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Vitamin D is an important factor in bone metabolism. Animal studies have shown a positive effect of vitamin D-3 supplementation on fracture healing, but evidence from clinical trials is inconclusive. A randomized controlled trial was performed to assess the effects of vitamin D-3 supplementation on fracture healing using HR-pQCT-based outcome parameters. Thirty-two postmenopausal women with a conservatively treated distal radius fracture were included within 2 weeks postfracture and randomized to a low-dose (N = 10) and a high-dose (N = 11) vitamin D intervention group receiving a 6-week bolus dose, equivalent to 700 and 1800 IU vitamin D-3 supplementation per day, respectively, in addition to a control group (N = 11) receiving no supplementation. After the baseline visit 1-2 weeks postfracture, follow-up visits were scheduled at 3-4, 6-8, and 12 weeks postfracture. At each visit, HR-pQCT scans of the fractured radius were performed. Cortical and trabecular bone density and microarchitectural parameters and microfinite element analysis-derived torsion, compression, and bending stiffness were assessed. Additionally, serum markers of bone resorption (CTX) and bone formation (PINP) were measured. Baseline serum levels of 25OHD(3) were

Patients and breast cancer surgeons are frequently confronted with wound complications after mastectomy. Negative pressure wound therapy (NPWT) is a promising technique for preventing wound complications after skin closure in elective surgery. However, a clinical study evaluating postoperative complications following the use of NPWT, focusing solely on closed incisions in patients undergoing mastectomy, has yet to be performed. Between June 2019 and February 2020, 50 consecutive patients underwent mastectomy with NPWT during the first seven postoperative days. This group was compared to a cohort of patients taking part in a randomized controlled trial between June 2014 and July 2018. Primary outcome was the rate of postoperative wound complications, i.e. surgical site infections, wound necrosis or wound dehiscence during the first three postoperative months. Secondary outcomes were the number of patients requiring unplanned visits to the hospital and developing clinically significant seroma (CSS). In total, 161 patients were analyzed, of whom 111 patients in the control group (CON) and 50 patients in the NPWT group (NPWT). Twenty-eight percent of the patients in the NPWT group developed postoperative wound complications, compared to 18.9% in the control group (OR = 1.67 (95% CI 0.77–3.63), p = 0.199). The number of patients requiring unplanned visits or developing CSS was not statistically significant between the groups. This study suggests that Avelle negative pressure wound therapy in mastectomy wounds does not lead to fewer postoperative wound complications. Additionally, it does not lead to fewer patients requiring unplanned visits or fewer patients developing clinically significant seromas.Trial registration: ClinicalTrials.gov number, NCT03942575. Date of registration: 08/05/2019.

Background: Seroma is a common complication after mastectomy. The aim of this review is to elucidate whether closed suction drainage can safely be omitted in patients undergoing mastectomy when assessing seroma formation and its complications. The second aim is to assess the influence of flap fixation on seroma related complications, as there is existing evidence showing that combining mastectomy with flap fixation may make the use of drainage systems obsolete. Search & selection: A review of the literature was performed and articles that compared mastectomy with drainage and mastectomy without drainage were selected. Due to the small number of eligible studies, no selection based on whether flap fixation was performed was possible. If outcome was described in terms of seroma formation or seroma related complications, papers were eligible for inclusion. Studies older than 20 years, animal studies, studies not written in English and studies with male patients were excluded. Results: A total of eight articles were eligible for inclusion. Four prospective studies and four retrospective studies were included. In four studies, flap fixation was performed. Frequency of seroma formation as well as seroma that required intervention was reported. The included studies demonstrated that omitting closed suction drainage does not lead to a higher incidence of seroma formation in patients undergoing mastectomy. Conclusion: Despite substantial heterogeneity, there is evidence that drainage can safely be omitted without exacerbating seroma formation and its complications. A well-powered, randomized controlled trial evaluating the effect of drainage omission on seroma formation, with or without flap fixation, is needed. (C) 2020 Elsevier Ltd, BASO similar to The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Background Around 20% of patients undergoing spinal fusion surgery have persistent back or leg pain despite surgery. Pain catastrophizing is the strongest psychological predictor for chronic postsurgical pain. Psychological variables are modifiable and could be target for intervention. However, randomized controlled trials evaluating the effectiveness of psychological interventions to reduce chronic pain and disability after spinal fusion in a population of patients with high preoperative pain catastrophizing scores are missing. The aim of our study is to examine whether an intervention targeting pain catastrophizing mitigates the risk of chronic postsurgical pain and disability. Our primary hypothesis is that targeted perioperative cognitive behavioral therapy decreases the risk of chronic postsurgical pain and disability after spinal fusion surgery in high catastrophizing patients. Methods We will perform a two-center prospective, single-blind, randomized, controlled study comparing lumbar spinal fusion surgery outcome between 2 cohorts. Adult patients selected for lumbar spinal fusion with decompression surgery and a minimum score of 24 on the pain catastrophizing scale will be randomized with 1:1 allocation for either perioperative cognitive behavioral therapy (intervention group) or a perioperative education plus progressive exercise program (control group). Patients randomized to the intervention group will receive six individual sessions of cognitive behavioral therapy, two sessions before the operation and four after. Primary outcome is the Core Outcome Measures Index at 12 months. Secondary outcomes include pain, disability, depression and quality of life. Discussion This is the first trial that evaluates the effectiveness of cognitive behavioral therapy as a perioperative tool to improve pain and disability after spinal fusion surgery in comparison with an educational/exercise control intervention, in patients with high levels of pain catastrophizing. If perioperative cognitive behavioral therapy proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcome after spinal fusion surgery. Trial registration Clinicaltrials (NCT03969602). Registered 31 May 2019

Improving the clinical outcome of scaphoid fractures may benefit from adequate monitoring of their healing in order to for example identify complications such as scaphoid nonunion at an early stage and to adjust the treatment strategy accordingly. However, quantitative assessment of the healing process is limited with current imaging modalities. In this study, high-resolution peripheral quantitative computed tomography (HR-pQCT) was used for the first time to assess the changes in bone density, microarchitecture, and strength during the healing of conservatively-treated scaphoid fractures. Thirteen patients with a scaphoid fracture (all confirmed on HR-pQCT and eleven on CT) received an HR-pQCT scan at baseline and three, six, twelve, and 26 weeks after first presentation at the emergency department. Bone mineral density (BMD) and trabecular microarchitecture of the scaphoid bone were quantified, and failure load (FL) was estimated using micro-finite element analysis. Longitudinal changes were evaluated with linear mixed-effects models. Data of two patients were excluded due to surgical intervention after the twelve-week follow-up visit. In the eleven fully evaluable patients, the fracture line became more apparent at 3 weeks. At 6 weeks, individual trabeculae at the fracture region became more difficult to identify and distinguish from neighboring trabeculae, and this phenomenon concerned a larger region around the fracture line at 12 weeks. Quantitative assessment showed that BMD and FL were significantly lower than baseline at all follow-up visits with the largest change from baseline at 6 weeks (-13.6% and -23.7%, respectively). BMD remained unchanged thereafter, while FL increased. Trabecular thickness decreased significantly from baseline at three (-3.9%), six (-6.7%), and twelve (-4.4%) weeks and trabecular number at six (-4.5%), twelve (-7.3%), and 26 (-7.9%) weeks. Trabecular separation was significantly higher than baseline at six (+13.3%), twelve (+19.7%), and 26 (+16.3%) weeks. To conclude, this explorative HR-pQCT study showed a substantial decrease in scaphoid BMD, Tb.Th, and FL during the first 6 weeks of healing of conservatively-treated scaphoid fractures, followed by stabilization or increase in these parameters. At 26 weeks, BMD, trabecular microarchitecture, and FL were not returned to baseline values. research foundation of VieCuri Medical Center Noord-Limburg, The Netherlands [NL62476.068.17]

Background. Residual axillary lymph node involvement after neoadjuvant systemic therapy (NST) is the determining factor for postmastectomy radiation therapy (PMRT). Preoperative identification of patients needing PMRT is essential to enable shared decision-making when choosing the optimal timing of breast reconstruction. We determined the risk of positive sentinel lymph node (SLN) after NST in clinically node-negative (cN0) breast cancer.Methods. All cT1-3N0 patients treated with NST followed by mastectomy and SLNB between 2010 and 2016 were identified from the Netherlands Cancer Registry. Rate of positive SLN for different breast cancer subtypes was determined. Logistic regression analysis was performed to determine correlated clinicopathological variables with positive SLN.Results. In total 788 patients were included, of whom 25.0% (197/788) had positive SLN. cT1-3N0 ER+HER2+, cT1-3N0 ER-HER2+, and cT1-2N0 triple-negative patients had the lowest rate of positive SLN: 7.2-11.5%, 0-6.3%, and 2.9-6.2%, respectively. cT1-3N0 ER+HER2- and cT3N0 triple-negative patients had the highest rate of positive SLN: 23.8-41.7% and 30.4%, respectively. Multivariable regression analysis showed that cT2 (odds ratio [OR] 1.93; 95% confidence interval [CI] 1.01-3.96), cT3 (OR 2.56; 95% CI 1.30-5.38), grade 3 (OR 0.44; 95% CI 0.21-0.91), and ER+HER2- subtype (OR 3.94; 95% CI 1.77-8.74) were correlated with positive SLN.Conclusions. In cT1-3N0 ER+HER2+, cT1-3N0 ER-HER2+, and cT1-2N0 triple-negative patients treated with NST, immediate reconstruction can be considered an acceptable option due to low risk of positive SLN. In cT1-3N0 ER+HER2- and cT3N0 triple-negative patients treated with NST, risks and benefits of immediate reconstruction should be discussed with patients due to the relatively high risk of positive SLN.

This study explored the course of health state utility value over 3 years in patients with a recent fracture attending a Fracture Liaison Service and suggested that the overall change in health-related quality of life was not significant, although significant improvements were observed at 6 and 12 months compared to baseline.To estimate the 3-year health-related quality of life (HRQoL) of patients with a recent fracture presenting at a Fracture Liaison Service (FLS) and to explore factors associated with health state utility value (HSUV).Patients' HSUVs were derived from the EQ-5D-5L and SF-6D and calculated at six time points. Multiple imputation was applied for missing data. Linear mixed-effects regression analysis with random intercept and slope was applied to explore the course of HSUV over 3 years. The impact of subsequent fracture and the length of time between FLS visit and patients' index fracture on HSUV were also investigated. A backward stepwise elimination was applied to identify factors associated with HSUV.A total of 499 patients were included. The change of EQ-5D HSUV was not significant over 3-year follow-up (P = 0.52), although slightly but significantly higher HSUV was captured at 6 months (mean difference (MD): 0.015, P = 0.02) and 12 months (MD: 0.018, P = 0.01). There was no significant difference in the course of EQ-5D HSUV between fracture locations (P = 0.86). A significant increase in HSUV was only captured for patients had shorter time period ( 107 days) between FLS visit and their index fracture. Suffering a subsequent fracture was associated with significant QoL loss (MD: - 0.078, P 0.001). Subsequent fracture, previous treatment with anti-osteoporosis medication, a prevalent vertebral fracture (grade 2 or 3), use of a walking aid, previous falls, and higher BMI were negatively associated with mean EQ-5D HSUV over 3 years. Comparable results were found using SF-6D HSUV. The lack of HRQoL data immediately after fracture and selection bias were two main limitations.The 3-year change in HSUV was not statistically significant, although significant improvements were observed at 6 and 12 months in comparison with baseline. Six factors were negatively associated with EQ-5D HSUV.

Purpose It has been hypothesized that autologous breast reconstruction can cause reactivation of dormant micro metastases by its extensive tissue trauma, influencing the risk of breast cancer recurrence. However, about the specific effect of timing on breast cancer recurrence in the deep inferior epigastric perforator (DIEP) flap reconstruction is not much known. In this study the rate of local, regional and distant recurrence between patients undergoing an immediate and delayed autologous DIEP flap breast reconstruction were evaluated. Methods In this retrospective cohort study, breast cancer patients undergoing a DIEP flap breast reconstruction between 2010 and 2018 in three hospitals in the Netherlands were evaluated. Cox proportional hazards regression analyses were performed to assess the impact of different factors on breast cancer recurrence. The primary endpoint was local breast cancer recurrence. Secondary endpoints were regional and distant recurrence. Results A total of 919 DIEP-flap reconstructions were done in 862 women of which 347 were immediate- and 572 were delayed DIEP flap reconstructions. After a median follow-up of 46 months and 86 months respectively (p p = 0.001, 95% CI 1.536, 5437). Conclusion This study suggests an increased risk for breast cancer recurrence in women receiving a delayed DIEP flap reconstruction as compared to women receiving an immediate DIEP flap reconstruction. However, these data should be interpreted carefully as a result of selection bias.

Background Current risk models for renal cell carcinoma (RCC) based on clinicopathological factors are sub-optimal in accurately identifying high-risk patients. Here, we perform a head-to-head comparison of previously published DNA methylation markers and propose a potential prognostic model for clear cell RCC (ccRCC). Patients and methods Promoter methylation of PCDH8, BNC1, SCUBE3, GREM1, LAD1, NEFH, RASSF1A, GATA5, SFRP1, CDO1, and NEURL was determined by nested methylation-specific PCR. To identify clinically relevant methylated regions, The Cancer Genome Atlas (TCGA) was used to guide primer design. Formalin-fixed paraffin-embedded (FFPE) tissue samples from 336 non-metastatic ccRCC patients from the prospective Netherlands Cohort Study (NLCS) were used to develop a Cox proportional hazards model using stepwise backward elimination and bootstrapping to correct for optimism. For validation purposes, FFPE ccRCC tissue of 64 patients from the University Hospitals Leuven and a series of 232 cases from The Cancer Genome Atlas (TCGA) were used. Results Methylation of GREM1, GATA5, LAD1, NEFH, NEURL, and SFRP1 was associated with poor ccRCC-specific survival, independent of age, sex, tumor size, TNM stage or tumor grade. Moreover, the association between GREM1, NEFH, and NEURL methylation and outcome was shown to be dependent on the genomic region. A prognostic biomarker model containing GREM1, GATA5, LAD1, NEFH and NEURL methylation in combination with clinicopathological characteristics, performed better compared to the model with clinicopathological characteristics only (clinical model), in both the NLCS and the validation population with a c-statistic of 0.71 versus 0.65 and a c-statistic of 0.95 versus 0.86 consecutively. However, the biomarker model had limited added prognostic value in the TCGA series with a c-statistic of 0.76 versus 0.75 for the clinical model. Conclusion In this study we performed a head-to-head comparison of potential prognostic methylation markers for ccRCC using a novel approach to guide primers design which utilizes the optimal location for measuring DNA methylation. Using this approach, we identified five methylation markers that potentially show prognostic value in addition to currently known clinicopathological factors.

Preliminary results of metal-on-metal (MoM) hip arthroplasty were satisfactory, but since 2004 data showed high failure rates. National joint replacement registries are multi-centre databases comprised of thousands of subjects and implants which allow for identifying variables predictive of implant failure. The aim of the current study was to estimate re-revision rates after revision of a primary MoM hip arthroplasty in the Dutch Arthroplasty Register (LROI) and to assess potential predictor variables of re-revision of these MoM hip arthroplasties.Eligible procedures were those with a revision for any reason except infection, after an initial primary surgery with a hip resurfacing (HRA) or large-head MoM (LH-MoM) total hip arthroplasty (THA). The probability of re-revision for both types of MoM hip arthroplasty over time was estimated using the cumulative incidence function taking mortality as a competing risk into account. A proportional sub-distribution hazards regression model was used to assess potential predictor variables of re-revision of these MoM hip arthroplasties.A total of 3476 records of revised implants were included, of which 873 (25.2%) were MoM implants. Over the course of follow-up, 101 (11.5%) MoM implants were re-revised. During follow-up 36 (4.3%) patients who received a MoM-implant at primary arthroplasty and a revision afterwards had died. The regression model showed that for primary MoM implants a MoM articulation after revision (HR 2.48; 95% CI 1.53-4.03, p 0.001), femoral-only revisions (HR 3.20; 95% CI 2.06-4.99, p 0.001) and periprosthetic fractures (HR 1.98; 95% CI 1.03-3.82, p = 0.042) as reason for the first revision were statistically significant risk factors for re-revision.Both types of large-head MoM hip arthroplasties have shown high revision and re-revision rates; risk factors were identified. The outcome of this study can be helpful in managing expectations of patients and orthopaedic surgeons.

Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae.Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores.Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain.Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757).The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.

Purpose A systematic review, to study treatment effects for osteoporotic vertebral fractures (OVFs) in the elderly including all available evidence from controlled trials on percutaneous cement augmentation. Methods Primary studies, published up to December, 2019, were searched in PubMed and the Cochrane Library. Selected were all prospective controlled studies including patients > 65 years of age and reporting on at least one main outcome. Main outcomes were pain, disability and quality of life (QOL) 1 day post-intervention and at 6 months postoperatively. Excluded were meta-analyses or reviews, retrospective or non-controlled studies, case studies, patients’ groups with neoplastic and/or traumatic fractures and/or neurologically compromised patients. Results Eighteen studies comprising 2165 patients (n = 1117 percutaneous cement augmentation, n = 800 conservative treatment (CT), n = 248 placebo) with a mean follow-up of up to 12 months were included. Pooled results showed significant pain relief in favor of percutaneous cement augmentation compared to CT, direct postoperative and at 6 months follow-up. At 6 months, a significant difference was observed for functional disability scores in favor of percutaneous cement augmentation. When comparing percutaneous cement augmentation to placebo, no significant differences were observed. Conclusion This review incorporates all current available evidence (RCTs and non-RCTs) on the efficacy of percutaneous cement augmentation in the treatment of OVFs in the elderly. Despite methodological heterogeneity of the included studies, this review shows overall significant sustained pain relief and superior functional effect in the short- and long term for percutaneous cement augmentation compared to conservative treatment. Graphic abstract These slides can be retrieved under Electronic Supplementary Material.

Purpose The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. Methods This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF)

Contains fulltext : 182368.pdf (Publisher’s version ) (Closed access) OBJECTIVES: To establish reference values for flow-mediated dilatation (FMD) and brachial artery diameter (BAD) in pregnancy and to provide insight into the physiological and pathological course of endothelial adaptation throughout human singleton pregnancy. METHODS: A meta-analysis was performed following a systematic review of current literature on FMD, as a derivative for endothelial function, and BAD, throughout uncomplicated and complicated pregnancy. PubMed (NCBI) and EMBASE (Ovid) electronic databases were used for the literature search, which was performed from inception to 9 June 2016. To allow judgment of changes in comparison with the non-pregnant state, studies were required to report both non-pregnant mean reference of FMD (matched control group, prepregnancy or postpartum measurement) and mean FMD at a predetermined and reported gestational age. Pooled mean differences between the reference and pregnant FMD values were calculated for predefined intervals of gestational age. RESULTS: Fourteen studies that enrolled 1231 participants met the inclusion criteria. Publication dates ranged from 1999 to 2014. In uncomplicated pregnancy, FMD was increased in the second and third trimesters. Between 15 and 21 weeks of gestation, absolute FMD increased the most, by a mean (95% CI) of 1.89% (0.25-3.53%). This was a relative increase of 22.5% (3.0-42.0%) compared with the non-pregnant reference. BAD increased progressively, in a steady manner, by the second trimester but not significantly in the first half of the second trimester. We could not discern differences in FMD and BAD between complicated and uncomplicated pregnancies at 29-35 weeks' gestation, reported in the three studies that met our inclusion criteria. Despite the increase in FMD and BAD throughout gestation, both reference curves were characterized by wide 95% CIs. CONCLUSION: During healthy pregnancy, endothelium-dependent vasodilatation and BAD increase. Women with a complicated pregnancy had FMD values within the lower range when compared with those with uncomplicated pregnancy but, as a group, did not differ from each other. Copyright (c) 2017 ISUOG. Published by John Wiley & Sons Ltd.

Identifying determinants of long-term functional outcome after a distal radius fracture is challenging. Previously, we reported on the association between early HR-pQCT measurements and clinical outcome 12 weeks after a conservatively treated distal radius fracture. We extended the follow-up and assessed functional outcome after two years in relation to early HR-pQCT derived bone parameters.HR-pQCT scans of the fracture region were performed in 15 postmenopausal women with a distal radius fracture at 1-2 (baseline), 3-4 weeks and 26 months post-fracture. Additionally, the contralateral distal radius was scanned at baseline. Bone density, micro-architecture parameters and bone stiffness using micro-finite element analysis (FEA) were evaluated. During all visits, wrist pain and function were assessed using the patient-rated wrist evaluation questionnaire (PRWE), quantifying functional outcome with a score between 0 and 100.Two-year PRWE was associated with torsional and bending stiffness 3-4 weeks post-fracture (R-2: 0.49, p = 0.006 and R-2: 0.54, p = 0.003, respectively). In contrast, early micro-architecture parameters of the fracture region or contralateral bone parameters did not show any association with long-term outcome.This exploratory study indicates that HR-pQCT with mu FEA performed within four weeks after a distal radius fracture captures biomechanical fracture characteristics that are associated with long-term functional outcome and therefore could be a valuable early outcome measure in clinical trials and clinical practice.

Purpose The aim of the study is to evaluate the level of sensible impairment after mastectomy or implant-based breast reconstruction (IBBR). In addition, factors influencing breast sensibility were evaluated. Methods A cross-sectional study was performed in Maastricht University Medical Center between July 2016 and August 2018. Women with unilateral mastectomy with or without IBBR were included. Objective sensory measurements were performed using Semmes–Weinstein monofilaments. Their healthy breast served as control, using a paired t test. Differences between mastectomy with and without IBBR were evaluated using the independent t test. Linear regression was performed to evaluate the association between patient characteristics on breast sensibility. The paired t test was used to evaluate in which part of the breast the sensibility is best preserved. Results Fifty-one patients were eligible for inclusion. Sixteen patients underwent IBBR after mastectomy. Twenty-three patients received radiotherapy and 35 patients received chemotherapy. Monofilament values were significantly higher in the operated group compared to the reference group (p

Objective: To assess the capacity of transvaginal hydrolaparoscopy (THL) versus hysterosalpingography (HSG) as a primary tool to diagnose tubal pathology.Study Design: We performed a multicenter RCT (NTR3462) in 4 teaching hospitals in the Netherlands, comparing THL and HSG as first line tubal test in subfertile women. The primary outcome of the trial was cumulative live birth rate at 24 months. Here, we present the secondary outcomes, the diagnostic findings of both THL and HSG as well as performance defined as failures, complications and pain- and acceptability scores.Results: Between May 2013 and October 2016, we allocated 149 women to THL and 151 to HSG, of which 17 women in the THL group (11.4%) and 12 in the HSG group (7.9%) conceived naturally before the scheduled procedure, while 13 HSGs and 5 THLs were not performed for other reasons (withdrawal of informed consent, not willing to undergo tubal testing and protocol violations). A total of 119 THLs and 134 HSGs were carried out. Failures were seen more in the THL group (n = 8, 5.6%) than in the HSG group (n = 1, 0.7%) (p = 0.014). Complications did not differ significantly between the groups (THL n =4; 2.8% vs HSG n =1; 0.7%) (p = 0.20). Bilateral tubal occlusion was detected in one versus three women (0.9% versus 2.2%) of the THL group and HSG group, while unilateral tubal occlusion was detected in seven (6.2%) versus eight (5.9%) women, respectively. Normal findings were seen in 96 (79.3%) women randomised to THL and in 119 (87.5%) in women randomised for HSG (RR 0.91 95%CI 0.81-1.01, p = 0.08). The pain score was significantly less for THL (VAS 4.7 (SD: 2.5)) than for HSG (VAS 5.4 (SD:2.5)) (p 0.038). The acceptability rate of THL and was high and comparable.Conclusion: THL and HSG have a comparable capacity in diagnosing tubal pathology with comparable performance in safety, pain and acceptability. (C) 2019 Elsevier B.V. All rights reserved.

Background: Seroma formation is a common complication after mastectomy. Flap fixation has the potential to prevent seroma formation, but identifying patients that are at risk of developing seroma, remains challenging. The aim of this study was to assess the association between pro-inflammatory cytokines in seroma fluid one day after surgery and seroma formation and it sequelae.Methods: Patients undergoing mastectomy were randomized into one of three groups: no flap fixation, flap fixation using sutures or flap fixation using tissue glue. Seroma samples from 40 consecutive patients undergoing mastectomy were collected on the first postoperative day for analysis of interleukin-6 and tumor necrosis factor-alpha. Seroma formation and its sequelae were assessed in the outpatient clinic ten days, six weeks and three months after surgery.Results: TNF-alpha concentrations were not detectable in the seroma samples of any of the 40 patients. BMI (p = 0.001) and weight of the resected surgical specimen (p = 0.003) were associated with higher IL-6 levels in seroma on the first postoperative day after mastectomy. A higher seroma concentration of IL-6 was associated with significantly fewer patients with clinical seroma formation three months after surgery (p = 0.027).Conclusion: IL-6 is associated with clinical seroma formation three months after surgery. There is however no evident association between IL-6 and complications related to seroma formation. Higher IL-6 levels are predictive of less long-term seroma formation. Application of flap fixation does not seem to influence the level of IL-6.

Purpose: DW-MRI parameters such as ADC hold the potential for more reliable staging of cervical cancer. We compared 2D region of interest (ROI) measurement techniques to 3D tumor analysis in the evaluation of ADC for cervical cancer. Secondly, we evaluated the utility of ADC for assessing parametrial and/or lymph node involvement.Method: This prospective patient cohort registered cervical cancer patients who underwent pre-operative MRI with T1, T2W, and axial DWI. Retrospectively, two observers independently and blindly scored mean, minimum, and maximum ADC using three methods: a) 3D-Tumor analysis, b) single freehand ROI (2D-Slice), and c) single circular ROI (2D-Circle). Another observer scored parametrial and lymph node involvement on T1/T2W sequences. Parametrial and/or lymph node involvement were determined by surgical-pathologic results. The diagnostic performance of ADC for predicting the latter was evaluated by ROC curve, uni and multivariate analyses.Results: Of 58 included patients, parametrial and/or lymph node involvement was found in 9 and 11 patients, respectively. Mean ADC (ADC(Mean)) was least dependent on ROI technique, with interobserver variability (ICC: 0.88-0.90) and linear correlation (Pearson's r: 0.95-0.96). To the contrary, minimal and maximal ADC were significantly influenced by 2D-ROI techniques. ADC(mean) was shown to be an independent predictor of parametrial (AUC: 0.80-0.86; OR: 16, 1.4-178) and/or lymph node involvement (AUC: 0.74-0.79; OR: 5.1, 1.1-24).Conclusions: Single ROI measurements are a reliable method for determining ADC(Mean) in cervical cancer. Second, ADC(Mean) serves as a potential parameter for prediction of parametrial involvement prior to radical hysterectomy.

Purpose As more breast cancer patients opt for immediate breast reconstruction, the incidence of complications should be evaluated. The aim of this study was to analyze the recipient-site complications and flap re-explorations of immediate compared to delayed deep inferior epigastric artery perforator (DIEP) flap breast reconstructions. Methods For this multicenter retrospective cohort study, the medical records of all patients who underwent DIEP flap breast reconstruction in three hospitals in the Netherlands between January 2010 and June 2017 were reviewed. Patient demographics, risk factors, timing of reconstruction, recipient-site complications, and flap re-explorations were recorded. Results A total of 910 DIEP flap breast reconstructions (n = 397 immediate and n = 513 delayed reconstructions) in 737 patients were included. There were no significant differences in major complications or flap re-explorations between immediate and delayed reconstructions. The total flap failure rate was 1.5 and 2.5% in the immediate and delayed group, respectively. Significantly more hematomas (OR 2.91; 95% CI 1.59–5.30; p = 0.001) and seromas (OR 3.60; 95% CI 1.14–11.4; p = 0.029) occurred in immediate reconstructions, whereas wound problems were more frequently observed in delayed reconstructions (OR 1.99; 95% CI 1.27–3.11; p = 0.003). Correction for potential confounders still showed significant differences for hematoma and seroma, but no longer for wound problems (p = 0.052). Conclusions This study demonstrated similar incidences of major recipient-site complications and flap re-explorations between immediate and delayed DIEP flap breast reconstructions. However, hematoma and seroma occurred significantly more often in immediate reconstructions, while wound problems were more frequently observed in delayed reconstructions. Electronic supplementary material The online version of this article (10.1007/s10549-018-4695-0) contains supplementary material, which is available to authorized users.

Objectives Left-ventricular remodeling in women with pre-eclampsia (PE) is concentric rather than eccentric, and tends to persist postpartum, particularly after early-onset PE. This study was designed to determine whether prepregnancy cardiac geometry and function along with cardiac adaptation to the subsequent pregnancy in former early-onset PE patients differs between those who do and those who do not develop recurrent PE later on in their second pregnancy. Methods In 51 women with a history of early-onset PE, we performed serial cardiac ultrasound examinations and recorded automated measurements of blood pressure/heart rate before pregnancy and again at three consecutive times in the first half of their subsequent pregnancy. From the hospital records, we retrieved information on pregnancy outcome. We compared intergroup differences in cardiac indices using independent samples t-test, and intergroup differences in prepregnant cardiac ultrasound indices and subsequent pregnancy-induced cardiac adaptive response using repeated-measures ANOVA. Results PE recurred in 14/51 (27%) women. Preconception, the recurrent-PE group differed from the non-recurrent-PE group by having a lower left-ventricular mass (LVM) index (28 vs 32 g/m2.7, P

Pre-eclampsia (PE) is associated with both postpartum endothelial dysfunction and asymptomatic structural heart alterations consistent with heart failure Stage B (HF-B). In this study, we assessed the relationship between endothelial function, measured by flow-mediated dilation (FMD), and HF-B in women with a history of PE.This was an observational study in which 67 formerly pre-eclamptic women (≥ 4 years postpartum) and 37 healthy parous controls were assessed ultrasonographically for cardiac function and geometry, as well as for endothelial function by means of brachial artery FMD. HF-B was diagnosed as left ventricular hypertrophy (left ventricular mass index (LVMi) 95 g/mThe prevalence of HF-B amongst formerly pre-eclamptic women was three-fold higher than that observed for controls (25% vs 8%, P 0.05), while FMD was lower in formerly pre-eclamptic women compared with controls (6.12% vs 8.22%, P 0.01); history of PE remained associated independently with lower FMD after adjusting for metabolic syndrome risk factors and obstetric parameters (β, -1.88; 95% CI, -3.59 to -0.18). However, HF-B did not relate to low FMD in formerly pre-eclamptic women.Years after pregnancy, formerly pre- eclamptic women have lower FMD and have HF-B more often compared with healthy parous controls. Nonetheless, HF-B was not related to reduced FMD. Copyright © 2017 ISUOG. Published by John WileySons Ltd.

Item does not contain fulltext OBJECTIVE: To develop and internally validate a model that predicts the outcome of an intended vaginal birth after caesarean (VBAC) for a Western European population that can be used to personalise counselling for deliveries at term. DESIGN: Registration-based retrospective cohort study. SETTING: Five university teaching hospitals, seven non-university teaching hospitals, and five non-university non-teaching hospitals in the Netherlands. POPULATION: A cohort of 515 women with a history of one caesarean section and a viable singleton pregnancy, without a contraindication for intended VBAC, who delivered at term. METHODS: Potential predictors for a vaginal delivery after caesarean section were chosen based on literature and expert opinions. We internally validated the prediction model using bootstrapping techniques. MAIN OUTCOME MEASURES: Predictors for VBAC. For model validation, the area under the receiver operating characteristic curve (AUC) for discriminative capacity and calibration-per-risk-quantile for accuracy were calculated. RESULTS: A total of 371 out of 515 women had a VBAC (72%). Variables included in the model were: estimated fetal weight greater than the 90(th) percentile in the third trimester; previous non-progressive labour; previous vaginal delivery; induction of labour; pre-pregnancy body mass index; and ethnicity. The AUC was 71% (95% confidence interval, 95% CI = 69-73%), indicating a good discriminative ability. The calibration plot shows that the predicted probabilities are well calibrated, especially from 65% up, which accounts for 77% of the total study population. CONCLUSION: We developed an appropriate Western European population-based prediction model that is aimed to personalise counselling for term deliveries.

Item does not contain fulltext OBJECTIVE: To externally validate two models from the USA (entry-to-care [ETC] and close-to-delivery [CTD]) that predict successful intended vaginal birth after caesarean (VBAC) for the Dutch population. DESIGN: A nationwide registration-based cohort study. SETTING: Seventeen hospitals in the Netherlands. POPULATION: Seven hundred and sixty-three pregnant women, each with one previous caesarean section and a viable singleton cephalic pregnancy without a contraindication for an intended VBAC. METHODS: The ETC model comprises the variables maternal age, prepregnancy body mass index (BMI), ethnicity, previous vaginal delivery, previous VBAC and previous nonprogressive labour. The CTD model replaces prepregnancy BMI with third-trimester BMI and adds estimated gestational age at delivery, hypertensive disease of pregnancy, cervical examination and induction of labour. We included consecutive medical records of eligible women who delivered in 2010. For validation, individual probabilities of women who had an intended VBAC were calculated. MAIN OUTCOME MEASURES: Discriminative performance was assessed with the area under the curve (AUC) of the receiver operating characteristic and predictive performance was assessed with calibration plots and the Hosmer-Lemeshow (H-L) statistic. RESULTS: Five hundred and fifteen (67%) of the 763 women had an intended VBAC; 72% of these (371) had an actual VBAC. The AUCs of the ETC and CTD models were 68% (95% CI 63-72%) and 72% (95% CI 67-76%), respectively. The H-L statistic showed a P-value of 0.167 for the ETC model and P = 0.356 for the CTD model, indicating no lack of fit. CONCLUSION: External validation of two predictive models developed in the USA revealed an adequate performance within the Dutch population.

Introduction: Hypertensive pregnancy disorders are assumed to be preceded by defective spiral artery remodeling. Whether this localized aberration at the implantation site affects the initial maternal systemic cardiovascular and renal adaptation to pregnancy is unclear. We explored in a high-risk population, whether the initial systemic maternal adaptation to pregnancy differs between women who do and do not develop a recurrent hypertensive disorder later on in pregnancy. Methods: We enrolled 61 normotensive women with a previous hypertensive disorder of pregnancy and subdivided them into 2 subgroups, based on whether or not their next pregnancy remained uneventful (n = 33) or became complicated by a recurrent hypertensive disorder (n = 28). We measured before pregnancy and again at 18 +/- 2 weeks of gestation cardiac output, blood pressure, plasma volume, creatinine clearance, and calculated total peripheral vascular resistance from cardiac output and blood pressure. Result: Both subgroups responded to pregnancy with an increase in cardiac output, plasma volume, heart rate, and creatinine clearance, and a decrease in blood pressure and total peripheral vascular resistance. Women who developed a recurrent hypertensive disorder differed from their counterparts with an uneventful next pregnancy by smaller pregnancy-induced increases in creatinine clearance (19% vs 31%, P = .035) and cardiac output (10% vs 20%, P = .035), respectively. Conclusion: The initial systemic cardiovascular and renal adaptations to pregnancy in women who develop a recurrent gestational hypertensive disorder differ from those in their counterparts with an uneventful next pregnancy by smaller rises in creatinine clearance and cardiac output.

To describe the physiological pattern of gestational plasma volume adjustments in normal singleton pregnancy and compare this with the pattern in pregnancies complicated by pregnancy-induced hypertension, pre-eclampsia or fetal growth restriction.We performed a meta-analysis of the current literature on plasma volume adjustments during physiological and complicated pregnancies. Literature was retrieved from PubMed (NCBI) and EMBASE (Ovid) databases. Included studies reported both reference plasma volume measurements (non-pregnant, prepregnancy or postpartum) and measurements obtained during predetermined gestational ages. Mean differences bet ween the reference and pregnancy plasma volume measurements were calculated for predefined intervals of gestational age using a random-effects model described by DerSimonian and Laird.Thirty studies were included in the meta-analysis with publication dates ranging from 1934 to 2007. Plasma volume increased in the first weeks of pregnancy, with the steepest increase occurring during the second trimester. Plasma volume continued to increase in the third trimester with a pooled maximum increase of 1.13 L (95% CI, 1.07-1.19 L), an increase of 45.6% (95% CI, 43.0-48.1%) in physiological pregnancies compared with the reference value. The plasma volume expansion in gestational hypertensive and growth-restricted pregnancies was 0.80 L (95% CI, 0.59-1.02 L), an increase of 32.3% (95% CI, 23.6-41.1%) in the third trimester, a smaller increase than in physiological pregnancies (P 0.0001).During physiological pregnancy, plasma volume increases by, on average, more than 1 L as compared with non-pregnant conditions. In pregnancies complicated by pregnancy-induced hypertension, pre-eclampsia or fetal growth restriction, plasma volume increase in the third trimester is 13.3% lower than in normal pregnancy. Copyright © 2016 ISUOG. Published by John WileySons Ltd. Adaptación fisiológica del volumen del plasma materno durante el embarazo: una revisi\xF3n sistemática y metaanálisis RESUMEN OBJETIVO: Describir el patrón fisiológico de los cambios en el volumen del plasma gestacional en embarazos normales con feto único y compararlo con el patrón en los embarazos complicados por hipertensión gestacional, preeclampsia o restricción del crecimiento fetal. MÉTODOS: Se realizó un metaanálisis de la literatura actual sobre los cambios en el volumen de plasma durante embarazos complicados y fisiológicos. La literatura se obtuvo de las bases de datos PubMed (NCBI) y EMBASE (Ovid). Los estudios incluidos mencionaban tanto mediciones de referencia del volumen plasmático (no embarazada, antes del embarazo o después del parto) como mediciones tomadas a edades gestacionales predeterminadas. Se calcularon las medias de las diferencias entre las mediciones de referencia y las del embarazo para el volumen plasmático a intervalos predefinidos de la edad gestacional, utilizando un modelo de efectos aleatorios descrito por DerSimonian y Laird.En el metaanálisis se incluyeron treinta estudios con fechas de publicación entre 1934 y 2007. El volumen plasmático aumentó en las primeras semanas de embarazo y el mayor incremento se produjo durante el segundo trimestre. El volumen de plasma continuó aumentando en el tercer trimestre con un aumento combinado máximo de 1,13L (IC 95%, 1,7-1,19 L), lo que supone un aumento del 45,6% (IC 95%, 43,0-48,1%) en embarazos fisiológicas en comparación con el valor de referencia. El aumento del volumen plasmático en los embarazos con hipertensión y con crecimiento intrauterino restringido fue de 0,80L (IC 95%, 0,59-1,02 L), lo que supone un aumento del 32,3% (IC 95%, 23,6-41,1%) en el tercer trimestre, y un incremento menor que en los embarazos fisiológicos (P0,0001).Durante el embarazo fisiológico el volumen de plasma aumenta, en promedio, más de 1L, en comparación con el de las no embarazadas. En los embarazos complicados por hipertensión gestacional, preeclampsia o restricción del crecimiento fetal, el aumento del volumen plasmático en el tercer trimestre es un 13,3% menor que en el embarazo normal. :meta : ,、。 : meta。PubMed(NCBI)EMBASE(Ovid)。(、)。DerSimonianLaird,。 : Meta30,19342007。,。,1.13 L(95% CI,1.07~1.19 L),,45.6%(95% CI,43.0%~48.1%)。0.80 L(95%CI,0.59~1.02 L),32.3%(95% CI,23.6%~41.1%),(P0.0001)。 : ,,1 L。、,13.3%。.

After pre-eclampsia (PE), the prevalence of structural heart disease without symptoms, i.e. heart failure Stage B (HF-B), may be as high as one in four women in the first year postpartum. We hypothesize that a significant number of formerly pre-eclamptic women with HF-B postpartum are still in their resolving period and will not have HF-B during follow-up.In this prospective longitudinal cohort study, we included 69 formerly pre-eclamptic women who underwent serial echocardiographic measurements at 1 and 4 years postpartum. HF-B was diagnosed as left ventricular hypertrophy (left ventricular mass index (LVMi)95 g/mThe prevalence of HF-B in formerly pre-eclamptic women was 23% in the first year postpartum and 23% after 4 years. At the second visit, HF-B had resolved in 62.5% of affected women but was newly developed in 19% of initially unaffected women. At the first visit, 56% of women diagnosed with HF-B had reduced systolic function whereas at the second visit 69% of women with HF-B had concentric remodeling with mostly normal ejection fraction, consistent with diastolic dysfunction.The prevalence of HF-B can be considered consistently high (1 in 4) amongst formerly pre-eclamptic women at follow-up. Nonetheless, at an individual level, more than 60% of women found initially to be affected by HF-B will recover, whilst about 20% of formerly pre-eclamptic women with normal echocardiography in the first year postpartum will develop HF-B over the following years. Copyright © 2016 ISUOG. Published by John WileySons Ltd.

Objective: This study aims to determine the impact of using a prediction model for recurrent preeclampsia to customize antenatal care in subsequent pregnancies. Methods: We compared care consumption, pregnancy outcomes, and self-reported health state of two risk-based subgroups, and compared these to a reference group receiving standard care. Results: We included a total of 311 women from 12 hospitals. Compared to standard care, recurrence-risk guided care did not lead to different outcomes or self-perceived health. Conclusion: Our study exemplifies that recurrence-risk-based stratification of antenatal care in former preeclampsia patients is feasible; it does not lead to worse pregnancy outcomes.

To compare translabial three-dimensional (3D) ultrasound with magnetic resonance imaging (MRI) for the measurement of levator hiatal biometry at rest in women with pelvic organ prolapse, and to determine the interobserver reliability between two independent observers for ultrasound and MRI measurements.Data were derived from a multicenter prospective cohort study in which women scheduled for conventional anterior colporrhaphy underwent translabial 3D ultrasound and MRI prior to surgery. Intraclass correlation coefficients (ICCs) were calculated to estimate interobserver reliability between two independent observers and determine the agreement between ultrasound and MRI measurements. Bland-Altman plots were created to assess the agreement between ultrasound and MRI measurements.Data from 139 women from nine hospitals were included in the study. The interobserver reliability of ultrasound assessment at rest, during Valsalva maneuver and during contraction and of MRI assessment at rest were moderate or good. The agreement between ultrasound and MRI for the measurement of levator hiatal biometry at rest was moderate, with ICCs of 0.52 (95%CI, 0.32-0.66) for levator hiatal area, 0.44 (95%CI, 0.21-0.60) for anteroposterior diameter and 0.44 (95%CI, 0.22-0.60) for transverse diameter. Levator hiatal biometry measurements were statistically significantly larger on MRI than on translabial 3D ultrasound.The agreement between translabial 3D ultrasound and MRI for measurement of the levator hiatus at rest in women with pelvic organ prolapse was only moderate. The results of translabial 3D ultrasound and MRI should therefore not be used interchangeably in daily practice or in clinical research. Copyright © 2015 ISUOG. Published by John WileySons Ltd.

Item does not contain fulltext OBJECTIVE: To develop a patient decision aid (PtDA) for mode of delivery after caesarean section that integrates personalised prediction of vaginal birth after caesarean (VBAC) with the elicitation of patient preferences and evidence-based information. DESIGN: A PtDA was developed and pilot tested using the International Patients Decision Aid Standards (IPDAS) criteria. SETTING: Obstetric health care in the Netherlands. POPULATION: A multidisciplinary steering group, an expert panel, and 25 future users of the PtDA, i.e. women with a previous caesarean section. METHODS: The development consisted of a construction phase (definition of scope and purpose, and selection of content, framework, and format) and a pilot testing phase by interview. The process was supervised by a multidisciplinary steering group. MAIN OUTCOME MEASURES: Usability, clarity, and relevance. RESULTS: The construction phase resulted in a booklet including unbiased balanced information on mode of birth after caesarean section, a preference elicitation exercise, and tailored risk information, including a prediction model for successful VBAC. During pilot testing, visualisation of risks and clarity formed the main basis for revisions. Pilot testing showed the availability of tailored structured information to be the main factor involving women in decision-making. The PtDA meets 39 out of 50 IPDAS criteria (78%): 23 out of 23 criteria for content (100%) and 16 out of 20 criteria for the development process (80%). Criteria for effectiveness (n = 7) were not evaluated. CONCLUSIONS: An evidence-based PtDA was developed, with the probability of successful VBAC and the availability of structured information as key items. It is likely that the PtDA enhances the quality of decision-making on mode of birth after caesarean section.