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  • 1
    Online Resource
    Online Resource
    Quality of Life after Desarda Technique for Inguinal Hernia Repair—A Comparative Retrospective Multicenter Study of 120 Patients
    MDPI AG ; 2023
    In:  Journal of Clinical Medicine Vol. 12, No. 3 ( 2023-01-28), p. 1001-
    Details
    In: Journal of Clinical Medicine, MDPI AG, Vol. 12, No. 3 ( 2023-01-28), p. 1001-
    Abstract: Inguinal hernia repair, according to Desarda, is a pure tissue surgical technique using external oblique fascia to reinforce the posterior wall of the inguinal canal. This has provided an impetus for the rethinking of guideline adherence toward minimally invasive and mesh-based surgery of inguinal hernia. In this study, a retrospective analysis of this technique was conducted in two German hospitals. Between 6/2013 and 12/2020, 120 operations were performed. Analysis included patient characteristics, duration of operation, length of hospital stay, and perioperative complications. Data were used to achieve a matched-pair analysis comparing Desarda to laparoscopic transabdominal preperitoneal (TAPP) hernia repair. Propensity scores were calculated based on five preoperative variables, including sex, age, American Society of Anesthesiology classification, localization, and width of the inguinal hernia in order to achieve comparability. Additionally, we assessed pain level and quality of life (QoL) 12 months postoperatively. The focus of our study was a comparison of QoL to a reference population and TAPP cohort. The study population consisted of 106 male and 14 female patients, and the median age was 37.5 years. The median operation time was 50 min, and the median length of hospital stay was 2 days. At a follow-up of 17 months, the median recurrence rate was 0.8%, and two cases of chronic postoperative pain were recorded. Postoperative QoL does not significantly differ between Desarda and TAPP. In contrast, Desarda patients had a significantly higher QoL compared with the reference population. In summary, Desarda’s procedure is a good option as a pure tissue method for inguinal hernia repair.
    Type of Medium: Online Resource
    ISSN: 2077-0383
    URL: Article
    DOI: 10.3390/jcm12031001
    Language: English
    Publisher: MDPI AG
    Publication Date: 2023
    detail.hit.zdb_id: 2662592-1
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  • 2
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    Evaluation of Hyperspectral Imaging for Follow-Up Assessment after Revascularization in Peripheral Artery Disease
    MDPI AG ; 2022
    In:  Journal of Clinical Medicine Vol. 11, No. 3 ( 2022-01-30), p. 758-
    Details
    In: Journal of Clinical Medicine, MDPI AG, Vol. 11, No. 3 ( 2022-01-30), p. 758-
    Abstract: Background: Assessment of tissue oxygenation is an important aspect of detection and monitoring of patients with peripheral artery disease (PAD). Hyperspectral imaging (HSI) is a non-contact technology for assessing microcirculatory function by quantifying tissue oxygen saturation (StO2). This study investigated whether HSI can be used to monitor skin oxygenation in patients with PAD after appropriate treatment of the lower extremities. Methods: For this purpose, 37 patients with PAD were studied by means of ankle–brachial index (ABI) and HSI before and after surgical or endovascular therapy. Thereby, the oxygenation parameter StO2 and near infrared (NIR) perfusion index were quantified in seven angiosomes on the diseased lower leg and foot. In addition, the effects of skin temperature and physical activity on StO2 and the NIR perfusion index and the respective inter-operator variability of these parameters were investigated in 25 healthy volunteers. Results: In all patients, the ABI significantly increased after surgical and endovascular therapy. In parallel, HSI revealed significant changes in both StO2 and NIR perfusion index in almost all studied angiosomes depending on the performed treatment. The increase in tissue oxygenation saturation was especially pronounced after surgical treatment. Neither heat nor cold, nor physical activity, nor repeated assessments of HSI parameters by independent investigators significantly affected the results on StO2 and the NIR perfusion index. Conclusions: Tissue oxygen saturation data obtained with HSI are robust to external confounders, such as temperature and physical activity, and do not show inter-operator variability; therefore, can be used as an additional technique to established methods, such as the ABI, to monitor peripheral perfusion in patients with PAD.
    Type of Medium: Online Resource
    ISSN: 2077-0383
    URL: Article
    DOI: 10.3390/jcm11030758
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2662592-1
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  • 3
    Online Resource
    Online Resource
    Emigration Rates From Sample Surveys: An Application to Senegal
    Duke University Press ; 2017
    In:  Demography Vol. 54, No. 6 ( 2017-12-01), p. 2159-2179
    Details
    In: Demography, Duke University Press, Vol. 54, No. 6 ( 2017-12-01), p. 2159-2179
    Abstract: What is the emigration rate of a country, and how reliable is that figure? Answering these questions is not at all straightforward. Most data on international migration are census data on foreign-born population. These migrant stock data describe the immigrant population in destination countries but offer limited information on the rate at which people leave their country of origin. The emigration rate depends on the number leaving in a given period and the population at risk of leaving, weighted by the duration at risk. Emigration surveys provide a useful data source for estimating emigration rates, provided that the estimation method accounts for sample design. In this study, emigration rates and confidence intervals are estimated from a sample survey of households in the Dakar region in Senegal, which was part of the Migration between Africa and Europe survey. The sample was a stratified two-stage sample with oversampling of households with members abroad or return migrants. A combination of methods of survival analysis (time-to-event data) and replication variance estimation (bootstrapping) yields emigration rates and design-consistent confidence intervals that are representative for the study population.
    Type of Medium: Online Resource
    ISSN: 0070-3370 , 1533-7790
    URL: Article
    DOI: 10.1007/s13524-017-0622-y
    Language: English
    Publisher: Duke University Press
    Publication Date: 2017
    detail.hit.zdb_id: 280612-5
    detail.hit.zdb_id: 2010091-7
    SSG: 3,4
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  • 4
    Online Resource
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    Medical Device Regulation and current challenges for the implementation of new technologies
    Walter de Gruyter GmbH ; 2020
    In:  Current Directions in Biomedical Engineering Vol. 6, No. 3 ( 2020-09-01), p. 334-337
    Details
    In: Current Directions in Biomedical Engineering, Walter de Gruyter GmbH, Vol. 6, No. 3 ( 2020-09-01), p. 334-337
    Abstract: The European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a proposal to postpone the application for one year to relieve pressure from all stakeholders allowing them to fully focus on priorities related to the coronavirus crisis. From this date or most likely from May 26, 2021, manufacturers must present a CE-certificate according to the new MDR requirements not only for novel medical devices, but also for approved medical devices which are already on the market. The MDR will significantly complicate the process of bringing medical devices into market due to the increased requirements for the CE-certification process, particularly concerning increased documentation effort. This involves a risk for the translation of innovative products due to an overload of the overall system (manufacturers, Notified Bodies, experts) and might lead to shrinkage of the product range of existing products. Thankfully, adaption of transitional periods, special regulations, extensions of deadlines and most probably postponement of the MDR application date will ensure that there will be no gaps in medical supply that endanger patients. Establishing and keeping the relevant regulatory expertise up to date and devoting the necessary financial, time and human resources that is the biggest immediate challenge the medium-sized medical technology sector is facing in the near future. The current article, written about one month before the initially expected end of the first transition period on May 26, 2020, summarized the main aspects of the current state of MDR implementation with respect to regulatory novelties, the current legal basis in Germany, transition periods and changes in the requirements of CE-certification relevant technical documentation. Furthermore, challenges for existing and innovative medical devices were shortly discussed using a new stent based therapy of the proximal Fallopian tubal stenosis and transcatheter aortic valve implantation as two examples.
    Type of Medium: Online Resource
    ISSN: 2364-5504
    URL: Article
    DOI: 10.1515/cdbme-2020-3086
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2020
    detail.hit.zdb_id: 2835398-5
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  • 5
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    Online Resource
    Randomized Registry Trials - efficient post market clinical follow-up for medical devices
    Walter de Gruyter GmbH ; 2023
    In:  Current Directions in Biomedical Engineering Vol. 9, No. 1 ( 2023-09-01), p. 487-490
    Details
    In: Current Directions in Biomedical Engineering, Walter de Gruyter GmbH, Vol. 9, No. 1 ( 2023-09-01), p. 487-490
    Abstract: In spite of advances in the treatment of cardiovascular disease, there remains a significant need for high-quality evidence for clinical practice given the rising prevalence worldwide. Next to the increase of regulatory requirements, poor screening-to-recruitment ratios, lack of patient engagement, and long timelines for contracting and institutional review board (IRB) approval are leading to an outflow of clinical trials in the EU. Patient registries are a potentially rich source of data, especially for evaluating the course of rare diseases and effects of new treatments. In the sectors of regulatory assessments of medical devices they are greatly underused. Health-related real world data provide crucial support for regulatory decision-making, particularly post-market assessments of medical products. Registries can be used not only for observational studies, but also for conducting experimental study designs. Register-based randomized controlled trials (RRCTs) are of particular importance here, as they can combine the advantages of randomized controlled trials (RCT) and registers. The government's financial support and reduction of regulatory barriers to the implementation of registry-based RCT are incentive factors for manufacturers to let their medical devices (re-)certified. Furthermore, it is essential that the necessary criteria are already taken into account when setting up the German implant registry in order to enable future RRCTs. The presented work is an additional pleading for the use and extension of registries for all medical products.
    Type of Medium: Online Resource
    ISSN: 2364-5504
    URL: Article
    DOI: 10.1515/cdbme-2023-1122
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 2835398-5
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  • 6
    Online Resource
    Online Resource
    Quality of Life after Complex Abdominal Wall Reconstruction
    S. Karger AG ; 2020
    In:  Visceral Medicine Vol. 36, No. 4 ( 2020), p. 326-332
    Details
    In: Visceral Medicine, S. Karger AG, Vol. 36, No. 4 ( 2020), p. 326-332
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Component separation (CS) for tension-free approximation of fascial edges is the established technique for the repair of large ventral hernias mostly regarding midline defects. Recent studies suggest lower complication rates following a modified version of this technique using a partially endoscopic-assisted approach, whereas little is known about the quality of life (QoL) in the long-term evaluation of these patients. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 A retrospective study and analysis of patients undergoing hernia repair using an open CS (OCS) and endoscopically assisted CS (ECS) technique, respectively, from 2011 to 2016 at the Rostock University Medical Center. Patients underwent a mesh-based sublay reinforcement following a distinct CS with closure of the linea alba. Patient characteristics, technical details, and short-term postoperative outcomes were determined by a physician chart review. A health-related QoL survey (EQ-5D) including a pain assessment was evaluated at a median of 19.5 months postoperatively. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Thirty-five patients had a CS: 25 OCS and 10 ECS. Perioperative variables were comparable except for the median defect size (169 cm 〈 sup 〉 2 〈 /sup 〉 OCS vs. 86 cm 〈 sup 〉 2 〈 /sup 〉 ECS; 〈 i 〉 p 〈 /i 〉 & #x3c; 0.05) and maximum width of hernia (25 vs. 13 cm). Hospitalization lasted 16.6 days in the OCS group and 7.9 days in the endoscopic group ( 〈 i 〉 p 〈 /i 〉 = 0.04). Wound complications occurred in 24% of OCS and 10% of ECS patients. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 Patients in the ECS group had a shorter hospital stay and less minor and major wound complications. These advantages led to a faster recovery directly affecting the QoL in the ECS group. This effect diminishes in the long-term follow-up with a positive trend towards the OCS technique.
    Type of Medium: Online Resource
    ISSN: 2297-4725 , 2297-475X
    URL: Article
    DOI: 10.1159/000505247
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2020
    detail.hit.zdb_id: 2850734-4
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  • 7
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    Development of a testing device for external wrist bridging dynamic fixators used for distal radius fractures
    Elsevier BV ; 2023
    In:  Clinical Biomechanics Vol. 108 ( 2023-08), p. 106056-
    Details
    In: Clinical Biomechanics, Elsevier BV, Vol. 108 ( 2023-08), p. 106056-
    Type of Medium: Online Resource
    ISSN: 0268-0033
    URL: Article
    DOI: 10.1016/j.clinbiomech.2023.106056
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
    detail.hit.zdb_id: 2004518-9
    SSG: 31
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  • 8
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    Online Resource
    Use of incisional preventive negative pressure wound therapy in open incisional hernia repair: Who benefits?
    Wiley ; 2021
    In:  Wound Repair and Regeneration Vol. 29, No. 5 ( 2021-09), p. 759-765
    Details
    In: Wound Repair and Regeneration, Wiley, Vol. 29, No. 5 ( 2021-09), p. 759-765
    Abstract: Complex surgery of abdominal wall hernia continues to bear the major concern of wound healing disorders. Technical modifications have not been able to sufficiently prevent wound healing impairments or infections, even in clean elective cases, especially when dealing with large‐scale hernia defects. Incisional negative pressure wound therapy (iNPWT) in its intentional use as a preventive tool has recently found its way from theoretical and experimental advantages to the clinical routine. Different indications have been defined but evidence is lacking. We performed a retrospective analysis (1/2014–5/2019) of all ventral hernia repairs ( n  = 386) done in our institution as open sublay mesh reinforcement, partially requiring component separation (CS), receiving iNPWT in selected cases based on single surgeon experience. Pre‐ and perioperative data included patient and hernia characteristics as well as the employed mesh sizes. Postoperative follow‐up (median 38.5 months [interquartile range: 23.4, 53.3]) extended beyond patient dismissal and included the rate of re‐admission due to wound healing disorders. The primary outcome was the incidence of surgical site occurrences (SSO). Secondary endpoints included wound‐related readmissions, reoperations and recurrences. Patients were matched based on propensity scores in a 1:1 ratio. Propensity scores were calculated based on five preoperative variables, including sex, body‐mass‐index, American Society of Anesthesiology classification, recurrent hernia repair and operation technique, to identify significant parameters. The rate of SSO was 12% ( n  = 46) for all operated cases, and the rate of surgical site infection (SSI) was 8.8% ( n  = 34). In the subgroup of CS ( n  = 40), the rate increased to 15% ( n  = 6). The usage of iNPWT ( n  = 54) led to an in‐hospital SSO rate of 14.8% ( n  = 8) but increased to 33.3% ( n  = 18) when including the re‐admission rate. The SSI rate for the iNPWT cohort was 14.8% ( n  = 8) with a consecutive need for reoperation (Clavien‐Dindo IIIb) in 87.5% ( n  = 7). In the matched‐pair analysis, the hernia‐size and mesh‐size were the main risk factors for SSO. The use of iNPWT significantly reduced this statistical effect ( p  = 0.405). In a large and representative patient cohort, we were able to demonstrate that the advantage of iNPWT used after complex abdominal wall repair does not come first hand. Especially in the follow‐up, we found a relevant increase in wound healing problems after dismissal. To proof the benefit of iNPWT in these heterogeneous patients, we could identify hernia size and mesh size as individual risk factors that were nihilated by the use of iNPWT. We found it to be favourable to use iNPWT when mesh‐size exceeded 450 cm 2 .
    Type of Medium: Online Resource
    ISSN: 1067-1927 , 1524-475X
    URL: Issue
    URL: Article
    DOI: 10.1111/wrr.v29.5
    DOI: 10.1111/wrr.12948
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2011990-2
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  • 9
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    Integrated Biobanking and Tumor Model Establishment of Human Colorectal Carcinoma Provides Excellent Tools for Preclinical Research
    MDPI AG ; 2019
    In:  Cancers Vol. 11, No. 10 ( 2019-10-09), p. 1520-
    Details
    In: Cancers, MDPI AG, Vol. 11, No. 10 ( 2019-10-09), p. 1520-
    Abstract: Over the time period from 2006 to 2017, consecutive patients operated on at the University Medical Center Rostock participated in the comprehensive biobanking and tumor-modelling approach known as the HROC collection. Samples were collected using strict standard operating procedures including blood (serum and lymphocytes), tumor tissue (vital and snap frozen), and adjacent normal epithelium. Patient and tumor data including classification, molecular type, clinical outcome, and results of the model establishment are the essential pillars. Overall, 149 patient-derived xenografts with 34 primary and 35 secondary cell lines were successfully established and encompass all colorectal carcinoma anatomic sites, grading and staging types, and molecular classes. The HROC collection represents one of the largest model assortments from consecutive clinical colorectal carcinoma (CRC) cases worldwide. Statistical analysis identified a variety of clinicopathological and molecular factors associated with model success in univariate analysis. Several of them not identified before include localization, mutational status of K-Ras and B-Raf, MSI-status, and grading and staging parameters. In a multivariate analysis model, success solely correlated positively with the nodal status N1 and mutations in the genes K-Ras and B-Raf. These results imply that generating CRC tumor models on the individual patient level is worth considering especially for advanced tumor cases with a dismal prognosis.
    Type of Medium: Online Resource
    ISSN: 2072-6694
    URL: Article
    DOI: 10.3390/cancers11101520
    Language: English
    Publisher: MDPI AG
    Publication Date: 2019
    detail.hit.zdb_id: 2527080-1
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  • 10
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    Die Medical Device Regulation nach Geltungsbeginn: Wie können Gestaltungsspielräume zur Praktikabilität genutzt werden?
    Georg Thieme Verlag KG ; 2023
    In:  Zentralblatt für Chirurgie - Zeitschrift für Allgemeine, Viszeral-, Thorax- und Gefäßchirurgie Vol. 148, No. 03 ( 2023-06), p. 187-191
    Details
    In: Zentralblatt für Chirurgie - Zeitschrift für Allgemeine, Viszeral-, Thorax- und Gefäßchirurgie, Georg Thieme Verlag KG, Vol. 148, No. 03 ( 2023-06), p. 187-191
    Type of Medium: Online Resource
    ISSN: 0044-409X , 1438-9592
    URL: Article
    DOI: 10.1055/a-2079-4967
    Language: German
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2023
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