Romberg-Camps M.,Maastricht University |
Kuiper E.,Erasmus Medical Center |
Schouten L.,Maastricht University |
Kester A.,Maastricht University |
And 9 more authors.
Inflammatory Bowel Diseases | Year: 2010
Background: The aim was to evaluate overall and disease-specific mortality in a population-based inflammatory bowel disease (IBD) cohort in the Netherlands, as well as risk factors for mortality. Methods: IBD patients diagnosed between 1 January 1991 and 1 January 2003 were included. Standardized mortality ratios (SMRs) were calculated overall and with regard to causes of death, gender, as well as age, phenotype, smoking status at diagnosis, and medication use. Results: At the censoring date, 72 out of 1187 patients had died (21 Crohn's disease [CD], 47 ulcerative colitis [UC], and 4 indeterminate colitis [IC] patients). The SMR (95% confidence interval [CI]) was 1.1 (0.7-1.6) for CD, 0.9 (0.7-1.2) for UC and 0.7 (0.2-1.7) for IC. Disease-specific mortality risk was significantly increased for gastrointestinal (GI) causes of death both in CD (SMR 7.5, 95% CI: 2.8-16.4) and UC (SMR 3.4, 95% CI: 1.4-7.0); in CD patients, especially in patients <40 years of age at diagnosis. For UC, an increased SMR was noted in female patients and in patients <19 years and >80 years at diagnosis. In contrast, UC patients had a decreased mortality risk from cancer (SMR 0.5, 95% CI; 0.2-0.9). Conclusions: In this population-based IBD study, mortality in CD, UC, and IC was comparable to the background population. The increased mortality risk for GI causes might reflect complicated disease course, with young and elderly patients at diagnosis needing intensive follow-up. Caution in interpreting the finding on mortality risk from cancer is needed as follow-up was probably to short to observe IBD-related cancers. Copyright © 2009 Crohn's & Colitis Foundation of America, Inc.
Efficacy of vitamin D3 as add-on therapy in patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, double-blind, randomized, placebo-controlled trial
Smolders J.,Maastricht University |
Hupperts R.,Orbis Medical Center Sittard |
Barkhof F.,VU University Amsterdam |
Grimaldi L.M.E.,Fondazione Instituto San Raffaele G Giglio Of Cefalu |
And 10 more authors.
Journal of the Neurological Sciences | Year: 2011
Recent studies have demonstrated the immunomodulatory properties of vitamin D, and vitamin D deficiency may be a risk factor for the development of MS. The risk of developing MS has, in fact, been associated with rising latitudes, past exposure to sun and serum vitamin D status. Serum 25-hydroxyvitamin D [25(OH)D] levels have also been associated with relapses and disability progression. The identification of risk factors, such as vitamin D deficiency, in MS may provide an opportunity to improve current treatment strategies, through combination therapy with established MS treatments. Accordingly, vitamin D may play a role in MS therapy. Small clinical studies of vitamin D supplementation in patients with MS have reported positive immunomodulatory effects, reduced relapse rates and a reduction in the number of gadolinium-enhancing lesions. However, large randomized clinical trials of vitamin D supplementation in patients with MS are lacking. SOLAR (Supplementation of VigantOL® oil versus placebo as Add-on in patients with relapsing-remitting multiple sclerosis receiving Rebif® treatment) is a 96-week, three-arm, multicenter, double-blind, randomized, placebo-controlled, Phase II trial (NCT01285401). SOLAR will evaluate the efficacy of vitamin D3 as add-on therapy to subcutaneous interferon beta-1a in patients with RRMS. Recruitment began in February 2011 and is aimed to take place over 1 calendar year due to the potential influence of seasonal differences in 25(OH)D levels. © 2011 Elsevier B.V. All rights reserved.
Romberg-Camps M.J.L.,Maastricht University |
Bol Y.,Orbis Medical Center |
Bol Y.,Maastricht University |
Dagnelie P.C.,Maastricht University |
And 9 more authors.
Inflammatory Bowel Diseases | Year: 2010
Background: The importance of fatigue in chronic disease has been increasingly recognized; however, little is known about fatigue in inflammatory bowel disease (IBD). The aim of the present study was to investigate the prevalence and severity of fatigue and the impact on health-related quality of life (HRQoL) in patients included in a population-based IBD cohort in the Netherlands. Methods: IBD patients, diagnosed between January 1st, 1991, and January 1st, 2003, were followed up for a median of 7.1 years. They completed a questionnaire, which included a disease activity score, the Multidimensional Fatigue Inventory (MFI-20), the Inflammatory Bowel Disease Questionnaire (IBDQ), and the Short Form health survey (SF-36). Hemoglobin levels were recorded. Results: Data were available in 304 Crohn's disease (CD), 368 ulcerative colitis (UC), and 35 indeterminate colitis (IC) patients. During quiescent disease, the prevalence of fatigue was nearly 40%. MFI-20 and HRQoL scores were significantly worse in IBD patients having active disease. In a multivariate analysis, disease activity was positively related with the level of fatigue in both CD and UC. In UC, anemia influenced the general fatigue score independently of disease activity. Disease activity as well as fatigue were independently associated with an impaired IBDQ. Conclusions: In IBD, even in remission, fatigue is an important feature. Both in CD and in UC, fatigue determined HRQoL independently of disease activity or anemia. This implies that in IBD patients physicians need to be aware of fatigue in order to better understand its impact and to improve the HRQoL. Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.
PubMed | FLENI Buenos Aires, INEBA Buenos Aires, New York University, University of Chieti Pescara and 26 more.
Type: Journal Article | Journal: Annals of clinical and translational neurology | Year: 2015
To assess demographic, clinical, magnetic resonance imaging, and treatment exposure predictors of time to 3 or 12-month confirmed disability worsening in clinically isolated syndrome (CIS) and early multiple sclerosis (MS).We utilized the MSBase Incident Study (MSBasis), a prospective cohort study of outcome after CIS. Predictors of time to first 3 and 12-month confirmed expanded disability status scale worsening were analyzed using Cox proportional hazards regression.About 1989 patients were analyzed, the largest seen-from-onset cohort reported to-date. A total of 391 patients had a first 3-month confirmed disability worsening event, of which 307 were sustained for 12 months. Older age at CIS onset (adjusted hazard ratio: aHR 1.17, 95% 1.06, 1.30), pyramidal (aHR 1.45, 95% CI 1.13, 1.89) and ambulation (HR 1.60, 95% CI 1.09, 2.34) system dysfunction, annualized relapse rate (aHR 1.20, 95% CI 1.18, 1.22), and lower proportion of observation time on treatment were associated with 3-month confirmed worsening. Predictors of time to 12-month sustained worsening included pyramidal system dysfunction (Hazard ratio: aHR 1.38, 95% CI 1.05, 1.83), and older age at CIS onset (aHR 1.17, 95% CI 1.04, 1.31). Greater proportion of follow-up time exposed to treatment was associated with greater reductions in the rate of worsening.This study provides class IV evidence for a strong protective effect of disease-modifying treatment to reduce disability worsening events in patients with CIS and early MS, and confirms age and pyramidal dysfunction at onset as risk factors.
Investigating the performance and cost-effectiveness of the simple ultrasound-based rules compared to the risk of malignancy index in the diagnosis of ovarian cancer (SUBSONiC-study): protocol of a prospective multicenter cohort study in the Netherlands
PubMed | Laurentius Ziekenhuis Roermond, VieCuri Venlo, Maastricht University, Orbis Medical Center Sittard and St. Jans Gasthuis Weert
Type: | Journal: BMC cancer | Year: 2015
Estimating the risk of malignancy is essential in the management of adnexal masses. An accurate differential diagnosis between benign and malignant masses will reduce morbidity and costs due to unnecessary operations, and will improve referral to a gynecologic oncologist for specialized cancer care, which improves outcome and overall survival. The Risk of Malignancy Index is currently the most commonly used method in clinical practice, but has a relatively low diagnostic accuracy (sensitivity 75-80% and specificity 85-90%). Recent reports show that other methods, such as simple ultrasound-based rules, subjective assessment and (Diffusion Weighted) Magnetic Resonance Imaging might be superior to the RMI in the pre-operative differentiation of adnexal masses.A prospective multicenter cohort study will be performed in the south of The Netherlands. A total of 270 women diagnosed with at least one pelvic mass that is suspected to be of ovarian origin who will undergo surgery, will be enrolled. We will apply the Risk of Malignancy Index with a cut-off value of 200 and a two-step triage test consisting of simple ultrasound-based rules supplemented -if necessary- with either subjective assessment by an expert sonographer or Magnetic Resonance Imaging with diffusion weighted sequences, to characterize the adnexal masses. The histological diagnosis will be the reference standard. Diagnostic performances will be expressed as sensitivity, specificity, positive and negative predictive values and likelihood ratios.We hypothesize that this two-step triage test, including the simple ultrasound-based rules, will have better diagnostic accuracy than the Risk of Malignancy Index and therefore will improve the management of women with adnexal masses. Furthermore, we expect this two-step test to be more cost-effective. If the hypothesis is confirmed, the results of this study could have major effects on current guidelines and implementation of the triage test in daily clinical practice could be a possibility.ClinicalTrials.gov: registration number NCT02218502.
Le Clercq C.M.C.,Maastricht University |
Winkens B.,Maastricht University |
Bakker C.M.,Atrium Medical |
Keulen E.T.P.,Orbis Medical Center Sittard |
And 3 more authors.
Gastrointestinal Endoscopy | Year: 2015
Background Several studies examined the rate of colorectal cancer (CRC) developed during colonoscopy surveillance after CRC resection (ie, metachronous CRC [mCRC]), yet the underlying etiology is unclear. Objective To examine the rate and likely etiology of mCRCs. Design Population-based, multicenter study. Review of clinical and histopathologic records, including data of the national pathology database and The Netherlands Cancer Registry. Setting National cancer databases reviewed at 3 hospitals in South-Limburg, The Netherlands. Patients Total CRC population diagnosed in South-Limburg from January 2001 to December 2010. Interventions Colonoscopy. Main Outcome Measurements We defined an mCRC as a second primary CRC, diagnosed >6 months after the primary CRC. By using a modified algorithm to ascribe likely etiology, we classified the mCRCs into cancers caused by non-compliance with surveillance recommendations, inadequate examination, incomplete resection of precursor lesions (CRC in same segment as previous advanced adenoma), missed lesions, or newly developed cancers. Results We included a total of 5157 patients with CRC, of whom 93 (1.8%) had mCRCs, which were diagnosed on an average of 81 months (range 7-356 months) after the initial CRC diagnosis. Of all mCRCs, 43.0% were attributable to non-compliance with surveillance advice, 43.0% to missed lesions, 5.4% to incompletely resected lesions, 5.4% to newly developed cancers, and 3.2% to inadequate examination. Age-adjusted and sex-adjusted logistic regression analyses showed that mCRCs were significantly smaller in size (odds ratio [OR] 0.8; 95% confidence interval [CI], 0.7-0.9) and more often poorly differentiated (OR 1.7; 95% CI, 1.0-2.8) than were solitary CRCs. Limitations Retrospective evaluation of clinical data. Conclusion In this study, 1.8% of all patients with CRC developed mCRCs, and the vast majority were attributable to missed lesions or non-compliance with surveillance advice. Our findings underscore the importance of high-quality colonoscopy to maximize the benefit of post-CRC surveillance. © 2015 American Society for Gastrointestinal Endoscopy.
Gehlen J.M.L.G.,Admiraal de Ruyter Ziekenhuis Goes Vlissingen |
Heeren P.A.M.,Orbis Medical Center Sittard |
Verhagen P.F.,Admiraal de Ruyter Ziekenhuis Goes Vlissingen |
Peppelenbosch A.G.,Maastricht University
Vascular and Endovascular Surgery | Year: 2011
Visceral artery aneurysms (VAAs) are a rare condition, in case of a rupture they have a high mortality rate up to 70%. Visceral artery aneurysms are seen more often these days with the more widespread use of computed tomography and angiography. There are various options for treating VAAs; open surgical repair, endovascular treatment, and laparoscopic surgery. We report 5 cases of visceral aneurysms, all treated differently-ligation, aneurysmectomy (with splenectomy), emergency and elective coil embolization, and conservatively. We will further give a review of the literature on etiology, diagnosis, and treatment options. © SAGE Publications 2011.
PubMed | Atrium Medical, Maastricht University and Orbis Medical Center Sittard
Type: | Journal: World journal of surgical oncology | Year: 2016
Seroma formation is a common complication following mastectomy for invasive breast cancer. Mastectomy flap fixation is achieved by reducing dead space volume using interrupted subcutaneous sutures.All patients undergoing mastectomy due to invasive breast cancer or ductal carcinoma in situ (DCIS) were eligible for inclusion. From May 2012 to March 2013, all patients undergoing mastectomy in two hospitals were treated using flap fixation. The skin flaps were sutured on to the pectoral muscle using polyfilament absorbable sutures. The data was retrospectively analysed and compared to a historical control group that was not treated using flap fixation (May 2011 to March 2012).One hundred and eighty patients were included: 92 in the flap fixation group (FF) and 88 in the historical control group (HC). A total of 33/92 (35.9%) patients developed seroma in the group that underwent flap fixation; 52/88 (59.1%) patients developed seroma in the HC group (p=0.002). Seroma aspiration was performed in 14/92 (15.2%) patients in the FF group as opposed to 38/88 (43.2%) patients in the HC group (p<0.001).Flap fixation is an effective surgical technique in reducing dead space and therefore seroma formation and seroma aspirations in patients undergoing mastectomy for invasive breast cancer or DCIS.
PubMed | Atrium Medical, Maastricht University and Orbis Medical Center Sittard
Type: Journal Article | Journal: Gastrointestinal endoscopy | Year: 2015
Several studies examined the rate of colorectal cancer (CRC) developed during colonoscopy surveillance after CRC resection (ie, metachronous CRC [mCRC]), yet the underlying etiology is unclear.To examine the rate and likely etiology of mCRCs.Population-based, multicenter study. Review of clinical and histopathologic records, including data of thenational pathology database and The Netherlands Cancer Registry.National cancer databases reviewed at 3 hospitals in South-Limburg, The Netherlands.Total CRC population diagnosed in South-Limburg from January 2001 to December2010.Colonoscopy.We defined an mCRC as a second primary CRC, diagnosed>6 months afterthe primary CRC. By using a modified algorithm to ascribe likely etiology, we classified the mCRCs into cancers caused by non-compliance with surveillance recommendations, inadequate examination, incomplete resection of precursor lesions (CRC in same segment as previous advanced adenoma), missed lesions, or newly developed cancers.We included a total of 5157 patients with CRC, of whom 93 (1.8%) had mCRCs, which were diagnosed onan average of 81 months (range 7-356 months) after the initial CRC diagnosis. Of all mCRCs, 43.0% were attributable to non-compliance with surveillance advice, 43.0% to missed lesions, 5.4% to incompletely resected lesions, 5.4% to newly developed cancers, and 3.2% to inadequate examination. Age-adjusted and sex-adjusted logistic regression analyses showed that mCRCs were significantly smaller in size (odds ratio [OR] 0.8; 95% confidence interval [CI], 0.7-0.9) and more often poorly differentiated (OR 1.7; 95% CI, 1.0-2.8) than were solitary CRCs.Retrospective evaluation of clinical data.In this study, 1.8% of all patients with CRC developed mCRCs, and the vast majority were attributable to missed lesions or non-compliance with surveillance advice. Our findings underscore the importance of high-quality colonoscopy to maximize the benefit of post-CRC surveillance.
Veldhorst-Janssen N.M.L.,Maastricht University |
Fiddelers A.A.A.,Maastricht University |
van der Kuy P.H.M.,Orbis Medical Center Sittard |
Theunissen H.M.S.,Maastricht University |
And 4 more authors.
Clinical Therapeutics | Year: 2011
Background: Intranasal (IN) midazolam is a potential alternative to rectal diazepam for the acute treatment of epileptic seizures. Objective: The purpose of this pilot study was to investigate the pharmacokinetics and tolerability of IN midazolam (50 mg/mL) compared with intravenous (IV) midazolam (2.5 mg) in healthy adult volunteers. Methods: In this single-dose, randomized-sequence, open-label, 2-period crossover pilot study subjects were randomly assigned to receive IN or IV midazolam, with a washout period of at least 5 days between treatments. The 50-mg/mL IN midazolam formulation consisted of 5 mg midazolam base per 0.1 mL (1 spray) and was administered once in 1 nostril. The IV midazolam solution (2.5 mg) was infused over 10 seconds. Blood samples were taken before and at regular intervals up to 240 minutes after dosing. Pharmacokinetic data (ie, C max, T max, t 1/2, and AUC) were analyzed using a 2-compartment model. Results: Of 9 volunteers screened and enrolled, 7 completed the study (mean age 34.1 [9.0] years; mean weight, 68.6 [10.4] kg, range 53-89 kg; 6 men, 3 women; all white). The mean C max of 78 (40) ng/mL was reached 44 minutes after IN administration, whereas the mean C max was 51 (5) ng/mL after IV administration. The mean estimated C t=5 min was 31.4 (28.1) ng/mL after IN administration. The elimination t 1/2 was 1.9 (0.41) hours for IN midazolam and 2.3 (0.19) hours for IV midazolam. The bioavailability of IN midazolam was 82%. There were few adverse events, with a local burning feeling in the nose being the most reported event (6 of 7 subjects). Conclusions: In this select group of healthy volunteers, concentrations of midazolam >30 ng/mL were reached within 5 minutes of IN administration at a dose of 5 mg/0.1 mL. A burning feeling in the nostril was the main adverse effect. Additional research is needed to evaluate the safety profile, convenience, satisfaction, and efficacy of nasal midazolam in the treatment of adults with seizures. This trial is registered at www.isrctn.org, No. ISRCTN79059168. © 2011 Elsevier HS Journals, Inc.