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Lamers B.H.C.,Erasmus Medical Center | Milani A.L.,Reinier Of Graaf Group
International Urogynecology Journal and Pelvic Floor Dysfunction | Year: 2011

Pessaries have been used to treat women with pelvic organ prolapse (POP) since the beginning of recorded history. This review aims to assess the effect of pessary treatment on the disease-specific, health-related quality of life in women with pelvic organ prolapse. After a Medline search using the Mesh term 'pessary' and critical appraisal, 41 articles were selected and used in this review. Pessaries are widely used to treat pelvic organ prolapse. It is minimally invasive and appears to be safe. Although there is evidence that the use of pessaries in the treatment of pelvic organ prolapse is effective in alleviating symptoms and that patient satisfaction is high, the follow-up in many published papers is short, and the use of validated urogynaecological questionnaires is limited. Comparison with surgical treatment of pelvic organ prolapse is rare and not assessed in a randomised controlled trial. © The Author(s) 2011.


Withagen M.I.J.,Radboud University Nijmegen | Vierhout M.E.,Radboud University Nijmegen | Milani A.L.,Reinier Of Graaf Group
International Urogynecology Journal and Pelvic Floor Dysfunction | Year: 2010

Introduction and hypothesis: The objective of this study was to assess the effect of the tension-free vaginal mesh (Prolift™) procedure on the non-treated and initially unaffected vaginal compartments. Methods: This prospective observational cohort study involved 150 patients who underwent a Prolift™ procedure. Pelvic organ prolapse (POP) quantification and evaluation of prolapse symptoms with validated questionnaires was performed pre-operatively and 6 and 12 months postoperatively. Primary outcome was the rate of POP stage ≥II in the non-treated vaginal compartments. Results: Twenty-three percent of all patients developed a de novo POP stage ≥II in the untreated compartment. This occurred in 46% and 25% of patients after an isolated anterior and isolated posterior Prolift™, respectively. Conclusion: Tension-free vaginal mesh treatment of one vaginal compartment seems to provoke the development of vaginal prolapse in initially unaffected vaginal compartments, particularly after an isolated anterior Prolift™ procedure.


Milani A.L.,Reinier Of Graaf Group | Hinoul P.,ETHICON,Inc. | Gauld J.M.,ETHICON,Inc. | Sikirica V.,ETHICON,Inc. | And 2 more authors.
American Journal of Obstetrics and Gynecology | Year: 2011

OBJECTIVE: To evaluate anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh. STUDY DESIGN: Prospective multicentre cohort study at 11 international sites. One hundred twenty-seven patients with pelvic organ prolapse stage ≥ III had surgery and were evaluated at 3 months and 1-year postsurgery compared with baseline. Instruments of measurements: Pelvic Organ Prolapse Quantification, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12, and Patients Global Impression of Change. RESULTS: Anatomic success, defined as prolapse stage ≤ I in the treated vaginal compartments, was 77.4% (95% confidence interval, 69.084.4%). Significant improvements in bother, quality of life, and sexual function were detected at 3 months and 1 year compared with baseline. At 1-year after surgery, 86.2% of patients indicated their prolapse situation to be "much better." Mesh exposure rate was 10.2% and rate of de novo dyspareunia 2% at 1 year. CONCLUSION: These results demonstrate improved anatomic support, associated with excellent functional improvements, without apparent safety concerns. © 2011 Mosby, Inc.


Withagen M.I.,Radboud University Nijmegen | Milani A.L.,Reinier Of Graaf Group | De Leeuw J.W.,Ikazia Hospital | Vierhout M.E.,Radboud University Nijmegen
BJOG: An International Journal of Obstetrics and Gynaecology | Year: 2012

Objective To compare the de novo prolapse rate in the untreated vaginal compartments following conventional vaginal prolapse repair and tension-free vaginal mesh repair. Design Secondary analysis of a randomised controlled trial. Setting Thirteen centres in the Netherlands. Population Women with recurrent pelvic organ prolapse stage II or higher. Methods Random assignment to either conventional vaginal native tissue repair or vaginal mesh insertion. Main outcome measures Primary outcome: de novo pelvic organ prolapse stage II or higher in the untreated vaginal compartments at 12 months after surgery. Secondary outcomes: de novo pelvic organ prolapse at and beyond the hymen, de novo prolapse beyond the hymen and prolapse domain scores of the Urogenital Distress Inventory. Results At 12 months ten of 59 women (17%) in the conventional group versus 29 of 62 women (47%) in the mesh group were diagnosed with a de novo pelvic organ prolapse stage II or higher in the untreated compartment (P < 0.001, odds ratio 4.3, 95% confidence interval 1.9-10.0). Additional apical support to a mesh-augmented anterior repair significantly reduced the de novo prolapse rate. Women with a de novo prolapse in the mesh-treated group demonstrated significantly higher mean bother scores on the domain genital prolapse of the Urogenital Distress Inventory score (13.1 ± 24.2) compared with those without de novo prolapse (2.9 ± 13.9) (P = 0.03). Conclusion Mesh-augmented prolapse repair in only one vaginal compartment is associated with a higher de novo prolapse rate in the untreated compartments compared with conventional vaginal native tissue repair in women with recurrent pelvic organ prolapse. © 2012 RCOG.


Gerth Van Wijk R.,Erasmus University Rotterdam | Patiwael J.A.,Erasmus University Rotterdam | De Jong N.W.,Erasmus University Rotterdam | De Groot H.,Reinier Of Graaf Group | Burdorf A.,Erasmus University Rotterdam
Allergy: European Journal of Allergy and Clinical Immunology | Year: 2011

Background: Avoidance of occupational allergens or reduction in exposure has been advocated as the mainstay of the management of occupational rhinitis. Sparse data to the effect of allergen avoidance are available. Objective: To identify factors that may lead to leaving work and to address the effect of subsequent allergen avoidance on quality of life. Methods: A survey to the prevalence of occupational allergy to bell pepper performed in 1999 comprised 472 employees, of which 254 had work-related rhinitis and 228 completed the Rhinitis-related Quality of Life Questionnaire. After 8-year follow-up in 2007, 91 workers with rhinitis in 1999 were available to fill out the questionnaire again and were used to evaluate the course of nasal disease in terms of perceived severity and impact on daily life. Results: Workers with rhinitis at baseline were more likely to leave their job in bell pepper cultivation for another job (OR = 1.62, 95% CI 0.95-2.75). Among the 91 workers, 58 subjects were still at work, whereas 33 subjects had left work. The subjects who left jobs reported substantial improvement in quality of life. The magnitude of the changes ranged from -0.31 to -1. The effect of quitting work on the mean quality of life score amounted -0.76 ± 0.15. Conclusions: The current study is the first large longitudinal studies showing that leaving work and subsequent occupational allergen avoidance have a beneficial effect on rhinitis-related quality of life. The study suggests that occupational rhinitis can be a reason to leave work. © 2011 John Wiley & Sons A/S.


Kunneman M.,Leiden University | Marijnen C.A.M.,Leiden University | Rozema T.,Verbeeten Institute | Ceha H.M.,Radiotherapy Center West | And 4 more authors.
British Journal of Cancer | Year: 2015

Background: For shared decision making to be successful, patients should receive sufficient information on possible benefits and harms of treatment options. The aim of this study was to evaluate what information radiation oncologists provide during the decision consultation about preoperative radiotherapy with rectal cancer patients. Methods: Decision consultations of 17 radiation oncologists with 81 consecutive primary rectal cancer patients, eligible for short-course radiotherapy followed by a low-anterior resection, were audio taped. Tapes were transcribed and analysed using the ACEPP (Assessing Communication about Evidence and Patient Preferences) coding scheme. Results: A median of seven benefits/harms were addressed per consultation (range, 2-13). This number ranged within and between oncologists and was not clearly associated with the patient's characteristics. A total of 30 different treatment outcomes were addressed. The effect of radiotherapy on local control was addressed in all consultations, the effect on survival in 16%. The most important adverse effects are bowel and sexual dysfunction. These were addressed in 82% and 85% of consultations, respectively; the latter significantly less often in female than in male patients. Four out of five patients did not initiate discussion on any benefits/harms. Conclusions: Our results showed considerable inconsistency between and within oncologists in information provision, which could not be explained by patient characteristics. This variation indicates a lack of clarity on which benefits/harms of radiotherapy should be discussed with newly-diagnosed patients. This suboptimal patient information hampers the process of shared decision making, in which the decision is based on each individual patients' weighing of benefits and harms. © 2015 Cancer Research UK.


Van Hove P.D.,Technical University of Delft | Van Hove P.D.,Reinier Of Graaf Group | Van Hove P.D.,Maastricht University | Tuijthof G.J.M.,Technical University of Delft | And 4 more authors.
British Journal of Surgery | Year: 2010

Background: Surgeons are increasingly being scrutinized for their performance and there is growing interest in objective assessment of technical skills. The purpose of this study was to review all evidence for these methods, in order to provide a guideline for use in clinical practice. Method: A systematic search was performed using PubMed and Web of Science for studies addressing the validity and reliability of methods for objective skills assessment within surgery and gynaecology only. The studies were assessed according to the Oxford Centre for Evidence-based Medicine levels of evidence. Result: In total 104 studies were included, of which 20 (19-2 percent) had a level of evidence 1b or 2b. In 28 studies (26-9 per cent), the assessment method was used in the operating room. Virtual reality simulators and Objective Structured Assessment of Technical Skills (OSATS) have been studied most. Although OSATS is seen as the standard for skills assessment, only seven studies, with a low level of evidence, addressed its use in the operating room. Concluasion: Based on currently available evidence, most methods of skills assessment are valid for feedback or measuring progress of training, but few can be used for examination or credentialing. The purpose of the assessment determines the choice of method. Copyright © 2010 British Journal of Surgery Society Ltd.


Lagarde S.M.,Saint Lucas Andreas Hospital | Vrouenraets B.C.,Saint Lucas Andreas Hospital | Stassen L.P.S.,Reinier Of Graaf Group | van Lanschot J.J.B.,Erasmus Medical Center
Annals of Thoracic Surgery | Year: 2010

Evidence-based medicine is the conscientious, explicit, and judicious use of best available evidence in making decisions for individual patient care. The present review gives an evidence-based review of esophageal cancer surgery. The literature search was restricted to the highest level of evidence on the surgical treatment of esophageal cancer. © 2010 The Society of Thoracic Surgeons.


Lensen E.J.M.,Radboud University Nijmegen | Withagen M.I.J.,Radboud University Nijmegen | Kluivers K.B.,Radboud University Nijmegen | Milani A.L.,Reinier Of Graaf Group | Vierhout M.E.,Radboud University Nijmegen
Neurourology and Urodynamics | Year: 2013

Aims This study focused on the changes in urinary incontinence (UI) rates pre- and postoperatively and identified risk factors which predict the presence of symptoms of urgency urinary incontinence (UUI) or stress urinary incontinence (SUI) after surgery for pelvic organ prolapse (POP) without concomitant or previous anti-incontinence surgery. Methods All consecutive women who underwent POP surgery without concomitant or previous anti-incontinence surgery in the years 2004-2010 were included. Assessments were performed preoperatively and at 1-year follow-up, including pelvic organ prolapse quantification score and a standardized urogynecological questionnaire (Urogenital Distress Inventory, UDI). Primary outcome of this study was stress and/or urgency UI postoperatively. Furthermore, this study measured the improvement or worsening of UI following surgery using the UDI. Univariable- and multivariable logistic regression with forward selection procedure was used to identify the risk factors. Results Nine hundred seven patients were included. De novo SUI appeared in 22% and de novo UUI occurred in 21% of the women. At 1-year 42% were cured for UUI and 39% were recovered from SUI by POP surgery alone. The best predictor for the occurrence of postoperative SUI or UUI was the presence of preoperative SUI or UUI. BMI and chronic obstructive pulmonary disease (COPD) were identified as independent risk factors for postoperative SUI. A recurrence in the anterior compartment protected against SUI postoperatively. Conclusions Preoperative SUI or UUI is the most important predictor of SUI and UUI postoperatively. BMI and COPD were identified as important risk factors for SUI. Copyright © 2012 Wiley Periodicals, Inc.


Milani A.L.,Reinier Of Graaf Group | Withagen M.I.J.,Radboud University Nijmegen | Vierhout M.E.,Radboud University Nijmegen
American Journal of Obstetrics and Gynecology | Year: 2012

Objective: The objective of the study was to compare the 1 year conventional and composite outcomes of trocar-guided vaginal mesh surgery and the identification of the predictors of failure. Study Design: This was a prospective observational cohort study. Failure outcome definitions were as follows: I, prolapse stage II or greater in mesh treated compartments; II, overall prolapse stage II or greater; III, composite outcome of overall prolapse greater than the hymen and the presence of bulge symptoms or repeat surgery. We used logistic regression to identify predictors of failure. Results: The results of the study were 1 year follow-up of 433 patients. Treated compartment failure (I) was 15% (95% confidence interval [CI], 12-19). Overall prolapse failure (II) was 41% (95% CI, 36-45). Composite failure (III) was 9% (95% CI, 7-13). Predictor of failure in all outcomes was the combined anterior/posterior mesh with the uterus in situ. Conclusion: Outcome of prolapse surgery depends on outcome definition. The mesh treated compartment failure outcome (I) and the composite failure outcome (III) appeared not to be statistically different. Consistent factor for failure in all outcomes was the combined anterior/posterior mesh insertion with the uterus in situ. © 2012 Mosby, Inc.

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