30 research outputs found

    Abdominal Wall Hernia in Complex Patients incidences, risk factors and timing of repair

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    This thesis consists of two parts: __part 1__ describes a new prosthesis for the treatment of large and complex incisional hernia. Furthermore the natural course and consequences of conservative treatment are described; __part 2__ focusses on three complex groups of patients with abdominal wall hernia. The treatment and risk factors for complications in premature infants with an inguinal hernia, kidney transplant recipients with incisional hernia, and patients with an abdominal aneurysm of the aorta are described

    Emergency repair of inguinal hernia in the premature infant is associated with high direct medical costs

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    _Purpose:_ Inguinal hernia repair is frequently performed in premature infants. Evidence on optimal management and timing of repair, as well as related medical costs is still lacking. The objective of this study was to determine the direct medical costs of inguinal hernia, distinguishing between premature infants who had to undergo an emergency procedure and those who underwent elective inguinal hernia repair. _Methods:_ This cohort study based on medical records concerned premature infants with inguinal hernia who underwent surgical repair within 3 months after birth in a tertiary academic children’s hospital between January 2010 and December 2013. Two groups were distinguished: patients with incarcerated inguinal hernia requiring emergency repair and patients who underwent elective repair. Real medical costs were calculated by multiplying the volumes of healthcare use with corresponding unit prices. Nonparametric bootstrap techniques were used to derive a 95 % confidence interval (CI) for the difference in mean costs. _Results:_ A total of 132 premature infants were included in the analysis. Emergency surgery was performed in 29 %. Costs of hospitalization comprised 65 % of all costs. The total direct medical costs amounted to €7418 per premature infant in the emergency repair group versus €4693 in the elective repair group. Multivariate analysis showed a difference in costs of €1183 (95 % CI −1196; 3044) in favor of elective repair after correction for potential risk factors. _Conclusion:_ Emergency repair of inguinal hernia in premature infants is more expensive than elective repair, even after correction for multiple confounders. This deserves to b

    Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study

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    Background and Aims: ENHANCEwas a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA).Approach and Results: Patients were randomized 1:1:1 to oral seladelpar 5 mg (n= 89), 10 mg (n= 89), placebo (n= 87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) < 1.67xupper limit of normal (ULN), >= 15% ALP decrease from baseline, and total bilirubin <= ULN] at month 12. Key secondary end points were ALP normalization at month 12 and change in pruritus numerical rating scale (NRS) at month 6 in patients with baseline score >= 4. Aminotransferases were assessed. ENHANCE was terminated early following an erroneous safety signal in a concurrent, NASH trial. While blinded, primary and secondary efficacy end points were amended to month 3. Significantly more patients receiving seladelpar met the primary end point (seladelpar 5 mg: 57.1%, 10mg: 78.2%) versus placebo (12.5%) (p < 0.0001). ALP normalization occurred in 5.4% (p= 0.08) and 27.3% (p < 0.0001) of patients receiving 5 and 10 mg seladelpar, respectively, versus 0% receiving placebo. Seladelpar 10 mg significantly reduced mean pruritus NRS versus placebo [10 mg: -3.14 (p= 0.02); placebo: -1.55]. Alanine aminotransferase decreased significantly with seladelpar versus placebo [5 mg: 23.4% (p= 0.0008); 10 mg: 16.7% (p= 0.03); placebo: 4%]. There were no serious treatment-related adverse events.Conclusions: Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated

    Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): Study protocol for a randomized controlled trial

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    Background: Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. Methods: Patients of 8 years and older undergoing appendectomy for acute complex appendicitis - defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess - are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at α 0.025). Both per-protocol and intention-to-treat analyses will be performed. Discussion: This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly

    Don’t forget about the garden! The design of gardens for people with dementia

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    Purpose: When designing a nursing home, architects and planners need to consider ways to provide patients and caregivers with a feeling of a natural setting and being a part of the outdoor world as well as considering themes such as having accessible gardens that take the total well-being of its residents1. A substantial mountain of evidence suggests that participating in green and gardening activities for people with dementia provides a positive response in such patients2-5. Experiencing the natural world and relaxing in fresh air and daylight are considered beneficial to well-being and health. The limitations of people with dementia often mean they are dependent on the people around them to provide them with opportunities to access a green environment as described above. This study focuses on the essential design needed for gardens to be enjoyed by people with dementia as part of an enriched living environment. Method: First, literature and studies providing evidence of the beneficial effect of gardening and gardens on persons with dementia were reviewed. The analysis focused on (i) the accessibility of nursing home gardens, (ii) ways we can entice people with dementia to go into the garden (independently), and (iii) ways we can motivate these people to want to stay in the garden, once they enter it. Results & Discussion: A green area offers nursing home patients, their families and caregivers many opportunities to socialize, to reminiscence and to regain an increased sense of autonomy. Therefore, encouraging people with dementia to stay in a green area more often and to participate in gardening and other activities is desirable. Caregivers can also benefit from the positive effects, such as improvements in mood and stress levels. Only limited evidence is available based on the effects of green environments on the quality of life of people with dementia, because of research limitations, small samples sizes and a lack of appropriate measurement instruments, as well as the researcher's inability to specify and define factors influencing the results, etc. Qualitative research data provide the initial guidelines for providing increased attention to the design of garden spaces and related activities. Despite the positive aspects of a garden, many Dutch nursing homes have gardens that suffer from poor accessibility. We also find that people with dementia often want to go back inside a nursing home once they enter an outdoor environment

    Innovations in multidisciplinary education in healthcare and technology

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    The growing importance of technology in health care calls for interdisciplinary study programmes in which students with various backgrounds work together in exploring and designing new solutions for real-life problems. The Centre of Healthcare and Technology of Fontys University of Applied Sciences (Fontys EGT), the Netherlands, is presented as an example of how new initiatives in the field of education at the crossroads of health care and technology can be shaped and implemented in practice. A case study illustrating one of the student projects is provided as an example of the approach to educational innovation and interdisciplinary collaboration

    Incidence, risk factors, and treatment of incisional hernia after kidney transplantation: An analysis of 1,564 consecutive patients

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    Background. The objective was to evaluate the incidence and treatment of incisional hernia after kidney transplantation and to identify potential risk factors. Methods. A retrospective cohort study was performed. All kidney transplant recipients between 2002 and 2012 were included. Two groups were identified: patients with and without incisional hernia. An analysis of risk factors for the development of incisional hernia was performed. Results. A total of 1,564 kidney recipients were included. Fifty patients (3.2%) developed incisional hernia. On univariate analysis, female sex (54 vs 35 %), body mass index (BMI) >30 kg/m(2) (38 vs 17%), concurrent abdominal wall hernia (30 vs 16%), multiple explorations of the ipsilateral iliac fossa (38 vs 19%), left iliac fossa implantation (36 vs 24%), history of smoking (72 vs 57%), and duration of the kidney transplantation procedure (210 vs 188 minutes) were associated with the development of incisional hernia (P30; HR 2.9), multiple explorations of the ipsilateral iliac fossa (HR 2.0), duration of operation (HR 1.007), and concurrent abdominal wall hernia (HR 2.3) were independent risk factors. Twenty-six of 50 patients (52%) underwent operative repair, of whom 9 (35 %) required emergency repair. Conclusion. The incidence of incisional hernia after kidney transplantation with a median follow-up of 59 months is 3.2%. Obesity (BAIT >30), female sex, concurrent abdominal wall hernias, history of smoking, duration of surgery, and multiple explorations were independent risk factors for the development of incisional hernia after kidney transplantation. Attempts at preventing incisional hernias based on these risk factors should be explored
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