Single-center Prospective Study Research Articles

The Role of Rotational Thromboelastometry in Early Detection of the Hemostatic Derangements in Neonates with Systemic Candida Infection.

Systemic Candida infection (SCI) is the third most common cause of late-onset sepsis in Neonatal Intensive Care Units (NICU). While platelet involvement in fungal infections has been extensively studied, evaluation of the hemostatic mechanism in Candida infections, especially in neonates, has not been widely investigated. The aim of the current study was to evaluate the hemostatic profile of neonates with SCI through rotational thromboelastometry (ROTEM), a laboratory method that assesses the viscoelastic properties of blood. This is a single-centered prospective cohort study including a group of neonates with SCI (n = 21); the control group consisted of healthy neonates (n = 24). Demographics, clinical parameters, and laboratory data were recorded at the disease onset. Neonatal scores for the assessment of disease severity (Modified NEOMOD, nSOFA, and NeoBAT) were also calculated. ROTEM parameters of neonates with SCI were compared to those of healthy neonates. ROTEM parameters differed between neonates with SCI and healthy neonates, indicating a hypocoagulable profile of infected neonates. Specifically, neonates with SCI had significantly prolonged clotting time (CT) and clot formation time (CFT), as well as lower clot amplitude at 10 min (A10) and maximum clot firmness (MCF) when compared to healthy neonates (p values < 0.05), findings that remained consistent after adjusting for confounding factors such as gestational age, birth weight, and sex. In addition, a strong correlation was noted between ROTEM parameters and disease severity based on the modified NEOMOD, nSOFA, and NeoBAT scores. ROTEM parameters revealed a hypocoagulable profile in neonates during the early stages of SCI, which is also associated with disease severity. The results of this study highlight the need for monitoring of hemostatic status of this vulnerable group of patients and indicate that ROTEM analysis may have a role in the early detection of the hemostatic derangements associated with SCI in neonates, in order to ensure timely diagnosis and targeted therapeutic intervention.

Association of Preoperative Physical Fitness With Post-Esophagectomy Pneumonia in Older With Locally Advanced Esophageal Cancer: An Exploratory Prospective Study.

Currently, there is a lack of evidence of prehabilitation during neoadjuvant chemotherapy (NAC) to prevent pneumonia of older patients. This study aimed to investigate the association of preoperative physical fitness after NAC with post-esophagectomy pneumonia in older patients with locally advanced esophageal cancer (LAEC). This single-center exploratory prospective cohort study included 80 patients aged ≥ 65 years with LAEC scheduled for curative esophagectomy after NAC between 2021 and 2023. The post-NAC short incremental shuttle walk test (ISWT) by sex was established using the Youden index. The association of the post-NAC short ISWT with postoperative pneumonia was investigated via Firth's penalized logistic regression model with statistical significance set as two-tailed p < 0.05. A total of 69 patients were analyzed. The mean post-NAC ISWT values were 353.5 m. Short ISWT distance was defined as ≤ 395 and ≤ 195 m for men and women, respectively. Postoperative pneumonia developed in 17 (25%) patients. Short post-NAC ISWT distance was significantly associated with postoperative pneumonia (adjusted odds ratio: 1.840, 95%CI: 1.760-28.440, p = 0.004). Decline in physical fitness was associated with post-esophagectomy pneumonia, which may be a key targeted factor of prehabilitation during NAC for older patients with LAEC.

COMPARATIVE EVALUATION OF SURGICAL OUTCOMES IN NEONATES WITH CONGENITAL DIAPHRAGMATIC HERNIA TREATED BY LAPAROTOMY OR THORACOTOMY

The choice of surgical approach often depends on the experience of the surgeon and the specific clinical situation. The lack of consensus makes it difficult to compare outcomes between centers and hinders the establishment of a standard for high-risk CDH patients. Objective: to describe the structure and comparison of reoperation rates in children with congenital diaphragmatic hernia (CDH) based on surgical approach, to identify the major risk factors for reoperation, and to provide pathophysiologic rationale for the optimal surgical approach. Materials and Methods: This single-center prospective cohort study compares the outcomes of surgical correction of CDH by laparotomy (n=53) and thoracotomy (n=41). The study included a neonatal group of children with high-risk left-sided CDH who underwent surgery at Ohmatdyt Hospital between 2000 and 2024. Follow-up was at least one year. Clinical data were analyzed statistically. The mean (M) and standard deviation (SD), and the median (Me) and interquartile range (IQR) for metric data were calculated. Comparisons were made using the independent samples t-test with calculation of critical value (t) and statistical significance (p). For nominal data, the 2 criterion was used. The calculation of mortality risk included the assessment of absolute risks, their ratio (RR) with the determination of the error and 95% confidence interval. The analysis was performed with MS Excel and IBM SPSS Statistic 19. The study was conducted in accordance with the tenets of the Declaration of Helsinki. The study protocol was approved by the Local Ethics Committee (LEC) of all institutions mentioned in the paper. Informed consent for the study was obtained from the parents (or guardians) of the children. Results: The overall rate of surgical complications was higher in the laparotomy group (39.6% vs. 29.3%, p = 0.39), including the rate of reoperations (30.1% vs. 19.5%, p = 0.32) during the observation period. Complications such as adhesive and strangulation bowel obstruction and ventral hernia formation were more common in the laparotomy group. Recurrence and surgical treatment of GERD were almost equal (7.3% vs. 1.9%, p = 0.196). Early postoperative mortality was higher in the laparotomy group (32% vs. 17%, p=0.09). Conclusions: Postnatal treatment of CDH by laparotomy is associated with a higher incidence of surgical complications such as bowel obstruction and ventral hernia formation. Mortality was also more common in the laparotomy group. The use of thoracotomy as a surgical approach allows a pathogenetically justified correction of CDH by applying the developed concept of thoracalization of the abdominal cavity. This creates conditions for reducing the incidence of complications and improving the results of CDH repair.

Onco-mNGS facilitates rapid and precise identification of the etiology of fever of unknown origin: a single-centre prospective study in North China

ObjectivesDelayed diagnosis of patients with Fever of Unknown Origin has long been a daunting clinical challenge. Onco-mNGS, which can accurately diagnose infectious agents and identify suspected tumor signatures by analyzing host chromosome copy number changes, has been widely used to assist identifying complex etiologies. However, the application of Onco-mNGS to improve FUO etiological screening has never been studied before.MethodsIn this single-centre prospective study, we included 65 patients with classic FUO, who were randomly divided into control group (sample cultivation) and mNGS group (cultivation + Onco-mNGS). We analyzed the infectious agents and symbiotic microbiological, tumor and clinical data of both groups.ResultsInfection-related pathogenic detection efficiency rose from 25% (control group) to 48.48% (experimental group). Seven patients with chromosome copy number changes had later been confirmed tumors, indicating a 100% of clinical concordance rate of Onco-mNGS for tumors. In addition, the time frame for diagnosing or ruling out infection/tumor with Onco-mNGS had greatly reduced to approximately 2 days, which was 7.34 days earlier than that in the control group.ConclusionsOnco-mNGS is an ideal rapid diagnostic aid to assist improving the early diagnostic efficiency of FUO-associated diseases.

Early Improvement in Cardiac Function and Dyssynchrony After Physiological Upgrading in Pacing-Induced Cardiomyopathy.

Interventricular dyssynchrony derived from the classic non-physiological stimulation (n-PS) of the right ventricle (RV) is a known cause of left ventricular dysfunction (LVDys). This was a prospective descriptive single-center study. We analyzed patients who develop LVDys with n-PS, and the results after upgrading to conduction system pacing (CSP). Ultra-high frequency electrocardiogram (UHF-ECG) was performed pre and post-implantation of the last patients included. ECG recordings in 16 frequency bands (150-1000Hz) were used to create maps of ventricular depolarization. The maximum time difference between the centers of mass of the complex UHF QRS of leads V1-V6 (electrical dyssynchrony [DYS-e] 16) and V1-V8 (DYS-e 18) defined ventricular dyssynchrony. Data were expressed as mean ± standard deviation. 27 patients were upgraded to CSP from January 2022 to January 2024 after developing LVDys. Permanent His bundle pacing (p-HBP) was achieved in 63% (n=17); in the other 10 patients left bundle branch area pacing (LBBAp) was performed. The average baseline LVEF improved from 34.5% (27-42) to 47.6% (38.2-57), p < 0.001. Telediastolic left ventricle diameter as well as QRS width also decreased. Thresholds remained stable at 6-month follow-up. The last eight patients included were studied in terms of ventricular synchrony parameters by UHF-ECG (VDI Technologies), both His bundle pacing (HBP) and the LBBAp achieved significant improvement with respect to baseline parameters. LVEF improved in patients with previous n-PS-induced cardiomyopathy after upgrading to CSP. LVDys due to dyssynchronopathy is frequent and probably underdiagnosed. UHF-ECG provides useful new information about ventricular activation and will likely improve patient selection for cardiac resynchronization therapy (CRT).

Changes in gastrointestinal motility and gut hormone secretion after Roux-en-Y gastric bypass and sleeve gastrectomy for individuals with severe obesity.

Bariatric surgery is very effective in long-term weight management. The present study was undertaken to investigate the short-term effects of sleeve gastrectomy (SG) and of Roux-en-Y gastric bypass (RYGB) on (a) gastrointestinal (GI) motility, that is gastric emptying and oro-cecal transit time and (b) secretion of regulatory gut peptides and (c) their interrelationship. Prospective single-centre study in which we assessed gastric emptying, oro-cecal transit time and gut peptide release in 28 severely obese individuals before and 2, respectively, 12 months after bariatric surgery (either SG or RYGB). Plasma PYY, GLP-1, ghrelin, insulin and glucose levels were measured fasting and after intake of a solid standard 459 kcal meal at each occasion. Gastric emptying was measured by 13 C octanoic acid breath testing, and oro-cecal transit time was measured by lactulose H2 breath testing. Satiation was measured using VAS scores. After both RYGB and SG gastric emptying become significantly accelerated, and postprandial release of the distal gut peptides GLP-1 and PYY becomes significantly increased, pointing to ileal brake activation. Oro-cecal transit time becomes significantly accelerated after SG but not after RYGB. No significant correlations were observed between changes in distal gut peptide release, changes in GI motility and clinical parameters. Both SG and RYGB resulted in significant weight loss and significantly affected GI motility and PYY and GLP-1 secretion. Subtle differences between both procedures were found in effect on oro-cecal transit time and patterns of peptide secretion.

Discrimination of benign, atypical, and malignant peripheral nerve sheath tumours in neurofibromatosis type 1 – intraindividual comparison of positron emission computed tomography and diffusion-weighted magnetic resonance imaging

BackgroundTo intraindividually compare the diagnostic performance of positron emission computed tomography (F-18-FDG-PET/CT) and diffusion-weighted magnetic resonance imaging (DW-MRI) in a non-inferiority design for the discrimination of peripheral nerve sheath tumours as benign (BPNST), atypical (ANF), or malignant (MPNST) in patients with neurofibromatosis type 1 (NF1).ResultsIn this prospective single-centre study, thirty-four NF1 patients (18 male; 30 ± 11 years) underwent F-18-FDG-PET/CT and multi-b-value DW-MRI (11 b-values 0 – 800 s/mm²) at 3T. Sixty-six lesions corresponding to 39 BPNST, 11 ANF, and 16 MPNST were evaluated. Two radiologists independently assessed the maximum standardized uptake value (SUVmax) and mean and minimum apparent diffusion coefficient (ADCmean/min) as well as the ADC in areas of lowest signal intensity in each lesion (ADCdark). The AUCs of DW-MRI and F-18-FDG-PET/CT were compared to determine whether the ADC is non-inferior to SUVmax (non-inferiority margin equal to -10%). Follow-up of ≥ 24 months (BPNST) or histopathological evaluation (MPNST + ANF) served as diagnostic reference standard. Both SUVmax and ADC parameters demonstrated good diagnostic accuracy (AUCSUVmax 94.0%; AUCADCmean/min/dark 91.6% / 90.1% / 92.5%). However, non-inferiority could not be demonstrated for any of the three ADC parameters (lower limits of the confidence intervals of the difference between the AUC of ADCmean/min/dark and SUVmax -12.9% / -14.5% / -11.6%). Inter-rater reliability was excellent for both imaging techniques (Krippendorff’s alpha all > 0.94).ConclusionsBoth PET/CT-derived SUVmax and MRI-derived ADC allow sensitive and non-invasive differentiation of benign and (pre)-malignant peripheral nerve sheath tumours. Nevertheless, DW-MRI cannot be considered as non-inferior to F-18-FDG-PET/CT in this prospective single-centre study.

Prospective Voice Assessment After Thyroidectomy Without Recurrent Laryngeal Nerve Injury

Background: Thyroidectomy, a surgical procedure for thyroid disorders, is associated with postoperative voice changes, even in cases without recurrent laryngeal nerve (RLN) injury. Our study evaluates the prevalence and predictors of voice disorders in thyroidectomy patients without RLN injury. Methods: Our single-center prospective study at the University Hospital Center Zagreb included 243 patients, with pre- and postoperative voice evaluations using acoustic analysis and videostroboscopy. Logistic regression, chi-square, MANOVA, and non-parametric tests assessed the impact of surgical, sociodemographic, and lifestyle factors. Results: The study analyzed 243 participants (141 lobectomy, 102 total thyroidectomy). Postoperative voice disorders occurred in 200 patients (100 lobectomy, 100 total thyroidectomy); 43 (17.7%) experienced no voice disorders. Significant associations were observed for surgery type (χ2 = 29.88, p &lt; 0.001), with total thyroidectomy having higher risk, surgery duration (χ2 = 16.40, p &lt; 0.001), thyroid volume (χ2 = 4.24, p = 0.045), and BMI (χ2 = 8.97, p = 0.011). Gender and age showed no significant correlation. Acoustic parameters differed significantly, with lobectomy patients showing better intensity, jitter, and shimmer values across postoperative measurements. Logistic regression identified surgery type (Exp(B) = 16.533, p = 0.001) and thyroid volume (Exp(B) = 2.335, p = 0.023) as predictors of voice disorders, achieving 82.7% classification accuracy. Multivariate analysis confirmed gender and surgery duration as significant contributors. Surgery duration exceeding 90 min and enlarged thyroid volume negatively influenced outcomes. Significant acoustic differences were also linked to BMI categories, with obese participants exhibiting poorer parameters, particularly shimmer and jitter. Conclusions: Surgery type, thyroid volume, BMI, and surgery duration are most likely significant predictors of postoperative voice disorders.

Postoperative corneal remodeling after corneal allograft intrastromal ring segment (CAIRS) implantation for keratoconus: An OCT study.

To demonstrate corneal remodeling after corneal allograft intrastromal ring segment (CAIRS) with an anterior-segment optical coherence tomography (AS-OCT). A prospective observational single-center study. This observational study included keratoconus patients who underwent CAIRS implantation into a stromal tunnel. Topographical, refractive, and visual changes were obtained from the patient records. Epithelial thickness (ET), anterior stromal thickness (AST), allograft corneal ring thickness (ACRT), and posterior stromal thickness (PST) were measured on the first day and 1, 3, 6, and 12 months postoperatively using AS-OCT. The study included 35 eyes of 27 patients with advanced keratoconus. The mean keratometry decreased from 48.26 ± 4.78 D to 44.50 ± 4.42 D at 1-year postoperatively (P = 0.004), mean corrected distance visual acuity increased from 0.29 ± 0.18 to 0.70 ± 0.24 (P < 0.001), and spherical equivalent (SE) decreased from -6.94 ± 4.32 D to -1.44 ± 4.44 D (P < 0.001). The mean AST decreased by 17.39 ± 5.78 μm in the postoperative 1st month compared to 1st day after surgery (P = 0.040). No statistically significant variations were observed in AST after the first month. There was no statistically significant difference in the mean ET, ACRT, and PST measurements between follow-up times. Significant negative correlations were found between SE change and ET (r = -0.543, P = 0.023) and between K1 change and ACRT (r = -0.548, P = 0.008). CAIRS is an effective treatment method to improve visual acuity and keratometry measurements and does not cause significant changes in graft thickness or recipient corneal epithelial and stromal thicknesses during the 1-year follow-up period. The observed correlations between SE, keratometry, and corneal thickness suggest that epithelial and stromal remodeling play crucial roles in postoperative outcomes of CAIRS.

TYTOCARE™ home telemonitoring device after radical cystectomy to optimise postoperative outcomes.

To evaluate the role of the TYTOCARE™ telemedicine programme for home telemonitoring during the early postoperative period following radical cystectomy (RC) in a prospective single-centre study. The study included patients aged <80 years with internet access who underwent RC at our institution between March 2021 and August 2023. Upon discharge, patients were monitored at home using the TYTOCARE™ telemedicine system. Daily, patients completed a symptom questionnaire and recorded heart rate, body temperature, intestinal sounds, and urine output, and wound/ostomy evaluations via photos. Weekly televisits via the TYTOCARETM platform and app were scheduled, with additional controls as needed. After 30 days, patients assessed their satisfaction using a visual analogue scale (VAS; 0-100) and a Telemedicine Satisfaction Questionnaire (TSQ; 1-5) and any technical issues were documented. A control group of patients, who underwent RC in the same study period but who did not take part in a postoperative telemonitoring programme, was chosen for comparison, with analysis of demographics, peri-operative data, postoperative complications and hospital readmissions within 30 days after discharge. A total of 16 patients were included in the TYTOCARETM group, and 88 in the control group. The mean VAS satisfaction scores were 86.4 (patients) and 92.3 (healthcare providers). The mean TSQ score was 4.3, indicating high satisfaction. All TYTOCARETM patients reported they would use and recommend the device. Two patients encountered minor technical issues, which were easily resolved. The TYTOCARETM group had a shorter hospital stay (11 vs 14 days; P = 0.04) and fewer medical complications ( 2/16 vs 21/88; P = 0.02). No TYTOCARETM patients were readmitted within 30 days, compared to 20.4% in the control group. The TYTOCARETM telemonitoring programme seems to be feasible and highly adhered to by patients and caregivers, with reductions in length of hospital stay, medical complications and hospital readmissions within the first 30 days post-discharge.

The predictive value of heparin-binding protein for bacterial infections in patients with severe polytrauma.

Heparin-binding protein is an inflammatory factor with predictive value for sepsis and participates in the inflammatory response through antibacterial effects, chemotaxis, and increased vascular permeability. The role of heparin-binding protein in sepsis has been progressively demonstrated, but few studies have been conducted in the context of polytrauma combined with bacterial infections. This study aims to investigate the predictive value of heparin-binding protein for bacterial infections in patients with severe polytrauma. This is a prospective single-center study. Patients with polytrauma in the emergency intensive care unit were selected for the study, and plasma heparin-binding protein concentrations and other laboratory parameters were measured within 48 hours of admission to the hospital. A two-sample comparison and univariate logistic regression analysis investigated the relationship between heparin-binding protein and bacterial infection in polytrauma patients. A multifactor logistic regression model was constructed, and the ROC curve was plotted. Ninety-seven patients with polytrauma were included in the study, 43 with bacterial infection and 54 without infection. Heparin-binding protein was higher in the infected group than in the control group [(32.00±3.20) ng/mL vs. (18.52±1.33) ng/mL, P = 0.001]. Univariate logistic regression analysis shows that heparin-binding protein is related to bacterial infection (OR = 1.10, Z = 3.91, 95%CI:1.05~1.15, P = 0.001). Multivariate logistic regression equations showed that patients were 1.12 times more likely to have bacterial infections for each value of heparin-binding protein increase, holding neutrophils and Procalcitonin (PCT) constant. ROC analysis shows that heparin-binding protein combined with neutrophils and PCT has better predictive value for bacterial infection [AUC = 0.935, 95%CI:0.870~0.977]. Heparin-binding protein may predict bacterial infection in patients with severe polytrauma. Combining heparin-binding protein, PCT, and neutrophils may improve bacterial infection prediction.

Automatic MRI-TRUS Fusion Technique for Transperineal Biopsy Guidance: From Preoperative Planning to Intraoperative Navigation.

Targeted and systematic transperineal biopsy of lesions guided by magnetic resonance imaging (MRI) and transrectal ultrasonography (TRUS) fusion technique may optimize the biopsy procedure and enhance the detection of prostate cancer. We described the transperineal biopsy guided by an automatic MRI-TRUS fusion technique, and evaluated the accuracy and feasibility of this method in a prospective single-center study. The proposed method focuses on automating the delineation of prostate contours in both the MRI and TRUS images, the registration and fusion of MRI and TRUS images, the generation and visualiztion of the systematic biopsy cores in their corresponding locations within the 2D and the 3D views, as well as the computation and visualiztion of needle trajectories from preoperative planning to intraoperative navigation. A total of 76 patients with clinically suspected prostate cancer underwent systematic (SBx) and targeted (TBx) biopsies, all performed by a single urologist with more than 10 years of experience. The detection rates of prostate cancer (PCa) and clinically significant prostate cancer (csPCa) were recorded. We also measured preoperative registration time, duration of the overall surgical procedure, and postoperative complication rates within the first week following the surgery. Descriptive analyses were presented in this study. PCa was identified in 73.7% (56/76) of the subjects, while csPCa was identified in 61.8% (47/76). The preoperative registration time was 5.0 min (IQR: 4.4-6.0), while the overall surgery duration was 24.8 min (IQR: 23.2-27.2). Postoperatively, 12 patients experienced immediate hematuria, and one patient reported dysuria 1 day following surgery. The automatic MRI-TRUS fusion technique for transperineal biopsy is feasible and safe, with preoperative planning to intraoperative navigation it offering convenient and efficient preoperative preparation and surgical procedure.

The Assessment of the Effectiveness of Ultrasound and Near-Infrared Spectroscopy of the Lungs for the Differential Diagnosis of Transient Tachypnea of Newborns and Congenital Pneumonia in Children over 350 Weeks of Gestation. The Prospective Study

Background. The most common cause of respiratory disorders (RD) in the first hours after birth in children older than 35 weeks of gestation are transient tachypnea of the newborns (TTN) and early neonatal infection, in particular, congenital pneumonia (CP). However, in the first 4 hours of life, there are no reliable methods for diagnosing these diseases. The aim of the study is to evaluate the effectiveness of ultrasound (US) and near-infrared spectroscopy (NIRS) of the lungs for the differential diagnosis of TTN and CP in children older than 35 weeks of gestation. Methods. A prospective single-center cohort study based on the Yekaterinburg Clinical Perinatal Center. Newborns older than 35 weeks of gestation with the development of RD in the first 4 hours of life were included, the sample size was 200 children. Upon admission to NICU, he performed studies: US and NIRS of the lungs on the lateral and posterior surfaces of the chest on both sides. A comparative analysis of the score of lung US and NIRS indicators in patients with TTN and CP was carried out. Results. During the study and subsequent analysis of the results, it was revealed that the studied methods for the differential diagnosis of TTN and CP have sensitivity and specificity, respectively: only US of the lungs 75.9% and 57.0%; only lung NIRS 77.6% and 74.6%; US and lung NIRS 86.2% and 84.5% together, the area under the curve 0.898, 95% CI 0.854–0.943, р &lt; 0,001. There is also evidence that the pattern of consolidation in the lungs is significantly more often recorded by US at VP (р &lt; 0,001). Conclusion. The study showed that the combined usage of US and lung NIRS has high sensitivity and specificity for the differential diagnosis of TTN and CP and is a promising method for early diagnosis of these diseases.

Protocol for evaluating physiological and psychological acclimatization mechanisms in Tibetan plateau environment: a clinical study of doctors from Peking Union Medical College Hospital.

The transition from low to high altitude environments is associated with a multifaceted series of physiological and psychological alterations that manifest over time. These changes are intricately intertwined, with physiological acclimatization primarily mediated through the regulation of hypoxia-inducible factor (HIF), which orchestrates the expression of critical molecules and hormones. This process extends to encompass the epigenome, metabolism, and other regulatory mechanisms. In the realm of psychological acclimatization, chronic hypoxia and changes in atmospheric pressure at high altitudes may contribute to decreased levels of neurotransmitters, with potential implications for mental health, particularly in relation to sleep quality. Despite significant advancements in our understanding of plateau acclimatization mechanisms in recent years, there remain many uncertain factors that necessitate further research. This study is a single-center prospective observational study. It aims to utilize a series of physiological and medical instruments in conjunction with internationally recognized physiological and psychological questionnaires to monitor the dynamic shifts in the acclimatization ability of doctors from Peking Union Medical College Hospital. The monitoring will occur at seven distinct time points: pre-departure from Beijing, 1-7 days post-arrival at the Tibetan plateau during the acute phase of plateau hypoxic stress, and during the chronic phase of plateau hypoxic stress at 2 weeks, 3 months, 6 months, 12 months of residency in Tibet, and post-return to Beijing. Concurrently, a spectrum of omics analyses will be conducted, including comprehensive genomic, proteomic, and metabolomic assessments of blood leukocytes, fecal, and oral samples.

Visibility of mpMRI region of interest on ultrasound during cognitive fusion targeted biopsy predicts prostate cancer detection: a prospective single-center study.

The purpose of this study was to evaluate the nature of ultrasound characteristics during mpMRI/TRUS cognitive fusion targeted biopsy (cTB). From 2023 to 2024, data from 502 lesions in 426 men who underwent targeted combined systematic biopsy were analyzed. All lesions had a Prostate Imaging Reporting and Data System (PI-RADS) score of ≥ 3. The primary endpoint was the detection rate of prostate cancer (PCa) according to the PI-RADS score/ultrasound characteristics, categorized as benign or invisible (Bi), hypoechoic only (Ho), and hypoechoic with microcalcification (Hm), assessed through cross-stratification. The secondary endpoints included the distribution of ultrasound characteristics across PI-RADS scores, prostate zones, and histological types. Finally, associations between ultrasound characteristics and clinically significant PCa (csPCa) were assessed using multivariate logistic regression analysis (MVA). Among lesions, 233 (46%) were Bi, 210 (42%) Ho, and 59 (12%) Hm. First, Bi lesions had a 64% (103/161) non-cancer rate in PI-RADS 3, while Ho + Hm lesions showed the highest csPCa rate in PI-RADS 5 at 82% (102/124). Additionally, Ho + Hm lesions were predominantly observed in PI-RADS 5 (92% [114/124]) and in the peripheral zone (64% [179/278]). Notably, Hm lesions had a significantly higher percentage of cribriform morphology than Ho lesions (32% vs. 14%, P = 0.001). Finally, MVA confirmed Ho ([Ref Bi] OR 4.95, P < 0.001) and Hm ([Ref Bi] OR 27.7, P < 0.001) as independent predictors of csPCa. In cTB, the identification of Ho and Hm lesions on TRUS enhances the diagnostic yield of csPCa by facilitating more precise localization compared to Bi lesions. No. 2023-272-002, July 14, 2023.

Correlation of the KRAS gene’s copy number variation and the results of targeted therapy for colorectal cancer

BACKGROUND: to find predictive value of KRAS gene’s copy number variation (CNV_KRAS) to anti-EGFR therapy.PATIENTS AND METHODS: a prospective cohort single-center study included 150 patients, 103 patients with colorectal cancer (CRC) and wild-type RAS/BRAF, 39 patients with colorectal cancer with somatic mutations in the KRAS gene, as well as 8 non-oncological patients (as normal controls). CNV_KRAS was determined using digital droplet PCR.RESULTS: the clinically significant CNV_KRAS level of ≥ 9 copies established for a refusal of targeted anti-EGFR therapy. The incidence of clinically significant CNV_KRAS level in patients with wild-type RAS/BRAF was 17% (the first group of patients). Incidence of clinically significant CNV_KRAS level in patients with mutations in the KRAS gene was 3% (the second group of patients). At the I stage of CRC clinically significant CNV_KRAS was not detected in either the first or second group; at the stage II of CRC in the first group — in 14% of patients (3/22), and in the second group — not detected; at the stage III of CRC in the first group — in 21% of patients (8/39), and in the second group of patients — not detected; at the stage IV of CRC in the first group — in 17% (6/35) of patients, and in the second group of patients — in 5% (1/20). Tumor DNA was analyzed in 10 patients with the stage IV CRC from the first group who received anti-EGFR therapy to find out the clinically significant level of CNV_KRAS. Disease control was achieved in 7 out of 10 patients. The median CNV_KRAS score in the remaining three patients was higher than in the disease control group, 9.2 (9.05, 10.10) and 5.38 (4.77, 7.35) (p = 0.017).CONCLUSIONS: detection of CNV_KRAS level of ≥ 9 copies in a malignant colon tumor is a contraindication to targeted therapy. This phenomenon occurs significantly more often in patients without somatic mutations in the RAS genes (KRAS, NRAS) and BRAF, than in patients with point mutations in the KRAS gene (p = 0.02).

Loose seton in the treatment of transsphincteric anal fistulas complicated by additional fistula tracks (randomized trial)

AIM: to evaluate caudal migration of free seton in patients with anal fistulas complicated by additional fistula tracks.PATIENTS AND METHODS: the prospective randomized single-center study included 115 patients with transshincteric fistulas, who had one of 2 types of seton installed. The decision to choose a seton was made by randomization in 2 groups: 63 patients with a polyester braided ribbon with a fluoropolymer coating 3 mm wide (Polyester-F Braid 3 mm, “Balumed” LLC, Russian Federation) seton “T”, and the 2nd group included 52 patients with a seton polyester braided ribbon with a fluoropolymer coating with a diameter of 0.5 mm of USP conditional number 2 with a diameter of 0.5 mm was installed (Polyester-F Thread USP 2 with a diameter of 0.5 mm, “Balumed” LLC, Russian Federation) — seton “N”.RESULTS: after 12 weeks the largest number of complete caudal migration occurred in 30/63 (47.6%; 95% CI: 34.9–60.6) patients with seton “T”, whereas in patients with seton “N” it occurred significantly less often in 7/52 (13.5%; 95% CI: 5.6–25.8) patients (p = 0.0002). Caudal seton migration with sphincter involvement of more than 1/2 was noted only in 1 patient with seton “T”, and was completely absent in patients with seton “N”.CONCLUSION: in patients with a fistulas involving less than 1/2 of the external sphincter, it is reasonable to use a 3 mm wide fluoropolymer-coated polyester braided band as a seton, expecting caudal migration in almost half of the cases. Whereas the installation of a 0.5-mm diameter fluoropolymer-coated polyester braided thread, when more than 1/2 of the external sphincter is involved, does not lead to caudal migration.

Tracing carriage, acquisition, and transmission of ESBL-producing Escherichia coli over two years in a tertiary care hospital

BackgroundThe impact of community carriage on the influx of extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-E) into hospitals remains understudied. In this prospective 2-year single-centre study, we investigate the community ESBL-E influx and trace the colonisation, nosocomial acquisition, transmission, and infection dynamics of ESBL-producing Escherichia coli (ESBL-Ec) in non-ICU wards at a tertiary care hospital.MethodsThis study reports primary and post hoc outcomes of the clinical trial NCT01208519 in which hospitalised patients were screened for rectal carriage of ESBL-E. ESBL-Ec isolates from ≈50% of carriers, including all patients who developed infections, were sequenced and genotyped. Endogenous infection was defined as infection by the same strain (< 10 SNPs distance) as colonizing strain.ResultsOf 3703 screened patients, 456 (12.3%) were ESBL-positive-at-admission (PA-ESBL). Of the 2268 ESBL-negative-at-admission (NA-ESBL) patients with follow-up samples, 240 (10.6%) acquired ESBL-E (HA-ESBL), with an incidence density rate of 7.96 cases/1000 patient-day, notably higher in patients receiving antibiotics (P < 0.001). PA- and HA-ESBL patients developed significantly more ESBL-E infections than ESBL-free patients (P < 0.001). Sequenced ESBL-Ec showed high clonal diversity dominated by the multidrug-resistant and highly virulent ST131 clade, C2/H30-Rx. Among ESBL-Ec infections, 60% (18/30) were endogenous. Direct between-patients transmission clusters (n = 21) involved 23.9% (48/201) of patients and 23.0% (84/366) of ESBL-Ec isolates.ConclusionsOur data show a high prevalence of nosocomial acquisition of ESBL-E in a non-ICU setting. The study provides genomic evidence that the endogenous reservoir is the main driver of ESBL-Ec infections underscoring the need for wide implementation of antibiotic stewardship programmes to reduce antibiotic pressure.

Risk factors and prediction model of breast cancer-related lymphoedema in a Chinese cancer centre: a prospective cohort study protocol

IntroductionLymphoedema is a distressing and long-term complication for breast cancer survivors. However, the reported incidence of lymphoedema varies, and its risk factors remain underexplored. Currently, a well-established risk prediction model...

Intraoperative Electroencephalogram Frontal Low Alpha Power for Predicting Postoperative Delirium in Elderly Patients after Orthopedic Surgery: A Prospective Cohort Study.

Postoperative delirium (POD) is a common complication with significant adverse effects in elderly patients. Electroencephalography (EEG) provides a promising approach for predicting the risk of POD. This study aims to elucidate the correlation between intraoperative EEG spectrum and the incidence of POD in elderly patients undergoing orthopedic surgery. A single-center prospective observational cohort study was conducted at Zhongda Hospital, Southeast University, from September 2022 to March 2023, registered on Chinese Clinical Trail Registry (ChiCTR2300069548). Among the 172 patients who underwent orthopedic surgery, 125 completed the study with available data. Preoperative baseline cognitive function was assessed using the mini-mental state examination (MMSE). An intraoperative 4-channel EEG was recorded. Total power spectra and power spectral density for beta, alpha, theta, and delta bands were calculated. Spectral edge frequency, burst suppression ratio, and patient state index were directly extracted from the EEG monitor. The primary outcome was POD, assessed using a 3-minute Diagnostic Interview for Confusion Assessment Method (CAM)-Defined Delirium scale or the CAM for the Intensive Care Unit. Patients were divided into POD and non-postoperative delirium (non-POD) groups. Logistic regression analysis was conducted to evaluate the independent predictive effect of intraoperative spectral distribution and other quantitative EEG data for POD. The incidence of delirium within 72 hours after surgery was 8.8%. Compared to the non-POD group, the POD group showed significantly lower absolute power in the beta [0.06 (0.03, 0.09) dB vs 0.14 (0.08, 0.26) dB, p < 0.001], alpha [0.41 (0.25, 0.71) dB vs 1.24 (0.55, 2.57) dB, p = 0.008], and theta [0.77 (0.44, 1.01) dB vs 1.19 (0.72, 2.02) dB, p = 0.035] bands. Logistic regression analysis identified several independent risk factors for POD, including lower intraoperative alpha power [odds ratio (OR) 10.210, 95% confidence interval (CI) 1.233-84.568, p = 0.031], advanced age (OR 7.713, 95% CI 1.022-58.204, p = 0.048), preoperative anemia (OR 6.636, 95% CI 1.091-40.358, p = 0.040), and preoperative depression (OR 10.089, 95% CI 1.029-98.909, p = 0.047). In contrast, higher preoperative MMSE scores appeared to be a protective factor for POD (OR 0.130, 95% CI 0.021-0.820, p = 0.030). Intraoperative EEG frontal low alpha power demonstrated a significant independent association with POD in elderly patients after orthopedic surgery. This parameter may serve as an intraoperative neurophysiological marker of cerebral vulnerability to POD. Additionally, advanced age, lower preoperative MMSE scores, preoperative anemia, and preoperative depression were independent risk factors for POD. Chinese Clinical Trial Registry (ChiCTR2300069548).