician were included. Methodological quality was assessed with the Newcastle-Ottawa Scale. Study design, clinical setting, patient characteristics, and group effects were extracted. Findings on outcomes assessed in two or more studies were synthesised narratively. Certainty of evidence was determined using the GRADE approach. Eighteen studies comprising 1,481,980 persons with low back pain were included. Most studies were non-randomised retrospective or prospective cohort studies. In primary care (15 studies), consistent evidence, though of mostly very low certainty, indicated that physiotherapy-led care leads to higher patient satisfaction, less use of medication, injections and imaging, fewer physician's visits, lower total healthcare costs, and less sick leave compared to physician-led care, without increased harm. In emergency care (three studies), evidence of very low certainty showed that physiotherapy-led care leads to shorter waiting and treatment times, and fewer hospital admissions. Physiotherapy-led care is a clinically, time- and cost-effective care pathway for low back pain, although the certainty of evidence was overall very low. Further high-quality research with a greater focus on clinical outcomes is warranted.

Covering corneal stromal lenticule for macular hole in pathological myopia.

To evaluate the clinical effect of a new surgery technique (covering corneal stromal lenticule, CSL) for macular hole (MH) in pathological myopia. This was a prospective non-randomized series case study. Fourteen eyes of 14 patients whose axial length were more than 29 mm and suffered from MH and macular hole retinal detachment (MHRD) were included in this study. All cases were treated with 25-gauge pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling, covering CSL and C3F8 gas tamponade. These cases were followed for 6mo, and the best-corrected visual acuity (BCVA), healing status of MH, the reattached rate of retinal detachment (RD), and reoperation rate were analyzed. All cases were successfully performed the surgery and the postoperative follow-up was completed. After surgery, MHs were healed in all 14 eyes (100%, 14/14) after assessed by optical coherence tomography. The reattachment of retina was achieved in all 6 eyes (100%, 6/6) with MHRD. BCVA was improved in 12 eyes (85.71%, 12/14), and had no significant change in 2 eyes (14.29%, 2/14). The overall mean BCVA was improved from 1.80±0.77 to 0.82±0.46 logMAR (F=10.46, P<0.01). No serious complications occurred in all cases. The new surgery technique (covering CSL) has high reattached rate of RD and high healing rate of MH in pathological myopia in the preliminary study. And it can effectively improve the visual function of patients. This new technique offers meaningful new ideas for treating refractory MH in pathological myopia.

Effectiveness of bracing combined with exercise-based treatment of adolescent idiopathic scoliosis: Assessing the synergistic benefits: A systematic review

The purpose of this study was to evaluate evidence on the effectiveness of combined bracing and exercise on adolescent idiopathic scoliosis (AIS). From inception to April 28, 2022, PubMed and Web of Science searched for randomized clinical and nonrandomized prospective studies reporting Cobb angle (CA), angle of trunk rotation (ATR), quality of life (QoL), and pulmonary function (PF) in AIS patients treated with exercise and braces (10 years-skeletal maturity). Two authors analyzed and extracted data for this review. The PEDro scale was used to assess the risk of bias (RoB). Therapy protocols and basic data have been collected. Each CA, ATR, QoL, and PF study’s evidence and strength were also included. A total of 12 studies with 714 patients with AIS were included. Five studies used a control group with exercises and 7 with braces. The results showed that exercise-brace can decrease CA and ATR and increase QoL and PF with AIS; however, the strength of conclusion for all outcomes was moderate. In this review, 4 studies were categorized as low RoB, 3 as moderate RoB, and 5 as high RoB. Level of evidence analysis revealed that 12 studies were classified as level of evidence B. The current studies do not sufficiently support the effects of exercise and brace therapy on CA, ATR, QoL, and PF in patients with AIS.

Cost-effectiveness of proton beam therapy vs. conventional radiotherapy for patients with brain tumors in Sweden: results from a non-randomized prospective multicenter study

BackgroundThis study assessed the cost-effectiveness of proton beam therapy (PBT) compared to conventional radiotherapy (CRT) for treating patients with brain tumors in Sweden.MethodsData from a longitudinal non-randomized study performed between 2015 and 2020 was used, and included adult patients with brain tumors, followed during treatment and through a one-year follow-up. Clinical and demographic data were sourced from the longitudinal study and linked to Swedish national registers to get information on healthcare resource use. A cost-utility framework was used to evaluate the cost-effectiveness of PBT vs. CRT. Patients in PBT group (n = 310) were matched with patients in CRT group (n = 40) on relevant observables using propensity score matching with replacement. Costs were estimated from a healthcare perspective and included costs related to inpatient and specialized outpatient care, and prescribed medications. The health outcome was quality-adjusted life-years (QALYs), derived from the EORTC-QLQ-C30. Generalized linear models (GLM) and two-part models were used to estimate differences in costs and QALYs.ResultsPBT yielded higher total costs, 14,639 US$, than CRT, 13,308 US$, with a difference of 1,372 US$ (95% CI, -4,914–7,659) over a 58 weeks’ time horizon. Further, PBT resulted in non-significantly lower QALYs, 0.746 compared to CRT, 0.774, with a difference of -0.049 (95% CI, -0.195–0.097). The probability of PBT being cost-effective was < 30% at any willingness to pay.ConclusionsThese results suggest that PBT cannot be considered a cost-effective treatment for brain tumours, compared to CRT.Trial registrationNot applicable.

Assessment of fluid responsiveness after tidal volume challenge in renal transplant recipients: a nonrandomized prospective interventional study.

When applying lung-protective ventilation, fluid responsiveness cannot be predicted by pulse pressure variation (PPV) or stroke volume variation (SVV). Functional hemodynamic testing may help address this limitation. This study examined whether changes in dynamic indices such as PPV and SVV, induced by tidal volume challenge (TVC), can reliably predict fluid responsiveness in patients undergoing renal transplantation who receive lung-protective ventilation. This nonrandomized interventional study included renal transplant recipients with end-stage renal disease. Patients received ventilation with a 6 mL/kg tidal volume (TV), and the FloTrac system was attached for continuous hemodynamic monitoring. Participants were classified as responders or nonresponders based on whether fluid challenge increased the stroke volume index by more than 10%. The analysis included 36 patients, of whom 19 (52.8%) were responders and 17 (47.2%) were nonresponders. Among responders, the mean ΔPPV6-8 (calculated as PPV at a TV of 8 mL/kg predicted body weight [PBW] minus that at 6 mL/kg PBW) was 3.32±0.75 and ΔSVV6-8 was 2.58±0.77, compared to 0.82±0.53 and 0.70±0.92 for nonresponders, respectively. ΔPPV6-8 exhibited an area under the curve (AUC) of 0.97 (95% confidence interval [CI], 0.93-1.00; P≤0.001), with an optimal cutoff value of 1.5, sensitivity of 94.7%, and specificity of 94.1%. ΔSVV6-8 displayed an AUC of 0.93 (95% CI, 0.84-1.00; P≤0.001) at the same cutoff value of 1.5, with a sensitivity of 94.7% and a specificity of 76.5%. TVC-induced changes in PPV and SVV are predictive of fluid responsiveness in renal transplant recipients who receive intraoperative lung-protective ventilation.

Patient-reported outcome measures in studies on hallux valgus surgery: what should be assessed.

In recent years, there has been an increasing demand for patient-reported outcome measures (PROMs) to assess the outcome following orthopedic surgery. But, we are lacking a standard set of PROMs to assess the outcome ofhallux valgus surgery. The aim of this study was to analyze the chosen patient rated outcome scores used in studies reporting on hallux valgus surgery. The study was based on a previously published living systematic review. Included were prospective,comparative studies of different surgical procedures or the same procedure for different degrees of deformity. Four common databases were searched for the last decade. Study selection, data extraction, and risk of bias assessment were made by two independent reviewers. Data assessed were the individual PROMs used to assess the outcome of hallux valgus surgery. 46 studies (30 RCTs and 16 non-randomized prospective studies) met the inclusion criteria. The most commonly used clinical outcome measures were the AOFAS (55%) and the VAS (30%). No differences were found between frequency of the individual scores per the level of evidence or the type of osteotomy. Based on a systematic literature review, the AOFAS and VAS are the most frequently used outcome tools in studies assessing the outcome following hallux valgus surgery. Based on the literature available, the MOXFQ is a more valid alternative. Level I; systematic review of prospective comparative (level II) and randomized controlled trials (level I).

The use of air abrasion method to treat caries in autistic patients at the age of 6 years: A non-randomized controlled trial.

Autism Spectrum Disorders (ASD) encompass a range of conditions characterized by difficulties in social interaction and communication. Managing dental treatment for children with autism presents challenges due to their reluctance to interact with dentists, which can be as high as 65%. This prospective non-randomized study, conducted at the Kazakh-Russian Medical University from January 15, 2023, to June 20, 2023, aimed to assess the efficacy of air abrasion caries treatment (AAbCT) compared to the standard method. The intervention involved applying air abrasion (AAb) treatment without anesthesia using aluminum oxide powder in the AAbCT group, while the control group received cavity preparation with local anesthesia. In this study, it was noted that the AAb method of tooth preparation was not different in efficacy from the traditional method for a population of children with autism, and could be used without anesthesia. A greater willingness to cooperate was noted (p=.0372). The AAb is an effective and safe treatment for children with ASD. Further studies needed to investigate its efficacy and safety in combination with behavioral interventions.

Intravenous lidocaine for refractory pain in patients with pancreatic ductal adenocarcinoma and chronic pancreatitis (LIDOPAN): a multicenter prospective non-randomized pilot study.

Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. Multicentre prospective non-randomized pilot study including patients with moderate or severe pain (NRS ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5mg/kg, was followed by continuous infusion at 1.5 mg/kg/hour. The dose was raised every 15 minutes until treatment response (up to a maximum 2mg/kg/hour) and consecutively administered for two hours. Primary outcome was the mean difference in pain severity, pre-infusion and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥ 1.3 points was considered clinically relevant. Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day one was 1.1 (SD±1.3) points for patients with PDAC and 0.5 (SD±1.7) for CP patients. A clinically relevant decrease in BPI on day one was reported in 9/29 patients (31%), this response lasted up to one month. No serious complications were reported, and only three minor complications (vertigo, nausea, tingling of mouth). Treatment with lidocaine did not impact quality of life. Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group, and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.

Original Moxonidine and Generics: Where is the Edge of Difference?

To compare the efficacy of adding original moxonidine and its generics to previous ineffective antihypertensive therapy in patients with poorly controlled arterial hypertension (AH). This observational prospective non-randomized study included 120 patients with poorly controlled blood pressure on the previous antihypertensive therapy. All patients underwent clinical evaluation, including anthropometric and laboratory indexes, and 24-hour blood pressure monitoring (24-h BPM) at baseline and after 12 weeks of observation. Office systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) were recorded after 4 and 12 weeks of treatment. During the observation period, 4 equal groups were formed: group 1, Physiotens was added to the treatment; group 2, Moxonitex; group 3, Moxonidine SZ; and group 4, Moxonidine Canon. Statistical analysis was performed with the StatTech v.4.2.7 software (© OOO StatTech, Russia). After 4 weeks of therapy, the BP target was achieved significantly more frequently in group 1 (63% of patients) compared to groups 2 (36.7% of patients), 3 (16.7% of patients), and 4 (16.7% of patients) (p&lt;0.05). At 12 weeks, office SBP, DBP, and HR were significantly decreased in all groups, but the decrease was significantly greater in group 1. The therapy was associated with a more pronounced decrease in all studied 24-h BPM parameters in the Physiotens group than in other groups, as well as with a significantly more frequent normalization of the 24-h BP profile, in 66.7% of patients vs. 46.7%, 33.4%, and 23.2% of patients in groups 2, 3, and 4, respectively. The treatment with original moxonidine demonstrated advantages over generic drugs in terms of achieving the BP goal, reducing office BP and HR, and improving 24-h BPM parameters.

Efficacy of Self-Expandable Absorbable Stents during Liver Transplant to Minimize Early Biliary Complications.

We analyzed the use of a self-expandable absorbable biliary stent (SEABS) to reduce biliary complications in liver transplant (LT). Complications related to biliary anastomosis are a still a challenge in LT with a high impact on the patient outcomes and hospital costs. This non-randomized prospective study was conducted between July 2019 and September 2023 in adult LT patients with duct-to-duct biliary anastomoses. The primary endpoint was to assess early biliary complications at 90 days in LT patients with intraoperative SEABS versus no SEABS. We also compared overall biliary complications, costs and SEABS- adverse effects related. A total of 158 patients were included, 78 with SEABS and 80 no-SEABS (22 T-tube and 58 no-stent). There were no adverse effects related to SEABS. Early biliary complications (23.8 vs 2.6%, P <0.001) and hospital stay (19 vs 15 days, P= 0.001) were higher in no-SEABS. No-SEABS group required 63 ERCPs and 13 surgeries (including 2 LT) versus 35 ERCPs and 2 surgeries in SEABS group. After PSM between SEABS (n=58) vs no-SEABS (n=58), early biliary complications (40% vs 0%, P<.001) were higher in no-SEABS group. T-tube had more early biliary complications (22.7% vs 5%, P=0.23) compared SEABS high-risk biliary anastomosis. SEABS excess cost per patient was lower compared to T-Tube and no-stent (6.988€ vs 17.992€ vs 36.364€, P=0.036 and P=0.002, respectively). SEABS during biliary anastomosis in LT is feasible with no adverse effects and avoid the T-tube in high-risk biliary anastomoses. It use has been associated with less early biliary complications, hospital costs and reoperations or interventional treatments for biliary complications resolution.

Comparison of Titanium Mesh Cage, Nano-Hydroxyapatite/Polyamide Cage, and 3D-Printed Vertebral Body for Anterior Cervical Corpectomy and Fusion.

A prospective non-randomized controlled study. To compare the clinical and radiographic outcomes of anterior cervical corpectomy and fusion (ACCF) using titanium mesh cages (TMC), nanohydroxyapatite/polyamide66 (n-HA/PA66) cages, and 3D-printed vertebral bodies (3d-VBs). Postoperative subsidence of TMCs in ACCF had been widely reported. Newer implants such as n-HA/PA66 cages and 3d-VBs using biocompatible titanium alloy powder (Ti6Al4V) had been introduced to address this issue, but their outcomes remain controversial. We enrolled 60 patients undergoing ACCF using TMCs, n-HA/PA66 cages, or 3d-VBs from January 2020 to November 2021. For each group, there were 20 patients. Follow-up was conducted for minimum two years. Clinical outcomes, including Japanese Orthopaedic Associationscores (JOA), Neck Disability Index (NDI) and Visual Analogue Scale (VAS) scores and radiographic outcomes, including FSU height, fusion rate, and cervical alignment were collected pre-operatively and at each follow-up. A loss of FSU height equal or greater than 3mm was deemed implant subsidence. One-way analysis of variance was used for comparisons of mean values at different time points within the same group, with pairwise comparisons performed using the LSD method. The Mann-Whitney test was used for comparisons between groups. Categorical data such as gender, smoking status, implant subsidence and pathology level were analyzed using the chi-square test. Postoperative function of spinal unit (FSU) height loss at 2 years differed significantly among the TMC, n-HA/PA66, and 3d-VB groups, measuring 3.07±1.25mm, 2.11±0.73mm, and 1.46±0.71mm, respectively (P<0.001). The rates of implant subsidence were 45%, 20%, and 10%, respectively (P=0.031). All patients obtained solid fusion at 2-year follow-up. We observed statistically significant differences in VAS and JOA scores at 3 months postoperatively, and JOA scores at 2 years postoperatively among the three groups. At two-year follow-up, the n-HA/PA66 and the 3d-VBs groups exhibited less FSU height loss, lower subsidence rates and demonstrated better cervical lordosis than the TMC group. No severe postoperative complications were observed in any of the patients, and no patient required reoperation. At two-year follow-up after ACCF, the n-HA/PA66 and the 3d-VBs groups exhibited less FSU height loss, lower subsidence rates and demonstrated better cervical lordosis than the TMC group. Longer term observation of implant subsidence in ACCF using TMC, n-HA/PA66, and 3d-VB, is necessary. Therapeutic Level III.

Tumor spread through air spaces in lung cancer: prospective analysis of the accuracy of intraoperative frozen section examination.

To establish the accuracy of frozen section examination in identifying tumor spread through air spaces (STAS), as well as to propose a reproducible technical methodology for frozen section analysis. We also aim to propose a method to be incorporated into the decision making about the need for conversion to lobectomy during sublobar resection. This was a nonrandomized prospective study of 38 patients with lung cancer who underwent surgical resection. The findings regarding STAS in the frozen section were compared with the definitive histopathological study of paraffin-embedded sections. We calculated a confusion matrix to obtain the positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity and accuracy. The intraoperative frozen section analysis identified 7 STAS-positive cases that were also positive in the histopathological examination, as well as 3 STAS-negative cases that were positive in the in the histopathological examination. Therefore, frozen section analysis was determined to have a sensitivity of 70%, specificity of 100%, PPV of 100%, NPV of 90.3%, and accuracy of 92% for identifying STAS. Frozen section analysis is capable of identifying STAS during resection in patients with lung cancer. The PPV, NPV, sensitivity, and specificity showed that the technique proposed could be incorporated at other centers and would allow advances directly linked to prognosis. In addition, given the high accuracy of the technique, it could inform intraoperative decisions regarding sublobar versus lobar resection.

Transforaminal lumbar endoscopic discectomy: should we abandon it for L5-S1 foraminal and extraforaminal lumbar disc herniations? A prospective non-randomised study and literature review

Purpose The aim of this study is to investigate the clinical outcomes of transforaminal lumbar endoscopic discectomy (TLED) in patients with L5-S1 lumbar disc herniation (LDH). Materials and methods Seventy-five consecutive individuals with diagnosed foraminal/extraforaminal L5-S1 LDH were included in this study. All patients underwent TLED, being subsequently evaluated in a 2-year follow-up period. Assessment was performed preoperatively and at 6 weeks and 3, 6, 12 and 24 months postoperatively. Visual Analogue Scale (distinctly applied for lower limb – VAS-LP and low back – VAS-BP pain) and Short-Form 36 (SF-36) Medical Health Survey Questionnaire were implemented to assess pain and health-related quality of life (HRQoL) of enrolled individuals, respectively. Results No major perioperative complications were observed. Recorded values of all studied indices were demonstrated to feature a clinically and statistically significant amelioration at 6 weeks, presenting lesser improvement at 3 months with subsequent stabilisation. VAS-LP and VAS-BP values were displayed to reach a plateau in 6 months postoperatively, whereas all parameters of SF-36 continued to present a statistically significant improvement until the end of follow-up at 2 years. Conclusions TLED represent a safe and efficient technique in terms of diminishing perceived pain and improving HRQoL in patients with L5-S1 LDHs. However, specific patient- and technique-related circumstances on the ground of low surgical experience may limit its effectiveness in these patients.

Introduction and Effectiveness of Early Clinical Exposure Among Dental Students in Pre-clinical Prosthodontics.

Lack of patient contact in the pre-clinical prosthodontics curriculum makes it difficult for the students to comprehend and correlate the series of complex steps involved in complete denture fabrication. Early clinical exposure in the second year of the undergraduate program will facilitate a smooth transition of dental students from pre-clinics to clinics, thereby helping to mitigate the lacunae existing in the present curriculum. A non-randomized prospective educational interventional study was conducted among 50 second-year dental students. Early clinical exposure in the form of clinical demonstration for complete denture steps of border molding and jaw relation was given subsequent to the completion of didactic and laboratory sessions. Pre- and post-multiple-choice question tests were conducted to explore students' knowledge. Student perception towards early clinical exposure was assessed using a self-administered anonymous questionnaire, while faculty perception was gauged with the help of in-depth interviews. A statistically significant difference was observed when pre- and post-multiple-choice question test mean scores were compared, showing an overall improvement in students' knowledge following early clinical exposure. Students and faculty held a positive perception towards the program and found it to be useful in enhancing the overall learning experience of the students.Faculty expressed their concern regarding limited manpower, paucity of time, and difficulty in integrating early clinical exposure into the present timetable. Early clinical exposure can be integrated into the traditional pre-clinical prosthodontics curriculum with appropriate time and manpower allocation. Faculty sensitization and training workshops need to be conducted before implementing this program.