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Zusammenfassung Hintergrund Bezogen auf klinische Wirksamkeit und Therapieeffekte von Schaumstoff-Bandagehilfen in der KPE Phase I des Armlymphödems führten die Autoren eine RCT durch, die die Nichtunterlegenheit der Bandagehilfen im Vergleich zu Standarduntermaterial zeigte. Die parallele Erfassung des Polstermaterialverbrauchs und der Applikationsdauer hat die Frage nach ökonomischen und ökologischen Effekten anschließen lassen. Methoden Explorative Analyse des Materialverbrauches und der Applikationszeit von Bandagehilfen im Vergleich mit Standardunterpolsterung in der KPE Phase I bei Patient*innen mit sekundärem Armlymphödem Stadium II bis III. Ergebnisse: 1. Materialverbrauch: Insgesamt wurden im Beobachtungszeitraum in der Kontrollgruppe 50,7 m Schlauchverband und 207 m Polsterwatte bei n=15 Probanden verbraucht. Demgegenüber standen insgesamt 92 m wiederverwendbare Schaumstoffbandagen bei n=15 Proband*innen in der Interventionsgruppe. 2. Applikationszeit: In der Kontrollgruppe belief sich die Applikationszeit im Mittel auf 13,4±3,4 min., in der Inventionsgruppe auf 10,3±2,2 min. Die Analyse zeigt einen signifikanten Gruppenunterschied (p=0.007). Diskussion In der KPE Phase I zeigen sich bei Patient*innen mit Armlymphödem Einsparungen in puncto Materialverbrauch und Applikationsdauer unter Verwendung von Schaumstoffbandagen. Beide Parameter sind für Physiotherapeut*innen und Einrichtungen auch von ökonomischer Relevanz. Die Schaumstoffbandagen haben durch Waschbarkeit und damit Wiederverwendbarkeit überdies ökologische Effekte. Bislang übliche Polstermaterialien werden überwiegend nach der Anwendung verworfen.

Purpose Myopenia and myosteatosis have been proposed to be prognostic factors of surgical outcomes for various diseases, but their exact role in Crohn’s disease (CD) is unknown. The aim of this study is to evaluate their impact on anastomotic leakage, CD recurrence, and postoperative complications after ileocecal resection in patients with CD. Methods A retrospective analysis of CD patients undergoing ileocecal resection at our tertiary referral center was performed. To assess myopenia, skeletal muscle index (skeletal muscle area normalized for body height) was measured using an established image analysis method at third lumbar vertebra level on MRI cross-sectional images. Muscle signal intensity was measured to assess myosteatosis index. Results A total of 347 patients were retrospectively analyzed. An adequate abdominal MRI scan within 12 months prior to surgery was available for 223 patients with median follow-up time of 48.8 months (IQR: 20.0–82.9). Anastomotic leakage rate was not associated with myopenia (SMI: p = 0.363) or myosteatosis index (p = 0.821). Patients with Crohn’s recurrence had a significantly lower SMI (p = 0.047) in univariable analysis, but SMI was not an independent factor for recurrent anastomotic stenosis in multivariable analysis (OR 0.951, 95% CI 0.840–1.078; p = 0.434). Postoperative complications were not associated with myopenia or myosteatosis. Conclusion Based on the largest cohort of its kind with a long follow-up time, we could provide some data that MRI parameters for myopenia and myosteatosis may not be reliable predictors of postoperative outcome or recurrence in patients with Crohn’s disease undergoing ileocecal resection.

Background: Robotic-assisted colorectal surgery is gaining popularity, but limited data are available on the safety, efficacy, and cost of robotic-assisted restorative proctectomy with the construction of an ileal pouch and ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC). Methods: A retrospective study was conducted comparing consecutively performed robotic-assisted and laparoscopic proctectomy with IPAA between 1 January 2016 and 31 September 2021. In total, 67 adult patients with medically refractory UC without proven dysplasia or carcinoma underwent surgery: 29 operated robotically and 38 laparoscopically. Results: There were no differences between both groups regarding postoperative complications within 30 days according to Clavien-Dindo classification’ grades 1–5 (51.7% vs. 42.1%, p = 0.468) and severe grades 3b–5 (17.2% vs. 10.5%, p = 0.485). Robotic-assisted surgery was associated with an increased urinary tract infection rate (n = 7, 24.1% vs. n = 1, 2.6%; p = 0.010) and longer operative time (346 ± 65 min vs. 281 ± 66 min; p < 0.0001). Surgery costs were higher when operated robotically (median EUR 10.377 [IQR EUR 4.727] vs. median EUR 6.689 [IQR EUR 3.170]; p < 0.0001), resulting in reduced total inpatient profits (median EUR 110 [IQR EUR 4.971] vs. median EUR 2.853 [IQR EUR 5.386]; p = 0.001). Conclusion: Robotic-assisted proctectomy with IPAA can be performed with comparable short-term clinical outcomes to laparoscopy but is associated with a longer duration of surgery and higher surgery costs. As experience increases, some advantages may become evident regarding operative time, postoperative recovery, and length of stay. The robotic procedure might then become cost-efficient.

Hintergrund In der Entstauungsphase der Komplexen Physikalischen Entstauungstherapie des Lymphodems (KPE Phase I) werden verschiedene Untermaterialien eingesetzt, um die Anlage der Kurzzugbinden zu stabilisieren und die Haut zu schutzen. Eine neuartige Form der Unterpolsterung bieten mit Baumwolle umnahte Schaumstoffbandagen. Deren Therapieeffekte sind jedoch bislang nicht untersucht. Material und Methoden Prospektive, randomisierte Nichtunterlegenheitsstudie an Proband/innen mit sekundarem Armlymphodem. Die Kontrollgruppe erhielt eine KPE Phase I mit Standardtherapie (Unterpolsterung aus Schlauchverband und Wattebinde), die Interventionsgruppe erhielt die KPE Phase I mit Schaumstoffbandagen (SC). Primarer Endpunkt war das optoelektronisch gemessene Volumen. Zudem wurde die Umfangsreduktion ermittelt und die Patientenperspektive erfragt. Ergebnisse n=30 Proband/innen konnten analysiert werden. SC zeigten einen signifikant groseren Effekt in der Volumenreduktion (p=0,026; 95% Kl [−207,9;+7,4]). Bei apriori definiertem Aquivalenzbereich von±50 ml sind SC der Referenztherapie nicht unterlegen. Die Patienten bewerteten die Abnahme des Spannungsgefuhls sowie den Tragekomfort bei SC signifikant besser (p=0,026 sowie p=0,003). Schlussfolgerung Schaumstoffbandagen sind Standardpolstermaterial nicht unterlegen. Sie konnen in der Entstauungsphase von Lymphodemen als alternatives Unterpolsterungsmaterial eingesetzt werden. Die Daten liefern Hinweise darauf, dass sie die Reduktion des Odemvolumens im Vergleich mit bislang verwendeten Untermaterialien verbessern konnen und das Spannungsgefuhl durch sie deutlicher reduziert werden kann. Background In the intensive phase of complex decongestive therapy for lymphedema (CDT Phase I), different padding materials are used underneath short-stretch bandages to avoid skin lesions and slipping. Foam bandages with vertical foam channels offer a novel form of sub-compression under-padding. Their therapeutic effects have not yet been investigated. Material and methods Prospective, randomized non-inferiority trial in subjects with CDT phase I for treatment of secondary arm lymphedema. The control group received usual care consisting of sub-compression application of stockinettes and cotton-wool bandages, while the intervention group received sub-compression foam bandages (SC). Volume effects were compared between the groups. Circumference reduction effects and the patient's perspective were surveyed as secondary outcomes. Results n=30 subjects could be analyzed. SC showed a significantly greater effect in volume reduction (p=0.026; 95% cl [−207.9;+7.4]). According to the apriori defined equivalence interval of±50 ml SC are non-inferior to reference therapy. Patients using SC reported a significantly greater decrease in their feeling of tension as well as significantly greater wearing comfort (p=0.026 and p=0.003). Conclusions SC are non-inferior to standard padding material. They can be used as an alternative underpadding material in the intensive phase of complex decongestive therapy of lymphedema. The data suggest that they could improve the reduction of volume compared to conventional padding materials and further reduce a patients’ feeling of tension.

Purpose Prolonged postoperative ileus (PPOI) is common after bowel resections, especially in Crohn’s disease (CD). The pathophysiology of PPOI is not fully understood. PPOI could affect only the upper or lower gastrointestinal (GI) tract. The aim of this study was to assess risk factors for diverse types of PPOI, particularly to differentiate PPOI of upper and lower GI tract. Methods A retrospective analysis of 163 patients with CD undergoing ileocecal resection from 2015 to 2020 in a single center was performed. PPOI of the upper GI tract was predefined as the presence of vomiting or use of nasogastric tube longer than the third postoperative day. Lower PPOI was predefined as the absence of defecation for more than three days. Independent risk factors were identified by multivariable logistic regression analysis. Results Overall incidence of PPOI was 42.7%. PPOI of the upper GI tract was observed in 30.7% and lower PPOI in 20.9% of patients. Independent risk factors for upper PPOI included older age, surgery by a resident surgeon, hand-sewn anastomosis, prolonged opioid analgesia, and reoperation, while for lower PPOI included BMI ≤ 25 kg/m2, preoperative anemia, and absence of ileostomy. Conclusion This study identified different risk factors for upper and lower PPOI after ileocecal resection in patients with CD. A differentiated upper/lower type approach should be considered in future research and clinical practice. High-risk patients for each type of PPOI should be closely monitored, and modifiable risk factors, such as preoperative anemia and opioids, should be avoided if possible.

Zusammenfassung Hintergrund Gonarthrose ist die am weitesten verbreitete Gelenkerkrankung der Welt und hat in Deutschland eine Prävalenz von 10,6 %. Wassergefilterte Infrarot-A Strahlung (wIRA) wird unter anderem zur physikalischen Therapie von Morbus Bechterew und Arthritis psoriatica erfolgreich angewendet. Die wIRA-Behandlung für Gonarthrose zeigte schon in einer Patientenbeobachtung 1995 (n=20) positive Effekte. Diese Ergebnisse sollen nun mittels RCT verifiziert werden. Material und Methoden In einer randomisiert-kontrollierten Studie wurden n=108 Probanden mit Gonarthrose eingeschlossen. Die Probanden der Interventionsgruppe bestrahlten ihr beschwerdedominantes Knie im häuslichen Umfeld über den Zeitraum von 30 Tagen jeweils mindestens eine Stunde pro Tag. Die Kontrollgruppe erhielt keine, über die zuvor bereits durchgeführten Therapiemaßnahmen hinausgehende, Intervention (Standardtherapie). Zu Beginn und Ende der Studie wurden alle Teilnehmer klinisch evaluiert (Bewegungsumfang, Einbeinstand, KOOS, Schmerzen, Lebensqualität), zusätzlich wurden wöchentliche Befragungen durchgeführt. Ergebnisse Die belastungsabhängigen Knieschmerzen zeigten sich bereits nach 2 Wochen statistisch signifikant reduziert (VAS−12 vs. − 2 mm; p Schlussfolgerung Der Einsatz von wIRA bei Gonarthrose zeigt sich als Therapieoption, die Schmerzen unter Belastung signifikant reduzieren und die Lebensqualität der Patienten signifikant steigern kann.

Based on centroblast frequency, follicular lymphoma (FL) is subdivided into grades 1-2, 3A, and 3B. Grade FL3A frequently coexists with FL1-2 (FL1-2-3A). Based on clinical trials, FL1-2 is treated with rituximab (R) or obinutuzumab plus bendamustine (B) or CHOP, while FL3B is treated with R-CHOP. In contrast, there are little data guiding therapy in FL3A. We present a retrospective, multicenter analysis of 95 FL3A or FL1-2-3A and 203 FL1-2 patients treated with R-CHOP or R-B first-line. R-CHOP facilitated a higher response rate (95% versus 76%) and longer overall survival (OS) (3-year OS 89% versus 73%, P = 0.008) in FL3A or FL1-2-3A, whereas the difference in progression-free survival (PFS) did not reach statistical significance. While transformation rates into aggressive lymphoma were similar between both groups, there were more additional malignancies after R-B compared with R-CHOP (6 versus 2 cases). In FL1-2, R-B achieved a higher 3-year PFS (79% versus 47%, P

Zusammenfassung Hintergrund Die in der Erhaltungsphase der komplexen physikalischen Entstauungstherapie notwendige Kompressionstherapie kann anstelle von Flachstrick-Kompressionsstrümpfen (FS) auch mit vom Patienten selbst anzulegenden Bandagen erfolgen, den sogenannten medizinischen adaptiven Kompressionssystemen (MAK). Methoden MAK und FS wurden mittels In-vivo-Druckmessungen unter der von Probanden selbst angelegten Kompression direkt verglichen. Dazu wurden Drücke über Picopress-Messgeräte und Sensoren (Microlab Elettronica, Italien) an n = 30 Patienten mit beidseitigen, symmetrischen, lymphostatischen Ödemen der Unterschenkel erfasst. FS und MAK wurden seitenrandomisiert zugewiesen. Nach Standardeinweisung und initialen Druckmessungen beider Systeme wurden MAK im Zeitverlauf von 2 und 4 h Tragedauer erneut gemessen. Static-Stiffness-Index (SSI) sowie Druckgradienten der Messhöhen B1-C wurden berechnet. Ergebnisse MAK zeigen Ruhedruckwerte und SSI im therapeutischen Bereich, die signifikant höher ausfallen als bei FS (p Diskussion Die mit MAK erreichten Druckparameter untermauern deren therapeutische Effektivität. Die Anwendung von MAK ist auch ohne Nachjustieren druckstabil. Die Anwendung (Selbstanlage) kann als therapeutisch wirksam eingestuft werden. Eine gute Einweisung der Patienten ist jedoch bedeutsam.

To analyze the impact of the dose to the optic disc and the irradiated length of the optic nerve on radiation-induced optic neuropathy, radiation-induced retinopathy, iris neovascularization, secondary glaucoma, enucleation, and local tumor control after proton beam therapy (PBT) of choroidal melanoma. Retrospective analysis of 1129 patients, who received primary PBT for the treatment of choroidal melanoma with a dose of 60 cobalt gray equivalents (CGE) between 1998 and 2013 at the Helmholtz-Zentrum Berlin, Germany. Kaplan-Meier curves and logrank test have been used for time-to-event analyses. Adjustment for potential confounders was done using multiple Cox regression models with forward and backward selection. We found a significant correlation between the irradiated length of the optic nerve and the dose to the optic disc (correlation coefficient, 0.93). Multivariate Cox regression revealed the dose to the optic disc as an independent predictive risk factor for the development of radiation-induced optic neuropathy (p < 0.001, HR 1.023, 95 CI 1.016–1.029), iris neovascularization (p < 0.001, HR 1.013, 95% CI 1.008–1.019), secondary glaucoma (p < 0.001, HR 1.017, 95% CI: 1.011-1.023) and enucleation (p < 0.001, HR 1.037, 95% CI 1.020-1.053). The irradiated length of the optic nerve was not a statistically independent predictive risk factor in multivariate analysis. Our data implicate the predominance of the dose to the optic disc over the irradiated length of the optic nerve regarding radiation-induced optic neuropathy, iris neovascularization, secondary glaucoma, and enucleation.

Zusammenfassung Hintergrund Medizinische Adaptive Kompressionssysteme (MAK) sind mit Klettverschlüssen adjustierbare Kompressionsbandagen. Diese erweitern das Spektrum der therapeutischen Optionen in der komplexen physikalischen Entstauungstherapie (KPE). Die Studienlage zu MAK ist spärlich, es werden Vorteile in der der KPE Phase I beschrieben. Über die Durchführbarkeit und Sicherheit der Anwendung von MAK in der KPE Phase II existiert keine belastbare Evidenz. Methoden Prospektive, randomisierte Nichtunterlegenheitsstudie. Probanden mit symmetrischen lymphostatischen Ödemen der Unterschenkel (n=30) wurden parallel mit neu angepasster Flachstrick-Kompression (FS) und MAK 3 Tage lang behandelt. Primäres Outcome waren die perometrisch gemessenen Volumeneffekte der MAK im Vergleich mit der Referenztherapie (FS). Zudem wurden die Anwendungssicherheit und die Handhabung (Patientenperspektive) überprüft. Ergebnisse MAK sind, auch ohne regelmäßiges Nachjustieren, der Referenztherapie mit FS in der KPE Phase II nicht unterlegen (Vergleich der Differenzen der Volumeneffekte; p=0,163; 95%-KI [−38,2;+6,8] bei einem apriori definierten Äquivalenzbereich von±50 ml). MAK zeigten keine Nebenwirkungen. Patienten berichten im Vergleich mit FS ein signifikant leichteres An- und Ablegen der MAK bei vergleichbarem Tragekomfort. Schlussfolgerung Die Daten belegen die Nichtunterlegenheit von MAK gegen die Referenztherapie mit FS. MAK können in der Erhaltungstherapie von lymphostatischen Erkrankungen als alternative Kompressionstherapie eingesetzt werden. Die Anwendung (Selbstanlage) kann als sicher eingestuft werden. Eine gute Einweisung von Patienten ist bedeutsam. Patienten mit Schwierigkeiten in der Handhabung von Kompressionsstrümpfen beim An- und Ausziehen können von MAK profitieren. Patienten mit sehr ausgeprägten Ödemen müssen während der MAK-Nutzung gegebenenfalls größere Schuhe tragen. Studien mit längeren Beobachtungsdauern sollten folgen.

Background There is a high incidence of pressure ulcers in high-risk settings such as intensive care. There is emerging evidence that the application of dressings to pressure ulcer predilection areas (sacrum and heels) improves prevention strategies. Objectives To determine whether preventive dressings, applied to the sacrum and heels of high-risk patients in intensive care units, in addition to standard prevention, reduces the incidence of pressure ulcers. Methods Between June 2015 and July 2018, a randomized, controlled, two-arm, superiority pragmatic study was performed with a concealed 1 : 1 allocation to the intervention and control group. Patients assigned to the intervention group had dressings applied to the sacrum and heels. Results In total, 7575 patients were screened for eligibility and 475 patients were included and allocated to both groups. Finally, 212 patients in the intervention group and 210 in the control group were analysed. The mean age was 63 center dot 5 years and the majority of patients were male (65 center dot 4%). The cumulative pressure ulcer incidence category II and above was 2 center dot 8% in the intervention, and 10 center dot 5% in the control group (P = 0 center dot 001). Compared with the control group, the relative risk in the intervention group was 0 center dot 26 [95% confidence interval (CI) 0 center dot 11-0 center dot 62] and the absolute risk reduction was 0 center dot 08 (95% CI 0 center dot 03-0 center dot 13). Conclusions The results indicate that the application of dressings, in addition to standard prevention, in high-risk intensive care unit patients is effective in preventing pressure ulcers at the heels and sacrum. What's already known about this topic? Pressure ulcers are severe soft tissue injuries and wounds, which occur worldwide in all healthcare settings. Despite preventive interventions, pressure ulcers still develop. There is emerging evidence that dressings help to prevent pressure ulcers. What does this study add? The incidence of pressure ulcers in intensive care units among high-risk patients remains high. The application of dressings to the sacrum and heels, in addition to standard preventive measures, reduces the relative and absolute risks for the development of pressure ulcers. The application of preventive dressings at the heels and sacrum seems to be feasible in intensive care settings.

Aim: Heart failure negatively impacts quality of life (QoL), which in turn contributes to an adverse long-term prognosis. We aimed at identifying biomarker trajectories after an episode of acutely decompensated heart failure (ADHF) that differ between patients showing average versus impaired QoL 1 year later, thus allowing to predict impaired QoL. Methods: Biomarkers were repeatedly measured throughout the year in 104 ADHF patients. QoL was assessed at discharge and 1 year after ADHF. Logistic regression and receiver operating characteristic analyses were used to identify predictors of impaired QoL while controlling psychosocial confounders. Results: MR-proANP predicted impaired physical and mental QoL. NT-proBNP measurements were important predictors for poor physical QoL. Conclusion: MR-proANP and NT-proBNP predict poor QoL after an epidode of ADHF. The trial is registered at http://clinicaltrials.gov as MOLITOR (IMpact of therapy optimisation On the Level of biomarkers in paTients with Acute and Decompensated ChrOnic HeaRt Failure) with unique identifier: NCT01501981.

Background During the current severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic, computed tomography (CT) has become widely used in patients with suspected or known coronavirus disease 2019 (COVID-19). This prospective observational study in 28 invasively ventilated and 18 non-invasively ventilated patients with confirmed SARS-CoV-2 contamination aims at investigating SARS-CoV-2 contamination of CT scanner surfaces and its infectiousness. Methods Swab sampling of the CT table and gantry before and after CT examinations was performed. Additionally, the CT ventilation system air grid was wiped off after each examination. Real-time reverse-transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 RNA (ribonucleic acid) and viral cell culture were performed in the virology core lab. Results After examination of non-invasively ventilated or non-ventilated patients, SARS-CoV-2 RNA was found in 11.1% (4/36) on patient near surfaces (CT table and gantry) and in 16.7% (3/18) on the CT air grid respectively after examination of invasively ventilated patients in 5.4% (3/56) on CT table and gantry and 7.1% (2/28) on the CT air grid. Surface contamination was more common in non-invasively ventilated or non-ventilated patients with a high viral load who were actively coughing. RT-PCR cycle threshold (Ct) was high (35.96–39.31) in all positive samples and no positive viral cell culture was found. Conclusion Our study suggests that CT scanner surface contamination with SARS-CoV-2 is considerable and more common after examination of non-invasively ventilated or non-ventilated patients compared to invasively ventilated patients. However, no viral cell culture positivity was found, hence the infectious potential seems low.

Any experiment involving living organisms requires justification of the need and moral defensibleness of the study. Statistical planning, design, and sample size calculation of the experiment are no less important review criteria than general medical and ethical points to consider. Errors made in the statistical planning and data evaluation phase can have severe consequences on both results and conclusions. They might proliferate and thus impact future trials-an unintended outcome of fundamental research with profound ethical consequences. Unified statistical standards are currently missing for animal review boards in Germany. In order to accompany, we developed a biometric form to be filled and handed in with the proposal at the concerned local authority on animal welfare. It addresses relevant points to consider for biostatistical planning of animal experiments and can help both the applicants and the reviewers in overseeing the entire experiment(s) planned. Furthermore, the form might also aid in meeting the current standards set by the 3+3R's principle of animal experimentation: Replacement, Reduction, Refinement as well as Robustness, Registration, and Reporting. The form has already been in use by the concerned local authority of animal welfare in Berlin, Germany. In addition, we provide reference to our user guide giving more detailed explanation and examples for each section of the biometric form. Unifying the set of biostatistical aspects will help both the applicants and the reviewers to equal standards and increase quality of preclinical research projects, also for translational, multicenter, or international studies.

AimsInflammation is a key driver of atherosclerosis and myocardial infarction (MI), and beyond proteins and microRNAs (miRs), long noncoding RNAs (lncRNAs) have been implicated in inflammation control. To obtain further information on the possible role of lncRNAs in the context of atherosclerosis, we obtained comprehensive transcriptome maps of circulating immune cells (peripheral blood mononuclear cells, PBMCs) of early onset MI patients. One lncRNA significantly suppressed in post-MI patients was further investigated in a murine knockout model.Methods and resultsIndividual RNA-sequencing (RNA-seq) was conducted on PBMCs from 28 post-MI patients with a history of MI at age ≤50 years and stable disease ≥3 months before study participation, and from 31 healthy individuals without manifest cardiovascular disease or family history of MI as controls. RNA-seq revealed deregulated protein-coding transcripts and lncRNAs in post-MI PBMCs, among which nuclear enriched abundant transcript (NEAT1) was the most highly expressed lncRNA, and the only one significantly suppressed in patients. Multivariate statistical analysis of validation cohorts of 106 post-MI patients and 85 controls indicated that the PBMC NEAT1 levels were influenced (P = 0.001) by post-MI status independent of statin intake, left ventricular ejection fraction, low-density lipoprotein or high-density lipoprotein cholesterol, or age. We investigated NEAT1−/− mice as a model of NEAT1 deficiency to evaluate if NEAT1 depletion may directly and causally alter immune regulation. RNA-seq of NEAT1−/− splenocytes identified disturbed expression and regulation of chemokines/receptors, innate immunity genes, tumour necrosis factor (TNF) and caspases, and increased production of reactive oxygen species (ROS) under baseline conditions. NEAT1−/− spleen displayed anomalous Treg and TH cell differentiation. NEAT1−/− bone marrow-derived macrophages (BMDMs) displayed altered transcriptomes with disturbed chemokine/chemokine receptor expression, increased baseline phagocytosis (P ConclusionThe study indicates distinctive alterations of lncRNA expression in post-MI patient PBMCs. Regarding the monocyte-enriched NEAT1 suppressed in post-MI patients, the data from NEAT1−/− mice identify NEAT1 as a novel lncRNA-type immunoregulator affecting monocyte-macrophage functions and T cell differentiation. NEAT1 is part of a molecular circuit also involving several chemokines and interleukins persistently deregulated post-MI. Individual profiling of this circuit may contribute to identify high-risk patients likely to benefit from immunomodulatory therapies. It also appears reasonable to look for new therapeutic targets within this circuit.

Newer capsule with a panoramic viewing mode is available and might increase the detection rate of bleeding lesions in patients with obscure gastrointestinal bleeding (OGIB). Furthermore, an improved patient acceptance rate is expected.In a randomized prospective comparative multicenter study, patients with OGIB were included and examined either with CapsoCam SV-1 or with PillCam SB 3. Detection of bleeding lesions, transit, and evaluation time and adverse events were evaluated. Physicians were interviewed about their experience with both capsules and the evaluation software. A detailed subject questionnaire analyzed acceptance of each capsule. Follow-up was 3 months.In total, 181 patients with OGIB were recruited into the study. After exclusion of 28 patients 153 patients were randomized and CapsoCam SV-1 (n=78) or PillCam SB 3 (n=75) was administered. CapsoCam SV-1 detected more cases of bleeding (31/79, diagnostic yield 39.7%) compared with PillCam SB 3 (26/75, diagnostic yield 34.6%, NS). Transit time of both capsules was not different. Evaluation time with PillCam SB 3 was superior to CapsoCam SV-1 (27 vs. 40 min, P=0.01). In total, 95% of the physicians were satisfied with each capsule system and evaluation software. The acceptance rate of the patients to retrieve the CapsoCam SV-1 was high. Adverse events/serious adverse events were 17.9%/1.3% with CapsoCam SV-1 and 16%/0% with PillCam SB 3. Rebleeding rate was 28.75% within 3 months.CapsoCam SV-1 detected more lesions; however, relevant bleeding sources were visualized by both capsules. Physician's satisfaction was high with both capsule systems and evaluation software. Patient's acceptance with CapsoCam SV-1 was unexpectedly high. Serious adverse events were 0% with PillCam SB 3 and 1.3% with CapsoCam SV-1.

Introduction: Proton beam therapy is an established primary treatment for patients with nonmetastasized uveal melanoma. Adjuvant local interventions, like intravitreal injections or surgery, were shown to improve long-term eye preservation; however, their impact on the patient’s quality of life (QOL) remains unknown. Methods: In a post-radiotherapeutic follow-up, we prospectively collected data on QOL, visual acuity, and interventional adjuvant procedures. QOL was measured with QOL-C30 questionnaire and quality of life questionnaire OPT30 at baseline, and at 3 and 12 months after proton therapy. Patients were grouped by the type of adjuvant treatment. The impact on QOL was analyzed by comparing changes in the mean score values and visual acuity for different interventional subgroups, with generalized linear mixed models and Wilcoxon signed-rank tests. Results: We received 108 (100%) and 95 (88.0%) questionnaires at 3 and 12 months post-therapy, respectively. Adjuvant interventions included observation (n = 61, 56.5%), intravitreal injections (n = 17, 15.7%), and an intraocular surgical procedure (n = 30, 27.8%). In the latter group, several QOL items significantly declined after the 3-month adjuvant interval, but they partially recovered at the 12-month follow-up. In all adjuvant-intervention groups, global QOL scores returned to baseline levels at 12 months. Conclusion: Posttreatment adjuvant interventions had no long-lasting effects on QOL in patients with uveal melanoma.

Background A recently developed haemostatic peptide gel for endoscopic application has been introduced to improve the management of gastrointestinal bleeding. The aim of this pilot study was to evaluate the feasibility, safety, efficacy and indication profiles of PuraStat in a clinical setting. Methods In this prospective observational multicentre pilot study, patients with acute non-variceal gastrointestinal bleeding (upper and lower) were included. Primary and secondary application of PuraStat was evaluated. Haemoglobin, prothrombin time, platelets and transfusion behaviour were documented before and after haemostasis. The efficacy of PuraStat was assessed during the procedure, at 3 days and 1 week after application. Results 111 patients with acute gastrointestinal bleeding were recruited into the study. 70 percent (78/111) of the patients had upper gastrointestinal bleeding and 30% (33/111) had lower gastrointestinal bleeding. After primary application of PuraStat, initial haemostatic success was achieved in 94% of patients (74/79, 95% CI 88–99%), and in 75% of the patients when used as a secondary haemostatic product, following failure of established techniques (24/32, 95% CI 59–91%). The therapeutic success rates (absence of rebleeding) after 3 and 7 days were 91% and 87% after primary use, and 87% and 81% in all study patients. Overall rebleeding rate at 30 day follow-up was 16% (18/111). In the 5 patients who finally required surgery (4.5%), PuraStat allowed temporary haemostasis and stabilisation. Conclusions PuraStat expanded the therapeutic toolbox available for an effective treatment of gastrointestinal bleeding sources. It could be safely applied and administered without complications as a primary or secondary therapy. PuraStat may additionally serve as a bridge to surgery in order to achieve temporary haemostasis in case of refractory severe bleeding, possibly playing a role in preventing immediate emergency surgery.

Background: Ileostomy is often required in patients undergoing bowel resections for inflammatory bowel diseases (IBD), colorectal cancer, and emergencies. Unfortunately, some patients develop a high-output stoma (HOS). This condition affects homeostasis and may be life threatening. We aimed to identify possible risk factors for the development of HOS. Patients and methods: From 2012 to 2018, 296 patients who underwent ileostomy at Charite - Universitatsmedizin Berlin, Campus Benjamin Franklin were retrospectively analyzed. Emergency operations were included. Diverting ileostomy, end ileostomies and anastomotic stomata with at least part ileum, were examined. HOS was defined as stoma output of more than 1,000 mL per day for more than 3 days. Univariate and multivariable analyses were used to detect potential risk factors for the development of HOS. Results: 41 of 296 patients developed HOS (13.9%). Mortality was 0.3%. In the univariate analysis, age (p < 0.002), diagnosis (Crohn's disease, p = 0.005), arterial hypertension (p = 0.023), surgical procedure (right-sided colectomy, small bowel resection, p < 0.001), open technique (p < 0.002), emergencies (p = 0.014), and anastomotic ileostomy (p < 0.001) were identified as risk factors. In the multivariable logistic regression, older age, diagnosis (Crohn's disease) and surgical procedure (right-sided colectomy, separate ileostomy, small bowel resection) remained significant risk factors. Conclusion: The occurrence of HOS is a relevant problem after ileostomy. The identification of risk factors for a high-output may be helpful for monitoring, early diagnosis and initiation of therapy as well as in the planning of close follow-up care.

Purpose The German Classification of Diverticular Disease was introduced a few years ago. The aim of this study was to determine whether Classification of Diverticular Disease enables an exact stratification of different types of diverticular disease in terms of course and treatment. Methods This was a prospective, bicentric observational trial. Patients aged ≥ 18 years with diverticular disease were prospectively included. The primary endpoint was the rate of recurrence within 2 year follow-up. Secondary outcome measures were Gastrointestinal Quality of Life Index, Quality of life measured by SF-36, frequency of gastrointestinal complaints, and postoperative complications. Results A total of 172 patients were included. After conservative management, 40% of patients required surgery for recurrence in type 1b vs. 80% in type 2a/b (p = 0.04). Sixty percent of patients with type 2a (micro-abscess) were in need of surgery for recurrence vs. 100% of patients with type 2b (macro-abscess) (p = 0.11). Patients with type 2a reached 123 ± 15 points in the Gastrointestinal Quality of Life Index compared with 111 ± 14 in type 2b (p = 0.05) and higher scores in the “Mental Component Summary” scale of SF-36 (52 ± 10 vs. 43 ± 13; p = 0.04). Patients with recurrent diverticulitis without complications (type 3b) had less often painful constipation (30% vs. 73%; p = 0.006) when they were operated compared with conservative treatment. Conclusion Differentiation into type 2a and 2b based on abscess size seems reasonable as patients with type 2b required surgery while patients with type 2a may be treated conservatively. Sigmoid colectomy in patients with type 3b seems to have gastrointestinal complaints during long-term follow-up. Trial registration https://www.drks.de ID: DRKS00005576

Proinflammatory cytokines play an important role in abdominal surgery and are often associated with the development of postoperative ileus, especially in Crohn's disease. The aim of this study was to investigate proinflammatory cytokine levels in mesenteric fat in Crohn's disease and patients without Crohn's disease.Human mesenteric tissue specimen were divided into 3 patient groups (n = 10 each): minor surgery (laparoscopic cholecystectomy), major surgery (colectomy) in patients without Crohn's disease, and major surgery (colectomy) in patients with Crohn's disease. Levels of interleukin 6, interleukin 1-β, and tumor necrosis factor α were determined by cytometric bead array, enzyme-linked immunosorbent assay and reverse transcription polymerase chain reaction. The Kruskal-Wallis and the Mann-Whitney U test were used to compare continuous variables. For categorical variables, the χIn minor surgery, cytokines levels of interleukin 6, interleukin 1-β and Tumor necrosis factor α were low (ie, interleukin 6: 1 pg/mL [0-36], interleukin 1-β: 0 fg/mL [0-18], tumor necrosis factor α: 157 fg/mL [91-237]) compared with major surgery in patients with and without Crohn's disease. Cytokines were significantly higher in major surgery (ie, interleukin 6: 147 pg/mL [29-347], interleukin 1-β: 660 fg/mL [0-2580], tumor necrosis factor α: 532 fg/mL [289-1647]; P = .02 and major surgery with CD (cytometric bead array: interleukin 6: 94 pg/mL [24-627], interleukin 1-β: 708 fg/mL [0-1664], tumor necrosis factor α: 733 fg/mL [209-1,354]; P.05). Cytokine levels in major surgery with Crohn's disease showed a further increase of interleukin 6 in polymerase chain reaction in comparison to major surgery in patients without Crohn's disease (1.2 vs 4, P = .04).Proinflammatory cytokines are increased in the mesenteric fat in major operations compared to minor operations, which indicates local mesenteric inflammation. In Crohn's disease, levels of proinflammatory cytokines are even higher, which may put the patients at risk for postoperative ileus.

Purpose Creation of an optimal bowel anastomosis with low postoperative leakage rate is an immanent part of colorectal surgery contributing to recovery, length of hospital stay and overall hospital costs. We aimed to investigate costs of small and large bowel resection, length of hospital stay, anastomotic leakage rate and its risk factors depending on the anastomotic technique. Methods Retrospective analysis of 198 patients (67 stapled and 131 hand-sewn anastomoses) undergoing elective bowel resection with a single anastomosis without protective ileostomy either stapled or in double-rowed running suture technique between 1st October 2012 and 30th September 2018 at Charite University Hospital Berlin, Campus Benjamin Franklin. We analyzed costs of treatment, total length of hospital stay, rate of anastomotic leakage and possible risk factors for anastomotic leak. Results No significant difference between both anastomotic techniques could be detected for hospital stay (p = 0.754), 30-day-readmission rate (p = 0.827), or anastomotic leakage (p = 606). Neither comorbidities (p = 0.449), underlying disease (p = 0.132), experience of the surgical team (p = 0.828) nor scheduling of the operation (p = 0.531) were associated with anastomotic leakage. Stapled anastomoses took 22 min less operation time than sutured anastomoses (130 vs. 152 min. Median) (p = 0.001). Operations with stapled anastomoses saved 183 € in operation costs and 496 € in overall hospital costs. Conclusion Stapled and hand-sewn bowel anastomoses can be performed equally safe without differences in postoperative outcome. No patient, procedure or surgeon related risk factors for anastomotic leakage could be detected. Bowel resections with stapled anastomoses take less time and save operation and overall hospital costs.

Background The safety of synthetic mesh in elective hernia repair in the setting of immunosuppression lacks national and international consensus. The aim of our analysis was to explore the effects of immunosuppression on the rates of wound complications. Methods Comparative analysis of immunocompetent and immunocompromised patients with elective mesh repair of inguinal, femoral, primary ventral, incisional or parastomal hernia between January 2001 and December 2013. Immunosuppression included glucocorticoids, biologicals, chemotherapy and chemoradiotherapy. Primary outcome parameter was mesh infection rate. Follow-up questionnaires were completed in written form or by telephone interview. Results Questionnaire response rate was 59.5% (n = 194) with a median follow-up of 33 (interquartile range: 28-41) months. There were no differences between immunocompromised (n = 40, 20.6%) and immunocompetent patients (n = 154, 79.4%) based on hernia and patient characteristics. Immunosuppression was not associated with the rates of mesh infection (P = 1.000), surgical site infection (SSI, P = 0.330) or re-operation for SSI (P = 0.365), but with higher rates (P = 0.007) and larger odds for hernia recurrence (odds ratio 3.264, 95% confidence interval 1.304-8.172; P = 0.012). Mesh infection also increased the odds for hernia recurrence (odds ratio 11.625; 95% confidence interval 1.754-77.057; P = 0.011). Only in the subset of ventral/incisional hernias, immunocompromised (n = 8, 40%) patients had higher recurrence rates than immunocompetent patients (n = 5, 11.6%; P = 0.017). Patients with SSI reported more frequently moderate to severe dysesthesia at the surgical site (P = 0.013) and would less frequently re-consent to surgery (P = 0.006). Conclusion Immunosuppression does not increase the rate of wound infections after elective hernia repair with synthetic mesh. However, immunosuppression and mesh infection are risk factors for hernia recurrence.

Background Dry skin and the associated impaired epidermal barrier function are postulated to constitute a major element in the development of atopic dermatitis. Objective The aim of this study was to evaluate the effect of two plant-based formulations on the epidermal barrier function in a defined cohort of infants with a predisposition for atopic dermatitis. Methods Over a period of 16 weeks, 25 infants who were ages 3 to 12 months and had an atopic predisposition and dry skin received two emollients that contained pressed juice of the ice plant. The infants received both cream and lotion on the forearm, only cream on the face, and only lotion on the leg. Stratum corneum hydration (SCH), transepidermal water loss (TEWL), skin surface pH, and sebum were assessed on the infants' forehead, leg, and forearm. The Scoring Atopic Dermatitis (SCORAD) index was used for the clinical assessment. Results SCH significantly increased in all body regions that were assessed. The forearm and leg revealed stable levels of pH and TEWL, but a decline in pH (week 16) and TEWL (week 4) was noted on the forehead. At week 16, sebum levels were lower on the forehead compared with those at baseline. SCORAD scores improved significantly during the study. Conclusion A daily application of both emollients was associated with increased SCH levels and a stable course of TEWL, pH, and sebum on the forehead except for the forehead when compared with the forearm and leg. Clinically, improved SCORAD scores were noted.

In patients on oral antiplatelet therapy secondary to critical vascular diseases, the risk of interrupting antiplatelet therapy has to be weighed against the risk of postoperative hematoma or bleeding when surgery is planned. The goal of this study was to determine the risk of postoperative hematoma and postoperative bleeding in elective inguinal hernia surgery during continuous platelet inhibition. Patients receiving either elective total extraperitoneal hernioplasty or Lichtenstein repair for inguinal hernia were included. Patients with mere suture repair, emergency hernia repair, combination of different simultaneous operations, and patients under therapeutic anticoagulation with heparin were excluded. Postoperative bleeding/hematoma was determined by physical examination and graded according to the Clavien-Dindo classification. Between January 2006 and December 2013, 561 patients with elective surgical repair of an inguinal hernia were included. A total of 29 patients were under continuous perioperative platelet inhibition (PI) with either aspirin or clopidogrel in addition to perioperative antithrombotic prophylaxis with subcutaneous dalteparin injections (PI group). A total of 532 patients received perioperative antithrombotic prophylaxis only (control group). The number of patients under antiplatelet therapy increased from 1.3% (Jan. 2006–Dec. 2009) to 10.0% (Jan. 2010–Dec. 2013; P < 0.0001). Postoperative hematoma/bleeding occurred in 5 PI patients (17.2%) versus 38 control patients (7.1%, P = 0.062). Rate of postoperative bleeding or hematoma is not higher under mono antiplatelet therapy for elective inguinal hernia repair. Since the majority of hematomas can be treated conservatively, it seems unnecessary to stop mono platelet inhibition perioperatively.

Background Aged residents of institutional long-term care facilities are at high risk for developing skin and tissue diseases. Besides various common skin problems, dry skin (xerosis cutis) is one of the most frequent skin conditions in this setting. Objectives To investigate the effectiveness of two structured skin care regimens in comparison to routine skin care on xerosis cutis in nursing home residents. Design A multi-center, pragmatic, randomized, controlled, investigator blinded study with three parallel groups. Settings The study was conducted in a random sample of ten out of 291 institutional long-term care facilities of the federal state of Berlin, Germany. Participants Long-term care residents being 65+ years affected by dry skin were included. Methods The residents were allocated into one of three study groups. Two interventional groups used standardized skin care regimens, consisting of a body wash and twice daily applications of leave-on products for eight weeks. The third control group performed skin care as usual. All participating residents were examined at baseline and after 4 and 8 weeks. Xerosis cutis was measured with the Overall Dry Skin score. Instrumental skin barrier measurements were performed at baseline and after 8 weeks. Diaries were used to document washing and skin care frequencies. Results In total, 133 residents were included and allocated to one of the three groups. Mean age was 83.8 (SD 8.3) years, 65.4% were female and most residents had care levels I (42.9%) or II (42.9%) according to the German Social Code Book XI. Mean Barthel score was 46.8 (SD 24.2) and mean Braden score was 17.6 (SD 3.7). Leg skin areas were drier compared to arms and trunk areas. At the end of the study the Overall Dry Skin scores in the intervention groups were lower compared to the control group. There were statistically significant improvements of skin dryness in both intervention groups compared to the control group over time. Conclusions The results of this pragmatic trial indicate that structured skin care regimens are effective in reducing skin dryness in aged nursing home residents within eight weeks. Trial registration The study is registered at https://clinicaltrials.gov/ct2/show/NCT02216526.

Background: Abdominal aortic aneurysms (AAA) primarily affect men over 65 years old who often have many other diseases, with similar risk factors and pathophysiological mechanisms to AAA. The aim of this study was to assess the prevalence of simple renal cysts (SRC), chronic kidney disease (CKD), and other kidney diseases (e.g. nephrolithiasis) among patients presenting with AAA. Methods: Two groups of patients (100/group), with and without AAA, from the Surgical Clinic Charité, Berlin, Germany, were selected for the study. The control group consisted of patients who were evaluated for a kidney donation (n = 14) and patients who were evaluated for an early detection of a melanoma recurrence (n = 86). The AAA and control groups were matched for age and sex. Medical records were analyzed and computed tomography scans were reviewed for the presence of SRC and nephrolithiasis. Results: SRC (73% vs. 57%; p

Background and study aims Hemostatic powders have been introduced to improve the management of gastrointestinal (GI) bleeding and to extend the variety of tools available for emergency endoscopy. The aim of the present pilot study was to evaluate the indication profiles and the short-term outcome of EndoClot. Patients, materials and methods In a prospective observational pilot study patients with acute nonvariceal GI bleeding were included. Primary or secondary application of EndoClot was assessed. Hemoglobin, prothrombine time and platelets were documented before and after hemostasis. The efficacy of EndoClot was assessed 72 hours and 1 week after application. Results Seventy patients with acute GI bleeding were recruited into the study. Eighty-three percent (58/70) of the patients had upper and 17% (12/70) had lower GI bleeding. In the upper GI tract treatment success was achieved in 64% (30/47, 95% confidence interval, 50%-76%) after primary use and in all patients, when used after established techniques had failed (95% confidence interval, 70%-100%). In lower GI bleeding hemostasis was achieved in 83% of cases (10/12, 95% confidence interval 54%-97%). Rebleeding occurred in 11% (8/70), in 10% EndoClot served as a bridge to surgery (7/70). Conclusions EndoClot expanded the therapeutic options in the management of GI bleeding. It was applicable as a monotherapy or in combination with other techniques from oozing bleeding type or lower. It was most effective in diffuse or extensive bleeding activity or when access to the bleeding vessel was difficult. EndoClot can be applied as a bridge to surgery when classical methods of hemostasis have failed.

Background The present paper aims to assess the lower threshold of vascular flow rate on the heat sink effect in bipolar radiofrequency ablation (RFA) ex vivo. Methods Glass tubes (vessels) of 3.4 mm inner diameter were introduced in parallel to bipolar RFA applicators into porcine liver ex vivo. Vessels were perfused with flow rates of 0 to 1,500 ml/min. RFA (30 W power, 15 kJ energy input) was carried out at room temperature and 37°C. Heat sink effects were assessed in RFA cross sections by the decrease in ablation radius, area and by a high-resolution sector planimetry. Results Flow rates of 1 ml/min already caused a significant cooling effect (P ≤ 0.001). The heat sink effect reached a maximum at 10 ml/min (18.4 mm/s) and remained stable for flow rates up to 1,500 ml/min. Conclusions Minimal vascular flows of ≥1 ml/min cause a significant heat sink effect in hepatic RFA ex vivo. A lower limit for volumetric flow rate was not found. The maximum of the heat sink effect was reached at a flow rate of 10 ml/min and remained stable for flow rates up to 1,500 ml/min. Hepatic inflow occlusion should be considered in RFA close to hepatic vessels.

Data regarding length of hospital stay of patients undergoing ileostomy reversal are very heterogeneous. There are many factors that may have an influence on the length of postoperative hospital stay, such as postoperative wound infections. One potential strategy to reduce their incidence and to decrease hospital stay is to insert subcutaneous suction drains. The purpose of this study was to examine the influence of the insertion of subcutaneous suction drains on hospital stay and postoperative wound infections in ileostomy reversal. Risk factors for postoperative wound infection were determined. This is a randomized controlled two-center non-inferiority trial with two parallel groups. The total length of hospital stay as primary endpoint and the occurrence of a surgical site infection, the colonization of the abdominal wall with bacteria, and the occurrence of hematomas/seromas as secondary endpoints were monitored. One hundred eighteen patients with elective ileostomy reversal were included. Fifty-nine patients were randomly assigned to insertion of a subcutaneous suction drain, and 59 patients were randomly assigned to receive no drain. After 3 months of follow-up, 50 patients in the group with drain and 53 patients in the group without drain could be analyzed. Median total length of hospital stay was 8 days in the SD group and 9 days in the group without SD (p = 0.17). Fourteen percent of patients with SD and 17 % without SD developed SSI, p = 0.68. Multivariate analysis revealed anemia (p

Background Enteroviral cardiomyopathy is a life-threatening disease, and detection of enterovirus (EV) RNA in the initial endomyocardial biopsy is associated with adverse prognosis and increased mortality. Some patients with EV infection may spontaneously eliminate the virus and recover, whereas those with virus persistence deteriorate and progress to heart failure. Interferon-beta (IFN-β) therapy eliminates the virus, resulting in increased survival of treated patients. CCR5 is expressed on antigen-presenting cells (both macrophages and dendritic cells) and immune effector cells (T-lymphocytes with memory/effector phenotype and natural killer cells). Its 32-bp deletion (CCR5del32) is the most frequent human coding sequence mutation. This study addresses the correlation of CCR5 polymorphism to the clinical course of EV infection and the necessity for IFN-β treatment. Methods We examined 97 consecutive patients with chronic/inflammatory cardiomyopathy and biopsy-proven EV infection and reliable information on clinical outcomes by CCr5 genotyping. These data were evaluated in relation to virus persistence in follow-up biopsies and survival rates over a 15-year period. Results Genotyping revealed a strong correlation between the CCR5del32 genotype and spontaneous virus clearance with improved outcomes. All patients with CCR5del32 eliminated EV spontaneously and none of them died within the observed period. In the group of untreated CCR5 wildtype patients, 33% died (Kaplan–Meier log-rank p = 0.010). However, CCR5 wildtype individuals treated with IFN-β are more likely to survive than without therapy (Kaplan–Meier log-rank p = 0.004) in identical proportions to individuals with the CCR5del32 genotype. Conclusions These data suggest that CCR5 genotyping is a novel predictive genetic marker for the clinical course of human EV cardiomyopathies. Hereby clinicians can identify those EV positive individuals who will eliminate the virus spontaneously based on CCR5 phenotype and those patients with CCR5 wildtype genotype who would be eligible for immediate antiviral IFN-β treatment to minimize irreversible cardiac damage. Electronic supplementary material The online version of this article (10.1186/s12967-018-1610-8) contains supplementary material, which is available to authorized users.