Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 269
Filter
1.
Burns ; 2024 Mar 15.
Article in English | MEDLINE | ID: mdl-38641499

ABSTRACT

BACKGROUND: The purpose of dermal substitutes is to mimic the basic properties of the extracellular matrix of human skin. The application of dermal substitutes to the defect reduces the formation of hypertrophic scars and improves the scar quality. This study aims to develop an original dermal substitute enriched with stable fibroblast growth factor 2 (FGF2-STAB®) and test it in an animal model. METHODS: Dermal substitutes based on collagen/chitosan scaffolds or collagen/chitosan scaffolds with nanofibrous layer were prepared and enriched with FGF2-STAB® at concentrations of 0, 0.1, 1.0, and 10.0 µg ‧ cm-2. The performance of these dermal substitutes was tested in vivo on artificially formed skin defects in female swine. The outcomes were evaluated using cutometry at 3 and 6 months. In addition, visual appearance was assessed based on photos of the scars at 1-month, 3-month and 6-month follow-ups using Yeong scale and Visual Analog Scale. RESULTS: The dermal substitute was fully integrated into all defects and all wounds healed successfully. FGF2-STAB®-enriched matrices yielded better results in cutometry compared to scaffolds without FGF2. Visual evaluation at 1, 3, and 6 months follow-ups detected no significant differences among groups. The FGF2-STAB® effectiveness in improving the elasticity of scar tissues was confirmed in the swine model. This effect was independently observed in the scaffolds with nanofibres as well as in the scaffolds without nanofibres. CONCLUSION: The formation of scars with the best elasticity was exhibited by addition 1.0 µg ‧ cm-2of FGF2-STAB® into the scaffolds, although it had no significant effect on visual appearance at longer follow-ups. This study creates the basis for further translational studies of the developed product and its progression into the clinical phase of the research.

2.
Front Pediatr ; 12: 1314184, 2024.
Article in English | MEDLINE | ID: mdl-38425661

ABSTRACT

Background: Retraction pocket (RP) of the tympanic membrane (TM) is a common pathology in children that can cause ossicular chain erosion, cholesteatoma formation, and potentially life-threatening complications of cholesteatoma. This study assessed the functional and anatomical results of cartilage grafting in children with severe RP of the TM. Methods: This was a retrospective review of 212 children from a tertiary referral center. Results: We identified significant differences in hearing results, indication criteria, and location of TM fixation between stages II and III of RP (according to Charachon). We observed a significantly higher incidence of RP in boys than in girls. Conclusions: Cartilage tympanoplasty for retraction pocket of the tympanic membrane in children is a safe procedure with good anatomical and hearing results.

4.
Hellenic J Cardiol ; 76: 1-10, 2024.
Article in English | MEDLINE | ID: mdl-37633488

ABSTRACT

INTRODUCTION AND OBJECTIVES: Multivessel primary percutaneous coronary intervention (pPCI) is still often used in patients with ST-elevation myocardial infarction (STEMI) and cardiogenic shock (CS). The study aimed to compare the characteristics and prognosis of patients with CS-STEMI and multivessel coronary disease (MVD) treated with culprit vessel-only pPCI or multivessel-pPCI during the initial procedure. MATERIAL AND METHODS: From 2016 to 2020, 23,703 primary PCI patients with STEMI were included in a national all-comers registry of cardiovascular interventions. Of them, 1,213 (5.1%) patients had CS and MVD at admission to the hospital. Initially, 921 (75.9%) patients were treated with culprit vessel (CV)-pPCI and 292 (24.1%) with multivessel (MV)-pPCI. RESULTS: Patients with 3-vessel disease and left main disease had a higher probability of being treated with MV-pPCI than patients with 2-vessel disease and patients without left main disease (28.5% vs. 18.6%; p < 0.001 and 37.7% vs. 20.6%; p < 0.001). Intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), and other mechanical circulatory support systems were more often used in patients with MV-pPCI. Thirty (30)-day and 1-year all-cause mortality rates were similar in the CV-pPCI and MV-pPCI groups (odds ratio, 1.01; 95% confidence interval [CI] 0.77 to 1.32; p = 0.937 and 1.1; 95% CI 0.84 to 1.44; p = 0.477). The presence of 3-vessel disease and the use of ECMO were the strongest adjusted predictors of 30-day and 1-year mortality. CONCLUSIONS: Our data from an extensive all-comers registry suggests that selective use of MV-pPCI does not increase the all-cause mortality rate in patients with CS-STEMI and MVD compared to CV-pPCI.


Subject(s)
Coronary Artery Disease , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , Coronary Artery Disease/complications , Coronary Artery Disease/surgery , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/surgery , Treatment Outcome , Risk Factors , Myocardial Infarction/complications , Myocardial Infarction/therapy
5.
World J Surg Oncol ; 21(1): 384, 2023 Dec 14.
Article in English | MEDLINE | ID: mdl-38098074

ABSTRACT

BACKGROUND: The aim of this prospective study was to evaluate the role of serum IL-6 as a potential predictive biomarker of postoperative complications (POC) in elective colorectal surgery. METHOD: A total of 115 patients underwent colorectal surgery for malignancy. IL-6 was measured on the first and third postoperative days (POD1, POD3), and C-reactive protein (CRP) was measured on the POD3. POC was analysed in subgroups according to Clavien‒Dindo (CD), antibiotic (ATB) treatment, intensive care unit (ICU) and hospital length of stay. The predictive power of variables for evaluated endpoints was analysed using receiver-operating characteristic (ROC) analysis and described by area under the curve (AUC). ROC analysis was adopted for the identification of optimal cut-offs. Histological analysis was performed to verify IL-6 production by the tumour. RESULTS: Out of 115 patients who were analysed, 42% had POC. Patients with POC had significantly higher serum levels of IL-6 on POD1 (p < 0.001) and POD3 (p < 0.001). IL-6 early on POD1 as a predictor of antibiotic treatment, ICU stay and hospital stay (AUC 0.818; 0.811; 0.771) did not significantly differ from the AUC of CRP late on POD3 (0.879; 0.838, 0.752). A cut-off IL-6 value of 113 pg/ml on POD1 and 180.5 pg/ml on POD3 in severe complications (CD > 3a) resulted in 75% and 72% sensitivity, 78.6% and 99% specificity, negative predictive value 96.4% and 97% and positive predictive value 29% and 88.9%. CONCLUSION: The serum level of interleukin-6 can predict severe (CD > 3a) POC early on POD1. On POD3, IL-6 is superior to CRP in terms of high positive predictive power of severe POC. Interestingly, the advantage of IL-6 on POD1 is early prediction of the need for antibiotic treatment, ICU stay and hospital stay, which is comparable to the CRP serum level late on the third POD.


Subject(s)
Colorectal Surgery , Interleukin-6 , Humans , Anti-Bacterial Agents , Biomarkers , C-Reactive Protein/analysis , Postoperative Complications/etiology , Prospective Studies , ROC Curve
6.
Front Cardiovasc Med ; 10: 1248145, 2023.
Article in English | MEDLINE | ID: mdl-38144370

ABSTRACT

Background and aims: Analysis of mortality from the national health registries and data from a specific central registry dealing with the implantation of pacemakers (REPACE) in Czech patients. Methods and results: Retrospective observational analysis of pacemakers' implantation in all Czech patients [n = 82,791; 47,070 (56.9%) men, 75.9 ± 10.4 years old] between 2010 and 2021. Almost 114,000 pacemakers were implanted between 2010 and 2021, of which 27.9% were single-chamber, 67.4% were dual-chamber and 4.6% were biventricular. The annual number of implantations has been steadily increasing with a 6% annual decline in 2020 with increased mortality and reductions in care provided, likely related to COVID-19. The observed 5-year relative survival was 88.6% (overall survival 60.6%) and the 10-year relative survival was 75.9% (overall survival 32.7%). Causes of death 5ary according to the age of the patient. The highest difference 1n the reported numbers in the REPACE Registry did not exceed 2% in comparison with the National Register of Reimbursed Health Services. Conclusion: This study followed all Czech patients with pacemaker's implantation in between 2010 and 2021. The annual number of 1mplantations has been steadily 1ncreasing. Patients with implanted pacemakers had a significantly higher mortality than the average population. Number of patients in the registry corresponded almost perfectly with the National Register of Reimbursed Health Services.

7.
Int J Chron Obstruct Pulmon Dis ; 18: 2661-2672, 2023.
Article in English | MEDLINE | ID: mdl-38022829

ABSTRACT

Purpose: The Phenotypes of COPD in Central and Eastern Europe (POPE) study assessed the prevalence and clinical characteristics of four clinical COPD phenotypes, but not mortality. This retrospective analysis of the POPE study (RETRO-POPE) investigated the relationship between all-cause mortality and patient characteristics using two grouping methods: clinical phenotyping (as in POPE) and Burgel clustering, to better identify high-risk patients. Patients and Methods: The two largest POPE study patient cohorts (Czech Republic and Serbia) were categorized into one of four clinical phenotypes (acute exacerbators [with/without chronic bronchitis], non-exacerbators, asthma-COPD overlap), and one of five Burgel clusters based on comorbidities, lung function, age, body mass index (BMI) and dyspnea (very severe comorbid, very severe respiratory, moderate-to-severe respiratory, moderate-to-severe comorbid/obese, and mild respiratory). Patients were followed-up for approximately 7 years for survival status. Results: Overall, 801 of 1,003 screened patients had sufficient data for analysis. Of these, 440 patients (54.9%) were alive and 361 (45.1%) had died at the end of follow-up. Analysis of survival by clinical phenotype showed no significant differences between the phenotypes (P=0.211). However, Burgel clustering demonstrated significant differences in survival between clusters (P<0.001), with patients in the "very severe comorbid" and "very severe respiratory" clusters most likely to die. Overall survival was not significantly different between Serbia and the Czech Republic after adjustment for age, BMI, comorbidities and forced expiratory volume in 1 second (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.65-0.99; P=0.036 [unadjusted]; HR 0.88, 95% CI 0.7-1.1; P=0.257 [adjusted]). The most common causes of death were respiratory-related (36.8%), followed by cardiovascular (25.2%) then neoplasm (15.2%). Conclusion: Patient clusters based on comorbidities, lung function, age, BMI and dyspnea were more likely to show differences in COPD mortality risk than phenotypes defined by exacerbation history and presence/absence of chronic bronchitis and/or asthmatic features.


Subject(s)
Bronchitis, Chronic , Pulmonary Disease, Chronic Obstructive , Humans , Pulmonary Disease, Chronic Obstructive/epidemiology , Retrospective Studies , Forced Expiratory Volume , Dyspnea/epidemiology , Phenotype , Disease Progression
8.
Vet Med (Praha) ; 68(4): 145-151, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37982086

ABSTRACT

The aim of the study was to compare the efficacy of the intranasal and parenteral administration of azaperone in order to achieve pig sedation. A total of 32 weaned piglets divided into 4 groups (8 piglets in each group) were used. Group A was injected intramuscularly (i.m.) with azaperone (Stresnil®, 40 mg/ml inj.; Elanco Animal Health) at a dose of 2 mg/kg of body weight (b.w.). Group B received a dose of 2 mg/kg b.w. of azaperone intranasally. Group C was given azaperone intranasally at a dose of 4 mg/kg b.w. Group D was given 1 ml of saline intranasally and served as the control group. The response to the defined stimulus (a blunt blow of a metal rod into a metal edge of a pen), the degree of salivation, movement level, body temperature and serum azaperone concentration were included in the trial. We found that in order to induce an adequate level of sedation comparable to the standard method of application, i.e., 2 mg/kg b.w. i.m., the intranasal administration of azaperone at a dose of 4 mg/kg body weight is required.

9.
J Wound Care ; 32(9): 579-586, 2023 Sep 02.
Article in English | MEDLINE | ID: mdl-37682788

ABSTRACT

OBJECTIVE: Pressure ulcers (PUs) are a significant healthcare problem with a negative impact on patients' quality of life and incurring substantial healthcare expenses. Our study aimed to analyse the costs of treating PUs in hospitalised patients in the Czech Republic, in the context of current treatment procedures and price levels, and to pilot-test the detailed methodology developed. METHOD: A prospective, observational, non-interventional study was conducted at the Clinic of Anesthesiology, Resuscitation and Intensive Medicine, the Internal Medicine Department and the Surgical Department of the University Hospital Ostrava. The study included all hospitalised patients with a PU from March-May 2021. Data were collected using the hospital information system. A bottom-up, person-based approach to cost analysis was used, based on a comprehensive cost structure using accurate patient-specific consumption records. RESULTS: The length of hospitalisations ranged from 1-31 (mean: 12.7) days. The average cost of PU treatment per hospitalisation was calculated at €1579. The average daily cost of PU treatment was €179, including antibiotic therapy (ATB) and €112 without ATB. Most of the costs were associated with ATB (38.6%) and caregivers' time (35.9%). Based on the results, a predictive model was developed to estimate the cost of treating a hospitalised patient with a PU, which could be used in future research to assess the costs of treating these patients. CONCLUSION: We have faced many challenges in the methodology of preparation of cost analysis (e.g., how to count amorphous topical agents and sprays, how to properly identify PUs, how to price the positioning aids and mattresses, and how to relate the ATB treatment to the PU). This analysis provides important input for developing a comprehensive and more accurate methodology for monitoring PU costs in hospitalised patients, applicable in clinical practice for inpatient healthcare providers.


Subject(s)
Pressure Ulcer , Humans , Prospective Studies , Pressure Ulcer/therapy , Quality of Life , Ambulatory Care Facilities , Suppuration
11.
Euro Surveill ; 28(38)2023 09.
Article in English | MEDLINE | ID: mdl-37733239

ABSTRACT

BackgroundThe sensitivity and specificity of selected antigen detection rapid diagnostic tests (AG-RDTs) for SARS-CoV-2 were determined in the unvaccinated population when the Delta variant was circulating. Viral loads, dynamics, symptoms and tissue tropism differ between Omicron and Delta.AimWe aimed to compare AG-RDT sensitivity and specificity in selected subgroups during Omicron vs Delta circulation.MethodsWe retrospectively paired AG-RDT results with PCRs registered in Czechia's Information System for Infectious Diseases from 1 to 25 December 2021 (Delta, n = 20,121) and 20 January to 24 February 2022 (Omicron, n = 47,104).ResultsWhen confirmatory PCR was conducted on the same day as AG-RDT as a proxy for antigen testing close to peak viral load, the average sensitivity for Delta was 80.4% and for Omicron 81.4% (p < 0.05). Sensitivity in vaccinated individuals was lower for Omicron (OR = 0.94; 95% confidence interval (CI): 0.87-1.03), particularly in reinfections (OR = 0.83; 95% CI: 0.75-0.92). Saliva AG-RDT sensitivity was below average for both Delta (74.4%) and Omicron (78.4%). Tests on the European Union Category A list had higher sensitivity than tests in Category B. The highest sensitivity for Omicron (88.5%) was recorded for patients with loss of smell or taste, however, these symptoms were almost 10-fold less common than for Delta. The sensitivity of AG-RDTs performed on initially asymptomatic individuals done 1, 2 or 3 days before a positive PCR test was consistently lower for Omicron compared with Delta.ConclusionSensitivity for Omicron was lower in subgroups that may become more common if SARS-CoV-2 becomes an endemic virus.


Subject(s)
COVID-19 , Humans , COVID-19/diagnosis , Czech Republic/epidemiology , SARS-CoV-2/genetics , Retrospective Studies , Reinfection , COVID-19 Testing
12.
J Cardiovasc Electrophysiol ; 34(9): 1885-1895, 2023 09.
Article in English | MEDLINE | ID: mdl-37529864

ABSTRACT

INTRODUCTION: Observational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). METHODS: The Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). RESULTS: The trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. CONCLUSION: During the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Humans , Anticoagulants/adverse effects , Stroke/diagnosis , Stroke/etiology , Stroke/prevention & control , Atrial Appendage/surgery , Prospective Studies , Treatment Outcome , Hemorrhage/chemically induced , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy
13.
Trials ; 24(1): 539, 2023 Aug 17.
Article in English | MEDLINE | ID: mdl-37587489

ABSTRACT

BACKGROUND: Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients' compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients. OBJECTIVES: The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients. METHODS: The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period. DISCUSSION: The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients' recruitment and impacted their physical activity patterns. CONCLUSIONS: The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).


Subject(s)
COVID-19 , Heart Failure , Humans , Actigraphy , Pandemics , Walking , Heart Failure/diagnosis , Heart Failure/therapy
14.
PLoS One ; 18(7): e0287959, 2023.
Article in English | MEDLINE | ID: mdl-37440522

ABSTRACT

We present a novel approach to estimate the time-varying ascertainment rate in almost real-time, based on the surveillance of positively tested infectious and hospital admission data. We also address the age dependence of the estimate. The ascertainment rate estimation is based on the Bayes theorem. It can be easily calculated and used (i) as part of a mechanistic model of the disease spread or (ii) to estimate the unreported infections or changes in their proportion in almost real-time as one of the early-warning signals in case of undetected outbreak emergence. The paper also contains a case study of the COVID-19 epidemic in the Czech Republic. The case study demonstrates the usage of the ascertainment rate estimate in retrospective analysis, epidemic monitoring, explanations of differences between waves, usage in the national Anti-epidemic system, and monitoring of the effectiveness of non-pharmaceutical interventions on Czech nationwide surveillance datasets. The Czech data reveal that the probability of hospitalization due to SARS-CoV-2 infection for the senior population was 12 times higher than for the non-senior population in the monitored period from the beginning of March 2020 to the end of May 2021. In a mechanistic model of COVID-19 spread in the Czech Republic, the ascertainment rate enables us to explain the links between all basic compartments, including new cases, hospitalizations, and deaths.


Subject(s)
COVID-19 , Communicable Diseases , Humans , COVID-19/epidemiology , Czech Republic/epidemiology , SARS-CoV-2 , Bayes Theorem , Retrospective Studies , Hospitalization
15.
J Tissue Viability ; 32(3): 365-370, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37198049

ABSTRACT

BACKGROUND: Pressure ulcers/pressure injuries (PUs/PIs) relate to decreasing quality of life, prolonged hospitalisation, the increased economic cost of care, and increased mortality. That's why this study focused on one of the mentioned factors - mortality. OBJECTIVES: The study analyses national data in the Czech Republic to map the mortality phenomenon comprehensively based on data from national health registries. METHOD: The retrospective, nationwide cross-sectional data analysis of data collected by the National Health Information System (NHIS) has been provided in the period 2010-2019 with a special focus on 2019. Hospitalisations with PUs/PIs were identified by reporting L89.0-L89.9 diagnosis as a primary or secondary hospitalisation diagnosis. We also included all the patients who died in the given year with an L89 diagnosis reported in 365 days prior the death. RESULTS: In 2019, 52.1% of patients with reported PUs/PIs were hospitalised, and 40.8% were treated on an outpatient basis. The most common underlying cause of death mortality diagnosis (43.7%) in these patients was the diseases of the circulatory system. Patients who die in a healthcare facility while hospitalised with an L89 diagnosis generally have a higher category of PUs/PIs than persons who die outside a healthcare facility. CONCLUSION: The proportion of patients dying in a health facility is directly proportional to the increasing PUs/PIs category. In 2019, 57% of patients with PUs/PIs died in a healthcare facility, and 19% died in the community. In 24% of patients who died in the healthcare facility, PUs/PIs were reported 365 days before the death.


Subject(s)
Pressure Ulcer , Humans , Retrospective Studies , Pressure Ulcer/epidemiology , Czech Republic/epidemiology , Cross-Sectional Studies , Quality of Life , Suppuration
17.
J Nanobiotechnology ; 21(1): 80, 2023 Mar 07.
Article in English | MEDLINE | ID: mdl-36882867

ABSTRACT

Treatment of complete loss of skin thickness requires expensive cellular materials and limited skin grafts used as temporary coverage. This paper presents an acellular bilayer scaffold modified with polydopamine (PDA), which is designed to mimic a missing dermis and a basement membrane (BM). The alternate dermis is made from freeze-dried collagen and chitosan (Coll/Chit) or collagen and a calcium salt of oxidized cellulose (Coll/CaOC). Alternate BM is made from electrospun gelatin (Gel), polycaprolactone (PCL), and CaOC. Morphological and mechanical analyzes have shown that PDA significantly improved the elasticity and strength of collagen microfibrils, which favorably affected swelling capacity and porosity. PDA significantly supported and maintained metabolic activity, proliferation, and viability of the murine fibroblast cell lines. The in vivo experiment carried out in a domestic Large white pig model resulted in the expression of pro-inflammatory cytokines in the first 1-2 weeks, giving the idea that PDA and/or CaOC trigger the early stages of inflammation. Otherwise, in later stages, PDA caused a reduction in inflammation with the expression of the anti-inflammatory molecule IL10 and the transforming growth factor ß (TGFß1), which could support the formation of fibroblasts. Similarities in treatment with native porcine skin suggested that the bilayer can be used as an implant for full-thickness skin wounds and thus eliminate the use of skin grafts.


Subject(s)
Nanofibers , Swine , Animals , Mice , Osmium Compounds , Inflammation
18.
Urogynecology (Phila) ; 29(2): 113-120, 2023 02 01.
Article in English | MEDLINE | ID: mdl-36735422

ABSTRACT

IMPORTANCE: This study compares the long-term efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator tape (TOT) sling in the treatment of female stress urinary incontinence. OBJECTIVES: Women with urodynamic stress urinary incontinence were randomized to either SIS or TOT groups and followed up for 4 years. The primary outcome was objective cure defined with a negative cough stress test result. Secondary outcomes involved subjective cure reported via patient's satisfaction scale, surgery complications, postoperative de novo urgency, and patient's life quality. STUDY DESIGN: This is a randomized noninferiority controlled trial. RESULTS: A total of 168 women were randomized (84 in both groups). After 4-year follow-up, 130 patients were analyzed (66 in the SIS group and 64 in the TOT group). The objective (86.4% vs 84.4%; risk difference [95% confidence interval], 0.020 [-0.101 to 0.141]; P = 0.807) and subjective cure rates (83.3% vs 81.3%; risk difference [95% confidence interval], 0.020 [-0.111 to 0.151]; P = 0.821) were similar with the SIS and TOT groups. Both procedures were associated with low complication rates. Repeated surgery rates were 7.6% in the SIS group and 6.3% in the TOT groups. The mesh exposure rate was 1.5% for the SIS group and 3.1% for the TOT group. Incidence of de novo urgency did not vary between TOT and SIS patients. Both groups registered significant life quality improvement. CONCLUSION: After long-term follow-up, anti-incontinence SIS surgery proved noninferior to the inside-out TOT procedure in terms of objective and subjective cure rates.


Subject(s)
Suburethral Slings , Urinary Incontinence, Stress , Urinary Incontinence , Female , Humans , Quality of Life , Suburethral Slings/adverse effects , Treatment Outcome , Urinary Incontinence/surgery , Urinary Incontinence, Stress/surgery
19.
Gynecol Oncol ; 170: 195-202, 2023 03.
Article in English | MEDLINE | ID: mdl-36706646

ABSTRACT

OBJECTIVE: The "intermediate-risk" (IR) group of early-stage cervical cancer patients is characterized by negative pelvic lymph nodes and a combination of tumor-related prognostic risk factors such as tumor size ≥2 cm, lymphovascular space invasion (LVSI), and deep stromal invasion. However, the role of adjuvant treatment in these patients remains controversial. We investigated whether adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with IR cervical cancer. METHODS: We analyzed data from patients with IR cervical cancer (tumor size 2-4 cm plus LVSI OR tumor size >4 cm; N0; no parametrial invasion; clear surgical margins) who underwent primary curative-intent surgery between 2007 and 2016 and were retrospectively registered in the international multicenter Surveillance in Cervical CANcer (SCCAN) study. RESULTS: Of 692 analyzed patients, 274 (39.6%) received no adjuvant treatment (AT-) and 418 (60.4%) received radiotherapy or chemoradiotherapy (AT+). The 5-year disease-free survival (83.2% and 80.3%; PDFS = 0.365) and overall survival (88.7% and 89.0%; POS = 0.281) were not significantly different between the AT- and AT+ groups, respectively. Adjuvant (chemo)radiotherapy was not associated with a survival benefit after adjusting for confounding factors by case-control propensity score matching or in subgroup analyses of patients with tumor size ≥4 cm and <4 cm. In univariable analysis, adjuvant (chemo)radiotherapy was not identified as a prognostic factor in any of the subgroups (full cohort: PDFS = 0.365; POS = 0.282). CONCLUSION: Among patients with IR early-stage cervical cancer, radical surgery alone achieved equal disease-free and overall survival rates to those achieved by combining radical surgery with adjuvant (chemo)radiotherapy.


Subject(s)
Uterine Cervical Neoplasms , Female , Humans , Uterine Cervical Neoplasms/pathology , Neoplasm Staging , Hysterectomy , Combined Modality Therapy , Prognosis , Radiotherapy, Adjuvant , Retrospective Studies
20.
Eur J Neurol ; 30(4): 943-950, 2023 04.
Article in English | MEDLINE | ID: mdl-36511840

ABSTRACT

BACKGROUND AND PURPOSE: During the coronavirus disease 2019 (COVID-19) pandemic many countries reported a decline in stroke volumes. The aim of this study was to analyze if the decline was related to the intensity of the COVID-19 pandemic. METHODS: The first pandemic year (1 March 2020 to 28 February 2021) overall and during the three COVID-19 waves were compared with the preceding year. Volumes of acute ischaemic stroke (AIS), subarachnoid hemorrhage, intracerebral hemorrhage and recanalization treatments (intravenous thrombolysis [IVT] and mechanical thrombectomy [MT]) were obtained from the National Register of Reimbursed Health Services. Door-to-needle time, onset-to-door time and National Institutes of Health Stroke Scale at admission were obtained from the Registry of Stroke Care Quality. RESULTS: During the pandemic year compared to the preceding year there were 26,453 versus 28,771 stroke admissions, representing an 8.8% decline (p < 0.001). The declines (-10%, -11%, -19%) appeared in COVID-19 waves (spring 2020, autumn 2020, winter 2021) except for an increase (2%) during summer 2020. Admissions for AIS declined by 10.2% (p < 0.001), whilst hemorrhagic stroke volumes were minimally decreased. The absolute volumes of IVT and MT decreased by 9.4% (p < 0.001) and 5.7% (p = 0.16), respectively. However, the proportions of ischaemic stroke patients receiving IVT (18% vs. 18%; p = 0.72) and MT (6% vs. 6%; p = 0.28) remained unchanged. CONCLUSIONS: There was a decline in stroke admissions, but such decline was not related to COVID-19 incidence. The frequency of use of recanalization procedures (IVT, MT) and times (onset-to-door time, door-to-needle time) in AIS were preserved in the Czech Republic during the first year of the pandemic.


Subject(s)
Brain Ischemia , COVID-19 , Ischemic Stroke , Stroke , Humans , Stroke/therapy , Brain Ischemia/therapy , Thrombolytic Therapy/methods , Thrombectomy/methods , Pandemics , Treatment Outcome , Hospitalization
SELECTION OF CITATIONS
SEARCH DETAIL
...