Mourits M.J.E.,University of Groningen |
Bijen C.B.,University of Groningen |
Arts H.J.,University of Groningen |
van der Sijde R.,Hospital Group Twente Hengelo |
And 6 more authors.
The Lancet Oncology | Year: 2010
Background: The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer. Methods: This randomised trial was done in 21 hospitals in the Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry, number NTR821. Findings: The proportion of major complications was 14·6% (27 of 185) in the TLH group versus 14·9% (14 of 94) in the TAH group, with a difference of -0·3% (95% CI -9·1 to 8·5; p=0·95). The proportion of patients with an intraoperative major complication (nine of 279 [3·2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11·5%]) and did not differ between TLH (five of 185 [2·7%]) and TAH (four of 94 [4·3%]; p=0·49). The proportion of patients with a minor complication was 13·0% (24 of 185) in the TLH group and 11·7% (11 of 94) in the TAH group (p=0·76). Conversion to laparotomy occurred in 10·8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p<0·0001), less use of pain medication (p<0·0001), a shorter hospital stay (p<0·0001), and a faster recovery (p=0·002), but the procedure took longer than TAH (p<0·0001). Interpretation: Our results showed no evidence of a benefit for TLH over TAH in terms of major complications, but TLH (done by skilled surgeons) was beneficial in terms of a shorter hospital stay, less pain, and quicker resumption of daily activities. Funding: The Dutch Organization for Health Research and Development (ZonMw), programme efficacy. © 2010 Elsevier Ltd.
Determination of dabigatran, rivaroxaban and apixaban by ultra-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants
Schmitz E.M.H.,Catharina Hospital |
Schmitz E.M.H.,TU Eindhoven |
Schmitz E.M.H.,Expert Center Clinical Chemistry Eindhoven |
Boonen K.,Catharina Hospital |
And 11 more authors.
Journal of Thrombosis and Haemostasis | Year: 2014
Background: Three novel direct oral anticoagulants (DOACs) have recently been registered by the Food and Drug Administration and European Medicines Agency Commission: dabigatran, rivaroxaban, and apixaban. To quantify DOACs in plasma, various dedicated coagulation assays have been developed. Objective: To develop and validate a reference ultra-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) method and to evaluate the analytical performance of several coagulation assays for quantification of dabigatran, rivaroxaban, and apixaban. Methods: The developed UPLC-MS/MS method was validated by determination of precision, accuracy, specificity, matrix effects, lower limits of detection, carry-over, recovery, stability, and robustness. The following coagulation assays were evaluated for accuracy and precision: laboratory-developed (LD) diluted thrombin time (dTT), Hemoclot dTT, Pefakit PiCT, ECA, Liquid anti-Xa, Biophen Heparin (LRT), and Biophen DiXal anti-Xa. Agreement between the various coagulation assays and UPLC-MS/MS was determined with random samples from patients using dabigatran or rivaroxaban. Results: The UPLC-MS/MS method was shown to be accurate, precise, sensitive, stable, and robust. The dabigatran coagulation assay showing the best precision, accuracy and agreement with the UPLC-MS/MS method was the LD dTT test. For rivaroxaban, the anti-factor Xa assays were superior to the PiCT-Xa assay with regard to precision, accuracy, and agreement with the reference method. For apixaban, the Liquid anti-Xa assay was superior to the PiCT-Xa assay. Conclusions: Statistically significant differences were observed between the various coagulation assays as compared with the UPLC-MS/MS reference method. It is currently unknown whether these differences are clinically relevant. When DOACs are quantified with coagulation assays, comparison with a reference method as part of proficiency testing is therefore pivotal. © 2014 International Society on Thrombosis and Haemostasis.
Niemarkt H.J.,Maxima Medical Center Veldhoven |
Niemarkt H.J.,Maastricht University |
De Meij T.G.,VU University Amsterdam |
Van De Velde M.E.,VU University Amsterdam |
And 7 more authors.
Inflammatory Bowel Diseases | Year: 2015
Necrotizing enterocolitis (NEC) remains one of the most frequent gastrointestinal diseases in the neonatal intensive care unit, with a continuing unacceptable high mortality and morbidity rates. Up to 20% to 40% of infants with NEC will need surgical intervention at some point. Although the exact pathophysiology is not yet elucidated, prematurity, use of formula feeding, and an altered intestinal microbiota are supposed to induce an inflammatory response of the immature intestine. The clinical picture of NEC has been well described. However, an early diagnosis and differentiation against sepsis is challenging. Besides, it is difficult to timely identify NEC cases that will deteriorate and need surgical intervention. This may interfere with the most optimal treatment of infants with NEC. In this review, we discuss the pathogenesis, diagnosis, and treatment of NEC with a focus on the role of microbiota in the development of NEC. An overview of different clinical prediction models and biomarkers is given. Some of these are promising tools for accurate diagnosis of NEC and selection of appropriate therapy. Copyright © 2014 Crohn's & Colitis Foundation of America, Inc.
Vaes R.H.D.,Maxima Medical Center Veldhoven |
Tordoir J.H.,Maastricht University |
Scheltinga M.R.,Maxima Medical Center Veldhoven
Journal of Vascular Surgery | Year: 2013
Objective: Hand ischemia may occur in the presence of a hemodialysis arteriovenous fistula (AVF), but its pathophysiology is partly unclear. The aim of this observational study was to investigate flow characteristics of forearm arteries in patients with a brachial artery-based AVF suffering from hemodialysis access-induced distal ischemia (HAIDI). Methods: A questionnaire scored hand ischemia in patients with HAIDI scheduled for revisional surgery (no symptoms of ischemia, 0 points; maximal ischemia, 500 points). Systolic index finger pressures (Pdig) and digital brachial index (DBI) were determined with open and compressed AVF. Blood flow direction and peak systolic velocity (PSV) were measured in radial and ulnar arteries using Doppler ultrasonography. Age- and sex-matched hemodialysis patients without HAIDI served as controls (CONT). Results: Questionnaire scores were 258 ± 30 in patients with HAIDI (n = 10) compared with 31 ± 16 in CONT (n = 10; P <.01). Pdig and DBI with open AVF were lower in the HAIDI group than the CONT group (Pdig 22 ± 10 vs 102 ± 10 mm Hg; DBI 0.18 ± 0.08 vs 0.70 ± 0.04; both P <.01). Ulnar artery PSV was lower in HAIDI compared with CONT patients (38 ± 4 vs 56 ± 3 cm/s; P <.01). Mean ulnar artery PSV was significantly correlated to P dig (r = 0.87; P <.01) in contrast to mean radial artery PSV (r = 0.06; P =.81). Ulnar artery blood flow direction was always toward the ischemic hand (n = 20). However, blood flow was reversed in just a short segment of the proximal radial artery in one HAIDI patient but also in two CONT patients. Conclusions: Hand ischemia in hemodialysis patients with a brachial artery-based AVF is not caused by a reversed blood flow direction in forearm arteries. However, forearm blood flow is diminished in these patients leading to critically reduced arterial pressures in the hand. © 2013 by the Society for Vascular Surgery.
Buffart L.M.,VU University Amsterdam |
Thong M.S.Y.,University of Tilburg |
Thong M.S.Y.,Comprehensive Cancer Center South |
Schep G.,Maxima Medical Center Veldhoven |
And 4 more authors.
PLoS ONE | Year: 2012
Background: Physical activity (PA) is suggested to be an important non-pharmacologic means to improve health-related outcomes among cancer survivors. We aimed to describe the PA level, its correlates, and association with health-related quality of life (HRQoL) in colorectal cancer (CRC) survivors. Methods: CRC survivors identified from the Eindhoven Cancer Registry treated between 1998 and 2007 were included. Survivors completed validated questionnaires on PA, distress, fatigue, and HRQoL. Moderate-to-vigorous physical activity (MVPA) levels were calculated by summing the time spent on walking, bicycling, gardening and sports (≥3 MET). Multiple linear regression analyses were conducted to study which socio-demographic and clinical factors were associated with MVPA. Furthermore, we examined associations between MVPA and physical and mental HRQoL, and whether these associations were mediated by fatigue and distress. Results: Cross-sectional data of 1371 survivors (response: 82%) were analysed. Participants were 69.5 (SD 9.7) years old, 56% were male, and survival duration was 3.9 (SD 2.5) years. Participants self-reported on average 95.5 (SD 80.3) min on MVPA per day. Younger age, male sex, being employed, non-smoking, lower BMI, colon cancer (vs. rectal cancer), chemotherapy treatment and having no co-morbidities were associated with higher MVPA (p<0.05). MVPA was positively associated with physical HRQoL (regression coefficient of total association (c) = 0.030; se = 0.004) after adjusting for socio-demographic and clinical factors. Fatigue mediated this association between MVPA and physical HRQoL (44% mediated). The association between MVPA and mental HRQoL was not statistically significant after adjusting for socio-demographic and cancer-related factors (c = 0.005; se = 0.004). Conclusion: In CRC survivors, clinical factors including the absence of co-morbidity, tumour site and chemotherapy treatment were associated with higher MVPA, in addition to several socio-demographic factors. Higher MVPA was associated with higher physical HRQoL but not with mental HRQoL. Fatigue and distress mediated the association between MVPA and HRQoL. © 2012 Buffart et al.
Van Pul C.,University Utrecht |
Van Pul C.,Maxima Medical Center Veldhoven |
Van Pul C.,TU Eindhoven |
Van Kooij B.J.M.,University Utrecht |
And 4 more authors.
American Journal of Neuroradiology | Year: 2012
BACKGROUND AND PURPOSE: Signal-intensity abnormalities in the PLIC and thinning of the CC are often seen in preterm infants and associated with poor outcome. DTI is able to detect subtle abnormalities. We used FT to select bundles of interest (CC and PLIC) to acquire additional information on the WMI. MATERIALS AND METHODS: One hundred twenty preterm infants born at <31 weeks' gestation with 3T DTI at TEA entered this prospective study. Quantitative information (ie, volume, length, anisotropy, and MD) was obtained from fiber bundles passing through the PLIC and CC. A general linear model was used to assess the effects of factor (sex) and variables (GA, BW, HC, PMA, and WMI) on FT-segmented parameters. RESULTS: Seventy-two CC and 85 PLIC fiber bundles were assessed. For the CC, increasing WMI and decreasing FA (P = .038), bundle volume (P < .001), and length (P = .001) were observed, whereas MD increased (P = .001). For PLIC, MD increased with increasing WMI (P = .002). Higher anisotropy and larger bundle length were observed in the left PLIC compared with the right (P = .003, P = .018). CONCLUSIONS: We have shown that in the CC bundle, anisotropy was decreased and diffusivity was increased in infants with high WMI scores. A relation of PLIC with WMI was also shown but was less pronounced. Brain maturation is affected more if birth was more premature.
Van Hoek F.,Maxima Medical Center Veldhoven |
Scheltinga M.R.,Maxima Medical Center Veldhoven |
Houterman S.,MMC Academy |
Beerenhout C.H.,Maxima Medical Center
Nephrology | Year: 2010
Background: During haemodialysis, some patients experience intensification of symptoms of haemodialysis access-induced distal ischaemia. Aim of this study is to compare the effects of two different regimens of arterial blood flow in patients with an arteriovenous access. Methods: A questionnaire identified 10 patients that subjectively experienced ischaemic symptoms during haemodialysis. Systolic blood pressure, heart rate, finger pressure (Pdig), finger temperature (Tdig), oxygen saturation and ischaemic scores were monitored during two different arterial blood flow dialysis sessions. Results: Before dialysis, Pdig and Tdig of the arteriovenous access hand were significantly lower compared with the other hand. Haemodialysis induced a drop of Pdig in both hands. All changes in Pdig occurred independent of the artificial kidney's blood flow level. Conclusion: Systemic hypotension following onset of haemodialysis further intensifies an already diminished hand perfusion. Measures preventing dialytic hypotension will likely attenuate symptoms associated with haemodialysis access-induced distal ischaemia during haemodialysis. © 2010 The Authors.
Nieboer T.E.,Radboud University Nijmegen |
Nieboer T.E.,Maxima Medical Center Veldhoven |
Hendriks J.C.M.,Radboud University Nijmegen |
Hendriks J.C.M.,Maxima Medical Center Veldhoven |
And 6 more authors.
Obstetrics and Gynecology | Year: 2012
OBJECTIVE: To report the 4-year follow-up quality-of-life data of a randomized controlled trial between abdominal and laparoscopic hysterectomy and to investigate whether any difference in quality of life would remain long-term. METHODS: Patients scheduled for hysterectomy for benign indications were randomized and received the Dutch version of the Short Form 36 questionnaire. The Short Form 36 consists of eight domains in which 100 points can be obtained. Higher scores denote a higher quality of life. A linear mixed model was used to study the differences between the two groups up to 4 years after surgery for each of the domains and the total Short Form 36 score separately. RESULTS: Fifty-nine patients were randomized (27 to laparoscopic hysterectomy and 32 to abdominal hysterectomy). Median follow-up after surgery was 243 weeks (range, 188-303 weeks). The overall response rate on the Short Form 36 questionnaire after 4 years was 83% (49 of 59 patients). Total Short Form 36 questionnaire scores were significantly higher in patients after laparoscopic compared with abdominal hysterectomy up to 4 years after surgery (overall mean difference 50.4 points [95% confidence interval 1.0-99.7] in favor of laparoscopic hysterectomy). Higher scores were also found on the domains physical role functioning, social role functioning, and vitality. CONCLUSION: With a follow-up of 4 years, patients who underwent laparoscopic hysterectomy reported a better quality of life compared with abdominal hysterectomy. Therefore, patients in whom vaginal hysterectomy is not possible should be able to have a laparoscopic hysterectomy, if feasible, in terms of uterine size. © 2012 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams &Wilkins.
Truijens S.E.M.,Maxima Medical Center Veldhoven |
Pommer A.M.,University of Tilburg |
Van Runnard Heimel P.J.,Maxima Medical Center Veldhoven |
Verhoeven C.J.M.,Maxima Medical Center Veldhoven |
And 2 more authors.
European Journal of Obstetrics Gynecology and Reproductive Biology | Year: 2014
Objective To develop an instrument to the assess quality of care during pregnancy and delivery as perceived by women who recently gave birth. Study design Prospective design from focus group interviews to validation of the questionnaire. The focus groups consisted of seven care providers, ten pregnant women and six women who recently gave birth. With the results of the focus group interviews, a draft questionnaire of 52 items was composed and its psychometric properties were tested in a first cohort of 300 women who recently gave birth (sample I) by means of exploratory factor analysis (EFA) and reliability analysis. The final version was further explored by confirmatory factor analyses (CFA) in another sample of 289 women (sample II) with similar characteristics as sample I. Results EFA in sample I suggested an 18-item scale with two components concerning the quality of care during pregnancy: 'personal treatment' (11 items, Cronbach's alpha (α) = 0.87) and 'educational information' (7 items, α = 0.90); the 'delivery' scale showed a single domain (7 items, α = 0.88). CFA in sample II confirmed both factor structures with an adequate model fit. Overall, satisfaction with care was highest among women who only received midwife-led care, while women who were referred to an obstetrician during pregnancy reported less satisfaction. Conclusions The 25-item PCQ, primarily based on the experiences and perceptions of pregnant women and women who recently gave birth, showed adequate psychometric properties evaluating the quality of care during pregnancy and delivery. This user-friendly instrument might be a valuable instrument for future research to further evaluate the quality of care to pregnant women. © 2013 Elsevier Ireland Ltd.
Scheltinga M.R.,Maxima Medical Center Veldhoven |
Bruijninckx C.M.A.,Maxima Medical Center Veldhoven
European Journal of Vascular and Endovascular Surgery | Year: 2012
Objectives: Some haemodialysis patients with an arteriovenous fistula (AVF) suffer from chronic hand ischaemia (haemodialysis access-induced distal ischaemia, HAIDI). This overview discusses pathophysiological mechanisms of chronic HAIDI with emphasis on the role of steal and loco-regional hypotension. Materials and methods: The literature obtained from Medline and Google using various terms including steal and hand ischaemia was studied for clues on pathophysiology of hand ischaemia in the presence of an AVF. Results: Constructing an arteriovenous anastomosis as in a haemodialysis access leads to augmented blood flows in arm arteries. Due to increased shear stress, these arteries will remodel while hand perfusion pressures are maintained. However, arteries of some dialysis patients with diabetes mellitus and/or severe arteriosclerosis demonstrate insufficient remodelling leading to a gradual loss of perfusion pressures towards the periphery. A blood pressure drop associated with turbulent flow at the arteriovenous anastomosis intensifies the distal hypotension. By contrast, steal (reversal of blood flow) may reflect an upstream arterial stenosis and patent collaterals but its presence has no pathophysiological significance related to hand ischaemia. Conclusion: HAIDI is caused by too low forearm and hand blood pressures. Therapy should focus on attenuating the loss of arterial pressure including optimalisation of inflow arteries and/or ligation of the AVF's venous side branches. Surgery aimed at access flow reduction or distal revascularisation is only indicated if these measures fail. © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.