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De Haan J.,Westfriesgasthuis | Schep N.W.L.,Rotterdam University | Tuinebreijer W.E.,Rotterdam University | Patka P.,Rotterdam University | Den Hartog D.,Rotterdam University
Archives of Orthopaedic and Trauma Surgery | Year: 2010

Objective: To identify if functional treatment is the best available treatment for simple elbow dislocations. Search strategy Electronic databases MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials. Selection criteria Studies were eligible for inclusion if they were trials comparing different techniques for the treatment of simple elbow dislocations. Data analysis Results: were expressed as relative risk for dichotomous outcomes and weighted mean difference for continuous outcomes with 95% confidence intervals. Main results This review has included data from two trials and three observational comparative studies. Important data were missing from three observational comparative studies and the results from these studies were extracted for this review. No difference was found between surgical treatment of the collateral ligaments and plaster immobilisation of the elbow joint. Better range of movement, less pain, better functional scores, shorter disability and shorter treatment time were seen after functional treatment versus plaster immobilisation. © 2009 Springer-Verlag. Source

Wagener G.,Genzyme | Baker B.F.,Isis Pharmaceuticals | Geary R.S.,Isis Pharmaceuticals | Donovan J.M.,Genzyme | Basart D.C.G.,Westfriesgasthuis
European Heart Journal | Year: 2012

Aims A randomized, double-blind, placebo-controlled study was conducted to investigate the safety and efficacy of mipomersen, an apolipoprotein B-100 (apoB) synthesis inhibitor, in patients who are statin intolerant and at high risk for cardiovascular disease (CVD). Methods and resultsThirty-three subjects, not receiving statin therapy because of statin intolerance, received a weekly subcutaneous dose of 200 mg mipomersen or placebo (2:1 randomization) for 26 weeks. The primary endpoint was per cent change in LDL cholesterol (LDL-c) from the baseline to Week 28. The other efficacy endpoints were per cent change in apoB and lipoprotein a [Lp(a)]. Safety was determined using the incidence of treatment-emergent adverse events (AEs) and clinical laboratory evaluations. After 26 weeks of mipomersen administration, LDL-c was reduced by 47 ± 18 (P < 0.001 vs. placebo). apoB and Lp(a) were also significantly reduced by 46 and 27, respectively (P < 0.001 vs. placebo). Four mipomersen (19) and two placebo subjects (17) discontinued dosing prematurely due to AEs. Persistent liver transaminase increases <3× the upper limit of normal were observed in seven (33) subjects assigned to mipomersen. In selected subjects, liver fat content was assessed, during and after treatment, using magnetic resonance spectroscopy. Liver fat content in these patients ranged from 0.8 to 47.3. Liver needle biopsy was performed in two of these subjects, confirming hepatic steatosis with minimal inflammation or fibrosis. ConclusionThe present data suggest that mipomersen is a potential therapeutic option in statin-intolerant patients at high risk for CVD. The long-term follow-up of liver safety is required.Clinical Trial Registration: ClinicalTrials.gov identifier: NCT00707746 Published on behalf of the European Society of Cardiology. © The Author 2012. Source

Iordens G.I.T.,Rotterdam University | Den Hartog D.,Rotterdam University | Van Lieshout E.M.M.,Rotterdam University | Tuinebreijer W.E.,Rotterdam University | And 4 more authors.
Clinical Orthopaedics and Related Research | Year: 2015

Background: After a complex dislocation, some elbows remain unstable after closed reduction or fracture treatment. Function after treatment with a hinged external fixator theoretically allows collateral ligaments to heal without surgical reconstruction. However, there is a lack of prospective studies that assess functional outcome, pain, and ROM. Questions/purposes: We asked: (1) In complex elbow fracture-dislocations, does treatment with a hinged external fixator result in reduction of disability and pain, and in improvement in ROM, function, and quality of life? (2) Does delayed treatment (7 days or later) have a negative effect on ROM after 1 year? (3) What are the complications seen after external fixator treatment? Methods: During a 2-year period, 11 centers recruited 27 patients 18 years or older who were included and evaluated at 2 and 6 weeks and at 3, 6, and 12 months after surgery as part of this prospective case series. During the study period, the participating centers agreed on general indications for use of the hinged external fixator, which included persistent instability after closed reduction alone or closed reduction combined with surgical treatment of associated fracture(s), when indicated. Functional outcome was evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH; primary outcome) score, the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score, and the level of pain (VAS). ROM, adverse events, secondary interventions, and radiographs also were evaluated. A total of 26 of the 27 patients (96%) were available for followup at 1 year. Results: All functional and pain scores improved. The median QuickDASH score decreased from 30 (25th–75th percentiles [P25–P75], 23–40) at 6 weeks to 7 (P25–P75, 2–12) at 1 year with a median difference of −25 (p < 0.001). The median MEPI score increased from 80 (P25–P75, 64–85) at 6 weeks to 100 (P25–P75, 85–100) at 1 year with a median difference of 15 (p < 0.001). The median Oxford Elbow Score increased from 60 (P25–P75, 44–68) at 6 weeks to 90 (P25–P75, 73–96) at 1 year with a median difference of 29 (p < 0.001). The median VAS decreased from 2.8 (P25–P75, 1.0–5.0) at 2 weeks to 0.5 (P25–P75, 0.0–1.9) at 1 year with a median difference of −2.1 (p = 0.001). ROM also improved. The median flexion-extension arc improved from 50° (P25–P75, 33°–80°) at 2 weeks to 118° (P25–P75, 105°–138°) at 1 year with a median difference of 63° (p < 0.001). Similarly, the median pronation-supination arc improved from 90° (P25–P75, 63°–124°) to 160° (P25–P75, 138°–170°) with a median difference of 75° (p < 0.001). At 1 year, the median residual deficit compared with the uninjured side was 30° (P25–P75, 5°–35°) for the flexion-extension arc, and 3° (P25–P75, 0°–25°) for the pronation-supination arc. Ten patients (37%) experienced a fixator-related complication, and seven patients required secondary surgery (26%). One patient reported recurrent instability. Conclusions: A hinged external elbow fixator provides enough stability to start early mobilization after an acute complex elbow dislocation and residual instability. This was reflected in good functional outcome scores and only slight disability despite a relatively high complication rate. Level of Evidence: Level IV, therapeutic study. © 2014, The Association of Bone and Joint Surgeons®. Source

van Drie C.E.,Westfriesgasthuis
Nederlands tijdschrift voor geneeskunde | Year: 2013

A 47-year-old man presented to the emergency department with a rapidly progressive, generalized rash and pustulosis shortly after he had started amoxicillin/clavulanic acid for the treatment of a pulmonary infection. Based on the patient's history and the clinical symptoms, the diagnosis of 'acute generalized exanthematous pustulosis' (AGEP) was suspected. This was confirmed by histopathological examination. The skin abnormalities slowly disappeared after terminating antibiotic medication. Source

Vennix S.,Erasmus Medical Center | Mulder I.M.,Erasmus Medical Center | Consten E.C.,Meander Medical Center | Belgers E.H.,Atrium Medical | And 10 more authors.
The Lancet | Year: 2015

Background Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. Methods We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≤20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≤60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. Findings Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). Interpretation Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. Funding Netherlands Organisation for Health Research and Development. © 2015 Elsevier Ltd. Source

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