Prospective Single Center Research Articles

Assessment of Nutritional Status by Bioelectrical Impedance in Adult Patients with Celiac Disease: A Prospective Single-Center Study.

The gluten-free diet [GFD] has been linked to an increased risk of weight gain and the development of metabolic disorders. Most of the studies have focused on the effect of GFD on the Body Mass Index [BMI]. We aimed to evaluate the nutritional status using specific nutritional parameters in patients with celiac disease [CeD] at diagnosis and on a GFD compared to healthy controls. We recruited subjects at our outpatient clinic at the University of Padua. We collected demographic and clinical data and values obtained with bioelectrical impedance analysis. A total of 24 CeD patients and 28 healthy controls were enrolled. CeD patients at diagnosis had a lower body cell mass index [BCMI, p = 0.006], fat-free mass index [FFMI, p = 0.02], appendicular skeletal muscle index [ASMI, p = 0.02], and phase angle [PA] [p < 0.001] compared to controls. Their percentage of extracellular water [ECW] was also higher [p < 0.001]. Considering CeD patients after GFD, nutritional status significantly improved after 6 months of GFD. We did not observe differences in BMI among groups [p = ns]. CeD patients at diagnosis were found to have a poorer nutritional status than healthy controls, with a positive effect of the GFD on their nutritional status, underlining the inefficacy of evaluating this aspect through only BMI evaluation.

The Fate of Patients Opportunistically Screened for Abdominal Aortic Aneurysms During Echocardiogram or Arterial Duplex Scans

To evaluate the long term outcomes of individuals who attended for transthoracic echocardiograms (TTEs) or lower limb arterial duplex scans (LLADS) and were opportunistically screened for abdominal aortic aneurysms (AAA). Follow up of a prospective single centre pilot cohort study conducted between December 2012 and September 2014 at a tertiary vascular centre in the United Kingdom. Men and Women aged 65 and over were invited to undergo AAA screening when attending hospital for TTE or LLADS. Screening was performed by ultrasonographic examination of the abdomen at the end of their planned scans. AAA was defined as an abdominal aorta outer wall to outer wall anteroposterior diameter of 30 mm or more. Patients were excluded if they had a known AAA or previous abdominal aorta intervention. Follow up outcomes were evaluated in December 2020. 762 patients were enrolled in this study; 486 had TTE and 276 patients had LLADS. The overall incidence of AAA was 54 (7.1%) in the combined cohort, 25 (5.1%) in the TTE group, and 29 (10.5%) in the LLADS group. After a median 7.6 years, two of the 54 AAAs received intervention in the form of endovascular repair. Three others reached treatment threshold but were managed conservatively. The overall intervention rate was 3.7% of detected AAAs. Adjusted mortality rates in those with AAA vs. without was 64.8% and 36%, respectively (hazard ratio [HR] 2.02, p < .001). Diabetes (HR 1.35, p= .015) and older age (HR 1.18, p= .17) were the other factors associated with death. AAA is associated with a significantly increased mortality rate. Populations attending hospital for TTE or LLADS demonstrate a higher prevalence of AAA than population based screening; however, the proportion offered AAA intervention was low. Further research into opportunistic screening should target those more likely to undergo AAA repair, unless other interventions are demonstrated, to reduce the general increased mortality in AAA patients.

Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients with Severe Pneumonia

ObjectiveThis study aimed to evaluate the clinical benefits of a vancomycin dosage strategy based on a serum trough concentration model in elderly patients. MethodsThis prospective single-center, open-label, randomized controlled trial categorized 66 elderly patients with severe pneumonia into study and control groups. The control group received vancomycin using a regimen decided by the attending physician. Meanwhile, the study group received individualized vancomycin therapy with a dosing strategy based on a serum trough concentration model. The primary endpoint was the proportion of patients with serum trough concentrations reaching the target values. The secondary endpoints were clinical response, vancomycin treatment duration, and vancomycin-associated acute kidney injury (VA-AKI) occurrence. ResultsAll patients were at least 60 years old (median age = 81 years). The proportion of patients with target trough concentration achievement (≥ 15 mg/L) with the initial vancomycin regimen was significantly higher in the study group compared to the control group (75.8% vs. 42.4%, P = 0.006). Forty-five patients (68.2%) achieved clinical success, the median duration of vancomycin therapy was 10.0 days, and VA-AKI occurred in eight patients (12.1%). However, there were no significant differences in these parameters between the two groups. The model for predicting vancomycin trough concentrations was upgraded to: serum trough concentration (mg/L) = 17.194 − 0.104 × creatinine clearance rate (mL/min) + 0.313 × vancomycin daily dose [(mg/(kg·d)]. ConclusionA vancomycin dosage strategy based on a serum trough concentration model can improve the proportion of patients achieving target trough concentrations in elderly patients with severe pneumonia.

The Effect of Sexual Intercourse during Pregnancy on Preterm Birth: Prospective Single-Center Cohort Study in Japan.

Several studies in Europe and the United States have shown that sexual intercourse (SI) during pregnancy is not associated with preterm birth. However, it is unclear whether these findings apply to pregnant Japanese women. The aim of this prospective cohort study was to elucidate the influence of SI during pregnancy on preterm birth in Japan. A total of 182 women who underwent antenatal care and delivery were included in this study. The frequency of SI was assessed using a questionnaire, and its association with preterm birth was analyzed. The results showed that SI during pregnancy was associated with a significantly higher cumulative preterm birth rate (p = 0.018), which was more pronounced for SI more than once a week (p < 0.0001). Multivariate analysis showed that SI, bacterial vaginosis in the second trimester, previous preterm birth, and smoking during pregnancy were independent risk factors for preterm birth. The combination of SI and second trimester bacterial vaginosis was associated with a 60% preterm birth rate, whereas either factor alone was associated with a lower rate, suggesting a synergistic effect (p < 0.0001). Future studies are needed to investigate the effect of prohibiting SI in pregnant women with bacterial vaginosis on preterm birth.

Comparison of conventional clinical models and a multigene assay to assess DCIS risk in a prospective single center study.

e12578 Background: Ductal carcinoma in situ (DCIS) is a preinvasive breast cancer typically excised and treated with adjuvant therapy. While there is consensus that this results in overtreatment, there is little agreement on who may avoid radiation or endocrine therapy. Two freely available prediction models, Van Nuys Prognostic Index (VNPI) and Memorial Sloan Kettering Nomogram (MSK-N), are commonly used to identify low-risk DCIS based on standard clinicopathological features. Oncotype DCIS is a newer commercially available tissue-based multigene assay also used to assess risk, but its use is limited due to cost and unclear value over VNPI and MSK-N. We sought to compare these tests’ agreement in determining DCIS ipsilateral breast recurrence (IBR) risk and potential to de-escalate therapy. Methods: In this subanalysis from a prospective single center clinical trial, we analyzed 38 patients with newly diagnosed pure DCIS confirmed at excision. Each risk assessment tool presents risk in a different manner. Oncotype DCIS provides multiple assessments: a raw score (0-100), a DCIS Score Category (low, intermediate, high), and a Refined Score incorporating clinical features (10-year IBR risk). The VNPI calculates a raw score (4-12) and assigns a risk category (low, intermediate, high). MSK-N calculates a 10-year IBR risk. The tests were dichotomized as low vs. not-low risk categories using these thresholds: DCIS Score Category = low, DCIS Refined Score ≤ 10% IBR risk, VNPI risk category = low, MSK-N ≤ 10% IBR risk. Agreement of the 4 models (DCIS Score Category, DCIS Refined Score, VNPI, MSK-N) were compared using Spearman’s rank correlation for continuous data; percent agreement and Cohen’s kappa (k) were used to compare categorized data. Results: There was poor agreement of continuous risk assessments across the 4 models, with only VNPI and DCIS Refined Score showing significant but moderate correlation (r = 0.53, p = 0.001; others ranged r = 0-0.27, p &gt; 0.1). The number of cases identified as low-risk for each assay was DCIS Score Category = 14 (37%), DCIS Refined Score = 3 (8%), VNPI = 1 (3%), and MSK-N = 0. Percent agreement of low vs. not-low risk categorizations between DCIS Refined Score, VNPI, and MSK-N was 92-97%, but each assay classified 3 or fewer cases as low-risk and kappa was not significant (k = 0-0.48, p &gt; .1). DCIS Score Category demonstrated 63-71% agreement with the other 3 assays (k = 0-0.26). Only 1 case was classified as low-risk DCIS on multiple tests. Conclusions: DCIS risk models have poor agreement for determining IBR risk. DCIS Score Category initially identified many low-risk lesions; however, inclusion of clinical features to create a Refined Score decreased this substantially, providing very few additional low-risk cases for de-escalation over VNPI or MSK-N. Additional studies are needed to determine precise IBR rates when these models are used for adjuvant therapy decision-making. Clinical trial information: NCT03495011 .

Head-to-head comparison of 68Ga-PSMA-11 PET with 99mTc-MDP bone scan for detection of bone disease in patients with prostate cancer with biochemical progression during ADT: A single center prospective study.

e17072 Background: 68Ga-PSMA-11 PET/CT (PSMA-PET) was approved by the U.S. Food and Drug Administration in patients with prostate cancer (PCa) at primary staging or biochemical recurrence. A head-to-head comparison between PSMA-PET and conventional imaging (99mTc-MDP bone scan [BS] and CT) in men with advanced prostate cancer was not performed. We aimed to compare the detection rate of bone disease for PSMA-PET vs BS in men with PCa and with biochemical progression during androgen deprivation therapy (ADT). Methods: This was a prospective single-center, open-label, single-arm, head-to-head comparison, prospective phase 2 study (NCT04928820). A sample size of 102 men was required to achieve an 80.3% power to detect a difference of 12% positivity rate of bone disease in favor of PSMA-PET vs BS (35% vs 23%). Men with i) biopsy-proved PCa, ii) who had rising PSA levels on 2 successive occasions ≥1 week apart, iii) were receiving treatment with hormonal therapy, iii) and had an absolute PSA value ≥1 ng/ml were eligible. Men who were enrolled received PSMA-PET and bone scan within 30 days. The primary endpoint was detection rate of bone disease for PSMA-PET vs BS. Secondary endpoint was the number of bone lesions detected by PSMA-PET vs BS. Number of lesions was categorized into: 0 vs 1 vs 2 vs 3 vs 4 vs 5 vs &gt; 5. A p value &lt; 0.05 was considered statistically significant. Results: 22 men were enrolled between July 8, 2021 and June 9, 2022. The median patients age was 71 years (range: 56-94). The median time between scans was 12 days (range: 1-29). The median PSA value was 9.5 ng/ml (range: 1.2 – 1717). 11/22 (11%) patients had hormone-sensitive PCa, while 11/22 (50%) had castration-resistant PCa prior to receiving the scans. The positivity rate for bone disease was equal for PSMA-PET and BS in all cases: 7/22 (32%) patients had negative scans on both imaging modalities and 15 (68%) had ≥1 bone lesion detected on both imaging modalities (p = 1.00). In 15/22 (68%) men, both imaging modalities showed equal number of bone lesions: 0 lesions in 7/22 (32%) men and &gt; 5 lesions in 8/22 (36%) men. In 3/22 (14%) men BS showed higher number of lesions, while in 4/22 (18%) men PSMA-PET showed higher number of lesions. No statistical difference was noticed between PSMA-PET and BS in number of bone lesions detected (p &gt; 0.05). The trial was terminated early since these preliminary results gave already a 95% confidence interval of 81-100% for equivalent positivity rate of bone disease between PSMA-PET and BS. Conclusions: In this prospective study of patients with prostate cancer with rising PSA levels under hormonal therapy, 68Ga-PSMA-11 PET and 99mTc-MDP bone scan had similar detection rate for bone disease. Further studies investigating similar comparison between PSMA-PET and BS in clinically-relevant selected patient population are warranted. Clinical trial information: NCT04928820 .

COVID-19 vaccination in patients with cancer: Results from survey based observational study.

e18897 Background: COVID‐19 (C19) disproportionately affects those with comorbid medical conditions, leading to significantly higher mortality rate. Cancer(ca) is a well-studied risk factor for developing severe C19 disease. However, ca patients (pts) were largely excluded from clinical trials evaluating the safety and efficacy of 3 FDA-approved C19 vaccines (vax). We aim to study this highly vulnerable pts’ behavior and outcomes regarding C19 vax. Methods: A prospective and observational single center study. Adult ca pts (18-89 years) seen in clinics from Nov 2021-Sept 2022 were randomly interviewed using telephone surveys after a verbal consent. Type of ca and therapy data were collected from pts’ medical records. The survey included C19 disease status, vax status positive (vax+) or negative (vax-), reason for vax status, s.e, impact on ca Rx or ca progression. Our primary objectives were to assess the rate of vaccination in the adult ca pts and identify barriers to vaccination. Secondary objectives were determining factors associated with vax acceptance vs. hesitancy, identifying s.e of C19 vax, and effect of C19 vax on clinical outcomes in ca pts. Results: N = 170 [Males 82 (48.2%) and females 88 (51.8%)]. The median age was 65 years. Among 170 pts, 58.2% had solid malignancy, 40% had hematologic malignancy, and 1.8% had both solid and hematologic malignancy. Refer to Table 1 for outcomes data. Overall, 146 (85.9%) pts received C19 vax. C19 infection positive (C19+) in 49 (28.8%) pts. Of them 9 (18.4%) pts required hospitalization. The vax rate of prior C19+ pts was 73.5% compared to 90.9% in C19 infection negative (C19-) pts (p = 0.0013). Demographic factors were not significantly associated with vaccine uptake. A total of 50% pts developed s.e from vax. However only one patient (0.68%) reported a delay in ca treatment due to C19 vax and believed that vax affected the ca outcome. Conclusions: Our results demonstrate that majority of the ca pts were vaccinated against C19 and tolerated it well, with minimal side effects. Prior C19 infection significantly decreased vax uptake. Vaccination did not have notable adverse effect on ca outcomes. Oncologists should discuss the importance of C19 vax in the context of ca to avoid misconceptions and hesitancy. Clinical trial information: NCT04953065 . [Table: see text]

Indicators of immune status in women with different recurrence rates of nonspecific inflammatory diseases of the genital organs

Non-specific inflammatory diseases of the female genital organs (NIDFGO) are an important problem of modern gynecology due to their high frequency in the population, the tendency to frequent recurrences, and many cases of resistance to recommended antimicrobial and anti-inflammatory drugs. Aim: to study indicators of immune status in women with different recurrence rates of NIDFGO and biomarkers of recurrences to improve potential therapeutic approaches and prevent recurrences in the further. Materials and methods. A prospective single-center controlled non-randomized clinical study was conducted with the participation of 98 adult women. Out of them, 80 patients with NIDFGO had one-year recurrence rate of 1, 2–3, 4 or more events, and 18 age-matched women without NIDFGO were assigned to the control group. Immunogram and hemogram were performed for all study participants using standardized methods. Statistical analysis of the results was performed using IBM SPSS 23 statistical package software. Results. The mean serum concentration of IgE in patients with frequent relapses was 3 times (p &lt; 0.05) lower than that in women with only one recurrence, 2.6 times (p &lt; 0.05) lower than that in patients with medium recurrence rate, and 3.4 times (p &lt; 0.05) less than in the control. In women with frequent recurrences, the mean relative number of blood NKT cells was 3.5 times (p &lt; 0.05) less than that in patients with only one recurrence, 2.3 times (p &lt; 0.05) less than that in persons with medium recurrence rate, and 3 times (p &lt; 0.05) less as compared to women of the control group. Conclusions. Selective deficiencies of IgE and NKT cells in women with NIDFGO are factors that lead to a higher frequency of disease exacerbations per year. T he development and clinical approval of immunotherapeutic approaches to compensate for deficiencies of IgE and NKT cells in women with NIDFGO will contribute to the imposition of immune control over the inflammatory process, increase the effectiveness of antimicrobial treatment, resulting in a decrease in the recurrence rate.

Effects of nurse delivered thoracic ultrasound on management of adult intensive care unit patients: A prospective observational study

BackgroundThoracic ultrasound is a valuable tool that helps diagnose cardiopulmonary disorders and guide management in intensive care unit patients. Intensive care unit nurses were trained to perform thoracic ultrasound examinations, after which they were named ‘UltraNurses’ for clinical recognizability. UltraNurses demonstrated rapid learning trajectories, but the impact on clinical-decision making remained unknown. The aim of this study was to investigate the effects of UltraNurse ultrasound on clinical management. MethodsThis was a prospective observational single center study within a mixed medical and surgical intensive care unit. All adult patients with an indication for UltraNurse thoracic ultrasound were included. The study consisted of three steps: pre- and post- data collection, with the ultrasound examination conducted in-between these two steps. The examination consisted of a standardized ultrasound protocol aimed at the lungs and cardiac output. Primary outcome was what percentage of ultrasounds led to a change of management. Secondary outcomes included: percentage of changes executed within first 8 hours, frequency of pathology found, percentage of diagnosis change, and frequency of UltraNurse ultrasounds per shift. ResultsA total of 102 ultrasound examinations were performed in 65 patients (89% mechanically-ventilated). Ultrasound examinations suggested changes of management in 26% of cases, of which 96% were executed within 8 hours. Most changes were within the nursing scope (56%), specifically: 44% of examinations changed fluid management. UltraNurse ultrasound detected pathology in 97% of cases. In 7% of cases, the diagnosis was changed, sometimes leading to life-saving interventions. UltraNurses performed one thoracic ultrasound examination per four shifts. ConclusionIn adult intensive care unit patients, UltraNurse thoracic ultrasound led to a change of management in more than a quarter of the cases, of which almost all were executed within the first 8 hours. Study registrationNetherlands Trial Registration NL9047, VUmc 2020.011 (prospectively registered on: 13–11–2020)

Sepsis is the most frequent trigger for electrical storm in structural heart disease: results from a tertiary referral centre prospective registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Electrical storm is a specific clinical presentation yielding to high morbidity and mortality. Acute development of electrical storms results from the underlying myocardial substrate, autonomic activation, and trigger factors. Main therapeutic approaches range from pharmacological to interventional treatment. Methods We enrolled in a prospective single center registry all patients admitted from March 2018 to March 2022 at our Centre who satisfied diagnostic criteria for electrical storm. Demographic, instrumental, and interventional data were obtained from local electronic health record. Results A total of 87 patients (79% male sex, mean age 72,21±10,49 years) were enrolled. Mean left ventricular ejection fraction was 37,27±11,62%. Underlying cardiomyopathy was ischemic in 57,47%; dilated cardiomyopathy in 20,69%, arrhythmogenic cardiomyopathy in 8%, other in 13,84%. A definite trigger was identified in 34 cases (39%), most frequent ones were sepsis (11 events, 32,4%), acute heart failure (6 events, 17,6%), myocardial ischemia (5 events, 14,7%), thyrotoxicosis (5 events, 14,7%), ionic disorder (4 events, 11,8%). An ICD was already implanted in 89,66% of patients, all remaining patients were implanted during index hospitalization. An ablation strategy was pursued in 65,52% of cases. Mean days from hospitalization to ablation were 7±5. Median hospital stay was 11 days (IQR 8-18). Conclusion In our single referral centre experience, in patients with electrical storm, ischemic cardiomyopathy was the dominant underlying heart disease. An identifiable trigger was found in a large cohort of patients, with sepsis being the most frequent. An ablation strategy was pursued in most cases.

Progression and regression in the left atrial substrate in patients with atrial fibrillation: the PROGRESS-AF study

Abstract Funding Acknowledgements Type of funding sources: None. Background Progression or regression of the atrial substrate in atrial fibrillation (AF) has been demonstrated in animal models and human right atrial maps. Dynamic changes over time of the left atrial (LA) substrate in patients with AF have not been evaluated in detail yet. Purpose To evaluate changes of the LA substrate between first and redo AF ablation procedures. Methods In our prospective single center observational study, consecutive patients undergoing first and redo AF ablation during sinus rhythm were included. The LA was divided into anterior, septal, lateral and inferior regions. The veins and posterior segments were excluded from the analysis. In each segment median voltages and area % of spontaneous low voltage zone (LVZ) of the LA (&amp;lt;0.5 mV) were measured and compared between first and second procedure in each patient. Progression/Regression was diagnosed if a significant concordant decrease/increase in the median voltage in at least two regions was observed, respectively. Results In the first procedure 34.055 (1.216 points/patient) and in the second 76.958 (2.748 points/patient) points were analyzed in 28 patients (age: 61.2±9.5 years, 39% female, 39% persistent AF). The time between first and second procedure was 1.2 (0.4-2.3) years. Eleven (39%) patients had spontaneous &amp;gt;5% LVZ at both first and second procedure (p=1). In 17 (60%) patients progression was identified; in 5 patients in all 4 segments, in 8 in 3 and in 4 in 2. In the Progression group the total mean LA voltage (1.28±1.30 vs. 0.76±0.71 mV, p&amp;lt;0.001) and the regional mean voltage in all atrial regions decreased significantly: anterior: 0.80±0.76 vs. 0.52±0.51, p&amp;lt;0.001; septal: 1.04±0.94 vs. 0.68±0.57,p&amp;lt;0.001; lateral: 1.71±1.60 vs. 1.04±1.01, p&amp;lt;0.001; and inferior 1.69±1.58 vs. 0.80±0.62, p&amp;lt;0.001. The % LVZ increased not significantly: 6.3±9.5% vs. 9.8±10.1%, p=0.3. In 11 (40%) patients regression was observed (in 3 patients in 3 regions and in 8 in 2). In the Regression group the total mean LA voltage (1.47±1.35 vs. 1.89±1.56, p&amp;lt;0.001) and the regional mean voltage in all but one atrial regions increased significantly: anterior: 1.60±1.55 vs. 1.84±1.58, p=0.001; lateral: 1.59±1.26 vs. 2.59±1.81, p&amp;lt;0.001; inferior: 1.29±1.10 vs. 1.84±1.33, p&amp;lt;0.001; and septal: 1.36±1.43 vs. 1.25±1.18, p=0.06. The % LVZ decreased not significantly (8.6±9.5% vs. 4.1±10.1%, p=0.1). There was no significant difference in any baseline clinical or echocardiographic parameter between the Progression and Regression group. Conclusions Our preliminary study is the first to report bidirectional dynamic properties of the LA substrate with concordant either progressive or regressive changes of atrial voltage in different atrial regions outside of the PVs following AF ablation. A better understanding of the dynamic changes of the LA substrate could help to differentiate between patients with reversible and despite ablation therapy progressive irreversible atrial structural remodeling.

Evaluation of Five Host Inflammatory Biomarkers in Early Diagnosis of Ventilator-Associated Pneumonia in Critically Ill Children: A Prospective Single Center Cohort Study.

Background: Early diagnosis of ventilator-associated pneumonia (VAP) remains a challenge due to subjective clinical criteria and the low discriminative power of diagnostic tests. We assessed whether rapid molecular diagnostics in combination with Clinically Pulmonary Index Score (CPIS) scoring, microbiological surveillance and biomarker measurements of PTX-3, SP-D, s-TREM, PTX-3, IL-1β and IL-8 in the blood or lung could improve the accuracy of VAP diagnosis and follow-up in critically ill children. Methods: A prospective pragmatic study in a Pediatric Intensive Care Unit (PICU) was conducted on ventilated critically ill children divided into two groups: high and low suspicion of VAP according to modified Clinically Pulmonary Index Score (mCPIS). Blood and bronchial samples were collected on days 1, 3, 6 and 12 after event onset. Rapid diagnostics were used for pathogen identification and ELISA for PTX-3, SP-D, s-TREM, IL-1β and IL-8 measurements. Results: Among 20 enrolled patients, 12 had a high suspicion (mCPIS > 6), and 8 had a low suspicion of VAP (mCPIS < 6); 65% were male; and 35% had chronic disease. IL-1β levels at day 1 correlated significantly with the number of mechanical ventilation days (rs = 0.67, p < 0.001) and the PICU stay (r = 0.66; p < 0.002). No significant differences were found in the levels of the other biomarkers between the two groups. Mortality was recorded in two patients with high VAP suspicion. Conclusions: PTX-3, SP-D, s-TREM, IL-1β and IL-8 biomarkers could not discriminate patients with a high or low suspicion of VAP diagnosis.

Clinical &amp; etiological profile of new onset unprovoked seizure in children aged 2 months to 18 years

Seizure is defined as abnormal paroxysmal neuronal discharge, which is clinically manifested by motor, sensory, autonomic or behavioral disturbances. Seizures are common in pediatrics age group and occur in 10% of children. Less than 1/3of seizures in children are caused by epilepsy. The objective of the study was to determine the clinical and etiological profile of new onset unprovoked seizure in children aged between 2 month to 18 years. A hospital based prospective single centre study at RNT Medical College, Udaipur. 111 patients admitted in Balchikitsalya with new onset unprovoked seizures during one year. Out of 111 patients with new onset unprovoked seizures, majority of patients were between 1-5 years of age with male predominance. In which most common diagnosis was seizure disorder in 78 pts (70.2%) [Generalised 76 pts (97.4%) &amp;#62; Focal 2 pts (2.6%)] followed by 13.5% hypocalcemic seizure, 8.1% hypoglycemic seizure. Other diagnosis was tuberous sclerosis (2.7%), white matter changes (1.8%), adrenoleukodystrophy (0.9%), arachnoid cyst (0.9%), tuberculoma (0.9%) and HIE changes (0.9%). EEG abnormality was seen in 46% of patients. Hyponatremia (36%) was significantly associated with abnormal EEG changes. MRI was done in 38.7% of the patients, out of which, abnormality was seen in only 8.6% of the children. Seizure is mainly diagnosed clinically and EEG can be normal in many patients. First episode of unprovoked seizure was common in age group of 1-5 years. EEG and Neuroimaging is useful for better diagnosis, treatment can be started on clinical diagnosis.

Effects of acromegaly treatment on left ventricular systolic function assessed by speckle tracking echocardiography in relation to sex differences: results from a prospective single center study.

Despite the preserved LVEF, patients with acromegaly are characterized by subclinical systolic dysfunction i.e., abnormal global longitudinal strain (GLS) assessed by speckle tracking echocardiography (STE). The effect of acromegaly treatment on LV systolic function assessed by STE, has not been evaluated so far. Thirty-two naïve acromegalic patients without detectable heart disease were enrolled in a prospective, single-center study. 2D-Echocardiography and STE were performed at diagnosis, 3&6 months on preoperative somatostatin receptor ligand (SRL) treatment and 3 months after transsphenoidal surgery (TSS). Treatment with SRL resulted in reduction in median (IQR) GH&IGF-1 levels after 3 months, from 9.1(3.2-21.9) to 1.8(0.9-5.2) ng/mL (p<0.001) and from 3.2(2.3-4.3) to 1.5(1.1-2.5) xULN (p<0.001), respectively. Biochemical control on SRL was achieved in 25.8% of patients after 6 months and complete surgical remission was achieved in 41.7% of patients. TSS resulted in decrease in median (IQR) IGF-1 compared to IGF-1 levels on SRL treatment: from 1.5(1.2-2.5) to 1.3(1.0-1.6) xULN (p=0.003). Females had lower IGF-1 levels at baseline, on SRL and after TSS compared to males. The median end diastolic and end systolic left ventricle volumes were normal. Almost half of the patients (46.9%) had increased LVMi, however the median value of LVMi was normal in both sex groups: 99g/m2 in males and 94g/m2 in females. Most patients (78.1%) had increased LAVi and the median value was 41.8mL/m2. At baseline 50% of patients, mostly men (62.5% vs. 37.5%) had GLS values higher than -20%. There was a positive correlation between baseline GLS and BMI r=0.446 (p=0.011) and BSA r=0.411 (p=0.019). The median GLS significantly improved after 3 months of SRL treatment compared to baseline: -20.4% vs. -20.0% (p=0.045). The median GLS was lower in patients with surgical remission compared to patients with elevated GH&IGF-1 levels: -22.5% vs. -19.8% (p=0.029). There was a positive correlation between GLS and IGF-1 levels after TSS r=0.570 (p=0.007). The greatest beneficial effect of acromegaly treatment on LV systolic function is visible already after 3 months of preoperative SRL treatment, especially in women. Patients with surgical remission have better GLS compared to patients with persistent acromegaly.

The short-term false positives after sacral neuromodulation therapy: Who, how many and why? A prospective descriptive single centre study

Aim:I. To describe the number of false positive cases (FP), their characteristics and reason of occurrence in sacral neuromodulation therapy (SNM). Methods:A multidisciplinary prospective single-centre study was conducted between March 2018 and December 2021 with a follow-up of 12 months. Patients with therapy-resistant pelvic organ dysfunctions, scheduled for a 2-staged SNM procedure at the Urology (UD) and Colorectal Surgery Department (CRD), were included. All patients completed bowel and bladder diaries at baseline and during the test phase. Patient global impression of change (PGIC) and satisfaction scores concerning urological (US) and bowel symptoms (BS) were surveyed at baseline, at 1, 6 and 12 months after implantation. Patient characteristics and diary outcomes between FP and true positive cases (TP) were compared using non-parametric statistical tests. SPSS 27.0 was used. Clinical trial registration: NCT05313984. Results:The FP ratio at one month follow-up was 16% (11/68), with a FP ratio of 13% (N=6/48) and 25% (N=5/20) for the urology patients and colorectal surgery patients, respectively. There were no significant differences in demographic characteristics between the FP and TP group (p > 0,05), however there is a trend towards FP having worse baseline symptoms than TP. The FP group had a significant lower baseline and test phase 24 h diuresis (p < 0,05), without having a significant different intake than the TP group. Conclusion:At one month after full implantation of a sacral neuromodulator, 16% of the patients showed loss of subjective success. These FP could not be predicted from demographic characteristics, most likely due to the small study population. Although not significant, FP seem to have worse symptoms at baseline than TP, with a significant lower diuresis regardless of fluid intake.

Evaluation of mild periorbital cellulitis and home-based therapy in children-EPOCH study: A prospective single centre cohort study.

Paediatric periorbital cellulitis is a common eye condition and warrants prompt management for the prevention of complications. International consensus on the approach to optimal management of children with mild periorbital cellulitis including ambulatory management is lacking. We aimed to prospectively investigate the safety and effectiveness of ambulatory management of children with mild periorbital cellulitis. Over a 23-month period, we prospectively enrolled 70 children aged between 2 and 16 years who presented to the emergency department with mild periorbital cellulitis. Demographic and clinical data were collected. Eligible children were commenced on oral antibiotics and were discharged home with close outpatient ambulatory care and ophthalmology follow up. We used descriptive statistics for data presentation. Of the 70 children with mild periorbital cellulitis, 30 (43%) had unknown aetiology. Sixty-five (92%) children received a structured ambulatory follow up. Five children (7%) received inpatient parenteral antibiotics for worsening of local symptoms within 24 h of initial presentation. One child developed orbital cellulitis at follow up. There was no mortality or significant morbidity noted in this group and none of the children needed surgical intervention. Ambulatory care for children with mild periorbital cellulitis is an effective and safe management strategy. This might prevent hospitalisation, reduce the burden on hospital bed occupancy and promote patient care in the community.

Validation of the 25 level modified shuttle test in children with cystic fibrosis.

To evaluate the validity and reliability of the modified shuttle 25-level test (MST-25) in children with cystic fibrosis (CF). A prospective single center study in clinically stable children with CF. Participants undertook two testing conditions on different days: (1) 2xMST-25 tests; (2) cardiopulmonary exercise test (CPET). Test order was randomized. Nadir oxygen saturation (SpO2 ), peak heart rate (HR), breathlessness (modified Borg), rate of perceived exertion (RPE), energy expenditure (EE) and metabolic equivalents (MET) from the MST-25 and CPET were compared to assess validity, while outcomes from 2xMST-25 tests were compared for reliability. CPET was performed using breath-by-breath analysis and EE from the MST-25 obtained using the SenseWear Armband. Strong correlations were found between MST-25 distance and peak oxygen uptake, peak work and minute ventilation on CPET (all r > 0.7, p < 0.01). Moderate correlations were found between MST-25 distance and CPET for METs (r = 0.5) and HR (r = 0.6). Weak associations between tests were evident for nadir SpO2 (r = 0.1), modified Borg (rs = 0.2) and RPE (rs = 0.2). Test-retest reliability was excellent for MST-25 distance (ICC 0.91), peak EE (ICC 0.99) and peak METs (ICC 0.90). Good reliability was achieved for HR (ICC 0.84) and modified Borg score (ICC 0.77), while moderate reliability for nadir SpO2 (ICC 0.64) and RPE (ICC 0.68) was observed. The MST-25 is a valid and reliable field test for the assessment of exercise capacity in children with CF. The MST-25 can be used to accurately monitor exercise capacity and prescribe exercise training, particularly when CPET is not available.

Quality of Life in Patients with Papillary Thyroid Cancer Assessed with The Turkish Version of The Thyroid Related Patient-Reported Outcome Questionnaire ThyPRO: A Prospective Single Center Study

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

PROSPECTIVE OBSERVATIONAL STUDY COMPARING OUTCOMES AND COMPLICATIONS OF OPEN VS LAPAROSCOPIC NEPHRECTOMY

Introduction: Nephrectomy refers to surgical removal of the kidney and is further divided into simple, radical, partial and donor nephrectomy. Simple nephrectomy is conducted in irreversible kidney damage; radical nephrectomy in malignant or benign renal tumours while partial nephrectomy involves removal of part of kidney. Nephrectomy may be performed via open or laparoscopic approaches; although there is evidence favouring laparoscopy, supplementary evidence is necessary to establish it.2 This study aims to compare outcomes, complications and other parameters for laparoscopic and open surgical nephrectomy at a tertiary care centre in western India. To compare outcomes and Aim: complications for laparoscopic and open nephrectomy. Objectives: To compare: 1. Immediate and late complications. 2. A] Requirement of analgesia. B] Return of bowel functions. 3. Mean length of hospitalization and return to regular normal activity. Materials And Methods: A prospective observational single centre study was conducted at a tertiary care centre in western India. Total sample size was 49 of which 25 patients underwent laparoscopic nephrectomy while 24 patients underwent open nephrectomy. Intraoperative anaesthesia, trocar access, duration of surgery, blood loss, repeat haemoglobin and haematocrit value at post operative day 1, requirement of blood transfusion, duration of analgesics requirement, post-operative stay; histopathology report and time to resume normal activity at immediate follow up, follow up at 3 months and further follow up after surgery were noted down. Current study found statist Results: ically signicant relationship of higher intra-operative blood transfusion requirement and higher post-op requirement of Analgesia in case of open surgery. Moreover, among laparoscopy group there was signicantly lower blood loss during surgery, early time to oral diet, low pain VAS score, lower doses of Tramadol and early return to normal activity was found as compared to Open surgery group (p&lt;0.05). Laparoscopic nephrectom Conclusion: y results in less blood loss, less requirement of post operative analgesia and more rapid post operative recovery in comparison to open surgery

PROMs after Lymphatic Reconstructive Surgery: Is There a Correlation between Volume Reduction and Quality of Life?

We conducted a prospective single center study patients receiving lymphatic reconstructive surgery. Patients received volume measurements preoperatively and at standardized postoperative intervals. To evaluate patient-reported outcomes, patients completed the following questionnaires: LYMPH-Q Upper Extremity Module, quickDASH, SF 36, Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema, and Lower Extremity Functional Scale at the aforementioned intervals. We included 55 patients with upper limb lymphedema (24%) and lower limb lymphedema (73%) of lymphedema grades I-III. Patients received lymphovenous anastomosis only (23%), free vascularized lymph node transfer (35%) or a combination of both (42%). Analysis of patient-reported outcome measurements revealed improvements with respect to a broad range of complaints, particularly physical function, symptoms, and psychological well-being. There was no correlation between the extent of volume reduction and improvement in quality of life (Pearson correlation coefficient below ±0.7; P > 0.05). Based on a broad range of outcome measurements, we observed an improved quality of life in almost all patients, even in those without measurable volume loss of the extremity operated on, which emphasizes the need for a standardized use of patient-reported outcome measures to evaluate the benefits of lymphatic reconstructive surgery.