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  • 1
    Language: English
    In: The lancet oncology, 2013, Vol.14 (3), p.210-218
    Description: Summary Background Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. Methods A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes—including operative findings, complications, mortality, and results at pathological examination—are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov , number NCT00297791. Findings The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100–400] vs 400 mL [200–700], p〈0·0001); however, laparoscopic procedures took longer (240 min [184–300] vs 188 min [150–240]; p〈0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0–3·0] vs 3·0 days [2·0–4·0]; p〈0·0001) and hospital stay was shorter (8·0 days [6·0–13·0] vs 9·0 days [7·0–14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (〈2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0–4·8] vs 3·0 cm [1·8–5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. Interpretation In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint—locoregional recurrence—are expected by the end of 2013. Funding Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.
    Subject(s): Adult ; Aged ; Aged, 80 and over ; Colorectal cancer ; Europe ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Laparoscopic surgery ; Laparoscopy ; Laparoscopy - methods ; Lymph Nodes - surgery ; Male ; Middle Aged ; Neoplasm Recurrence, Local - surgery ; Neoplasm Staging ; Rectal Neoplasms - pathology ; Rectal Neoplasms - radiotherapy ; Rectal Neoplasms - surgery ; Treatment Outcome
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
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  • 2
    Language: English
    In: The Lancet (British edition), 2007, Vol.370 (9605), p.2112-2117
    Description: Summary Background Mechanical bowel preparation is a common practice before elective colorectal surgery. We aimed to compare the rate of anastomotic leakage after elective colorectal resections and primary anastomoses between patients who did or did not have mechanical bowel preparation. Methods We did a multicentre randomised non-inferiority study at 13 hospitals. We randomly assigned 1431 patients who were going to have elective colorectal surgery to either receive mechanical bowel preparation or not. Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with either polyethylene glycol or sodium phosphate. The primary endpoint was anastomotic leakage, and the study was designed to test the hypothesis that patients who are given mechanical bowel preparation before colorectal surgery do not have a lower risk of anastomotic leakage than those who are not. The median follow-up was 24 days (IQR 17–34). We analysed patients who were treated as per protocol. This study is registered with ClinicalTrials.gov , number NCT00288496. Findings 77 patients were excluded: 46 who did not have a bowel resection; 21 because of missing outcome data; and 10 who withdrew, cancelled, or were excluded for other reasons. The rate of anastomotic leakage did not differ between both groups: 32/670 (4·8%) patients who had mechanical bowel preparation and 37/684 (5·4%) in those who did not (difference 0·6%, 95% CI −1·7% to 2·9%, p=0·69). Patients who had mechanical bowel preparation had fewer abscesses after anastomotic leakage than those who did not (2/670 [0·3%] vs 17/684 [2·5%], p=0·001). Other septic complications, fascia dehiscence, and mortality did not differ between groups. Interpretation We advise that mechanical bowel preparation before elective colorectal surgery can safely be abandoned.
    Subject(s): Abridged Index Medicus ; Aged ; Anastomosis ; Anastomosis, Surgical - adverse effects ; Anastomosis, Surgical - classification ; Colon (Anatomy) ; Colorectal Surgery - methods ; Elective Surgical Procedures ; Female ; Health aspects ; Humans ; Internal Medicine ; Length of Stay ; Male ; Medical tests ; Postoperative Complications ; Preoperative Care - methods ; Surgery ; Surgical anastomosis
    ISSN: 0140-6736
    E-ISSN: 1474-547X
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
    Source: Elsevier Journal Backfiles on ScienceDirect (DFG Nationallizenzen)
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  • 3
    Language: English
    In: Journal of allergy and clinical immunology, 2013, Vol.132 (2), p.353-360.e2
    Description: Background Subcutaneous allergen immunotherapy (SCIT) and sublingual allergen immunotherapy (SLIT) are safe and effective treatments of allergic rhinitis, but high levels of compliance and persistence are crucial to achieving the desired clinical effects. Objective Our objective was to assess levels and predictors of compliance and persistence among grass pollen, tree pollen, and house dust mite immunotherapy users in real life and to estimate the costs of premature discontinuation. Methods We performed a retrospective analysis of a community pharmacy database from The Netherlands containing data from 6486 patients starting immunotherapy for 1 or more of the allergens of interest between 1994 and 2009. Two thousand seven hundred ninety-six patients received SCIT, and 3690 received SLIT. Time to treatment discontinuation was analyzed and included Cox proportional hazard models with time-dependent covariates, where appropriate. Results Overall, only 18% of users reached the minimally required duration of treatment of 3 years (SCIT, 23%; SLIT, 7%). Median durations for SCIT and SLIT users were 1.7 and 0.6 years, respectively ( P  〈 .001). Other independent predictors of premature discontinuation were prescriber, with patients of general practitioners demonstrating longer persistence than those of allergologists and other medical specialists; single-allergen immunotherapy, lower socioeconomic status; and younger age. Of the persistent patients, 56% were never late in picking up their medication from the pharmacy. Direct medication costs per nonpersistent patient discontinuing in the third year of treatment were €3800, an amount that was largely misspent. Conclusion Real-life persistence is better in SCIT users than in SLIT users, although it is low overall. There is an urgent need for further identification of potential barriers and measures that will enhance persistence and compliance.
    Subject(s): Abridged Index Medicus ; adherence ; Administration, Sublingual ; Adult ; Allergens ; Allergens - administration & dosage ; Allergens - immunology ; Allergic reaction ; Allergic rhinitis ; Allergy ; Allergy and Immunology ; Animals ; Biological and medical sciences ; compliance ; cost ; Desensitization, Immunologic - economics ; Desensitization, Immunologic - methods ; Desensitization, Immunologic - psychology ; Female ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; Humans ; Immunotherapy ; Injections, Subcutaneous ; Male ; Medical sciences ; Middle Aged ; Netherlands ; Patient Compliance - psychology ; Patient Compliance - statistics & numerical data ; persistence ; Poaceae - immunology ; Pollen - immunology ; Pyroglyphidae ; Retrospective Studies ; Rhinitis, Allergic ; Rhinitis, Allergic, Perennial - etiology ; Rhinitis, Allergic, Perennial - therapy ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; specific allergen immunotherapy ; subcutaneous ; subcutaneous allergen immunotherapy ; sublingual ; sublingual allergen immunotherapy ; Trees - immunology
    ISSN: 0091-6749
    E-ISSN: 1097-6825
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
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  • 4
    Language: English
    In: Journal of allergy and clinical immunology, 2007, Vol.119 (4), p.892-898
    Description: Background Sublingual immunotherapy (SLIT) is considered safer and more convenient than subcutaneous therapy and therefore has been proposed as especially suitable for children and in primary care. Most efficacy studies in children lack power to be conclusive, and all have been performed in referral centers. Objective To investigate the efficacy of SLIT with grass pollen allergen in children and adolescents with rhinoconjunctivitis in a primary care setting. Methods Youngsters aged 6-18 years with hay fever were enrolled from general practices and randomly assigned to receive placebo or grass pollen mix for 2 years. The primary outcome was the mean daily total symptom score (scale 0-15) comprising sneezing, itching nose, watery running nose, nasal blockage, and itching eyes during the months May-August of the second treatment year. Results Out of 204 youngsters randomized, 168 entered the intention-to-treat analysis (91 verum, 77 placebo). The mean daily total symptom score did not differ between participants allocated to verum and those allocated to placebo (difference for verum minus placebo: −0.08, 95%CI, −0.66-0.50; P = .78). No differences were found for rescue medication–free days, disease-specific quality of life, and overall evaluation of the treatment effect. Local side effects were more frequent in the verum group (39% vs 17% of participants; P = .001). Conclusion Sublingual immunotherapy with grass pollen in a primary care setting is not effective in children and adolescents. Clinical implications Currently, SLIT cannot be recommended for general practitioners as a therapeutic modality in youngsters with grass pollen allergy.
    Subject(s): Abridged Index Medicus ; Administration, Sublingual ; Adolescent ; Allergens - administration & dosage ; Allergens - immunology ; Allergens - therapeutic use ; allergic rhinitis ; Allergy and Immunology ; Analysis ; Biological and medical sciences ; Child ; CHILDREN ; Desensitization, Immunologic ; DOUBLE-BLIND ; Double-Blind Method ; Female ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; grass pollen ; HOUSE-DUST MITE ; Humans ; Immunopathology ; Immunotherapy ; Male ; Medical sciences ; PEDIATRIC-PATIENTS ; PLACEBO-CONTROLLED EVALUATION ; Poaceae - immunology ; Pollen - immunology ; primary care ; Primary Health Care ; QUALITY-OF-LIFE ; RANDOMIZED CONTROLLED-TRIAL ; Retrospective Studies ; RHINITIS ; Rhinitis, Allergic, Seasonal - immunology ; Rhinitis, Allergic, Seasonal - therapy ; SEASONAL ALLERGIC RHINOCONJUNCTIVITIS ; sublingual ; SWALLOW IMMUNOTHERAPY
    ISSN: 0091-6749
    E-ISSN: 1097-6825
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
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  • 5
    Language: English
    In: Journal of allergy and clinical immunology, 2013, Vol.132 (2), p.482-485.e10
    Description: Byline: E. Marije Bakker (a), Els C. van der Wiel-Kooij (a), Bernhard Mullinger (b), Philipp Kroneberg (b), Wim C.J. Hop (c), Harm A.W.M. Tiddens (a) Author Affiliation: (a) Department of Pediatric Pulmonology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands (b) Activaero GmbH, Gemunden, Germany (c) Department of Biostatistics, Erasmus MC, Rotterdam, The Netherlands Article Note: (footnote) Supported by Roche Netherlands B.V., Stichting Vrienden van het Sophia (Friends of Sophia Children's Hospital Foundation), Stichting Astma Bestrijding (Dutch Fund for Asthma), and Activaero GmbH. Roche BV Netherlands supplied dornase alfa for use in this study free of charge., Disclosure of potential conflict of interest: E. M. Bakker has been supported by one or more grants from Stichting Astma Bestrijding. B. Mullinger is employed by, has one or more patents (planned, pending, or issued) with, and owns stock/stock options in Activaero. P. Kroneberg is employed by and has one or more patents (planned, pending, or issued) with Activaero. A. W. M. Tiddens has been supported by one or more grants from Roche Pharmaceuticals; has consultancy arrangements with Gilead, Novartis, Pharmaxis, Insmed, and Siemens; is employed by the University of Washington (Visiting Professorship [grant by CFF]) and by the University of Cincinnati (Visiting Professorship [grant by CFF]); has received one or more payments for lecturing from or is on the speakers' bureau for Roche, Gilead, and Novartis; and has a combined patent on specific targeting with DNase. The rest of the authors declare that they have no relevant conflicts of interest.
    Subject(s): Abridged Index Medicus ; Adolescent ; Airway Obstruction - drug therapy ; Airway Obstruction - physiopathology ; Allergy and Immunology ; Asthma - complications ; Asthma - drug therapy ; Asthma - physiopathology ; Asthma in children ; Biological and medical sciences ; Child ; Deoxyribonuclease I - metabolism ; Deoxyribonuclease I - therapeutic use ; Dornase alfa ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; Humans ; Male ; Maximal Midexpiratory Flow Rate ; Medical sciences ; Nebulizers and Vaporizers ; Recombinant Proteins - metabolism ; Recombinant Proteins - therapeutic use ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; Treatment Outcome
    ISSN: 0091-6749
    E-ISSN: 1097-6825
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
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  • 6
    Language: English
    In: The lancet oncology, 2009, Vol.10 (8), p.764-771
    Description: Summary Background Phaeochromocytomas and paragangliomas are neuro-endocrine tumours that occur sporadically and in several hereditary tumour syndromes, including the phaeochromocytoma–paraganglioma syndrome. This syndrome is caused by germline mutations in succinate dehydrogenase B ( SDHB ), C ( SDHC ), or D ( SDHD ) genes. Clinically, the phaeochromocytoma–paraganglioma syndrome is often unrecognised, although 10–30% of apparently sporadic phaeochromocytomas and paragangliomas harbour germline SDH -gene mutations. Despite these figures, the screening of phaeochromocytomas and paragangliomas for mutations in the SDH genes to detect phaeochromocytoma–paraganglioma syndrome is rarely done because of time and financial constraints. We investigated whether SDHB immunohistochemistry could effectively discriminate between SDH -related and non- SDH -related phaeochromocytomas and paragangliomas in large retrospective and prospective tumour series. Methods Immunohistochemistry for SDHB was done on 220 tumours. Two retrospective series of 175 phaeochromocytomas and paragangliomas with known germline mutation status for phaeochromocytoma-susceptibility or paraganglioma-susceptibility genes were investigated. Additionally, a prospective series of 45 phaeochromocytomas and paragangliomas was investigated for SDHB immunostaining followed by SDHB, SDHC , and SDHD mutation testing. Findings SDHB protein expression was absent in all 102 phaeochromocytomas and paragangliomas with an SDHB, SDHC , or SDHD mutation, but was present in all 65 paraganglionic tumours related to multiple endocrine neoplasia type 2, von Hippel–Lindau disease, and neurofibromatosis type 1. 47 (89%) of the 53 phaeochromocytomas and paragangliomas with no syndromic germline mutation showed SDHB expression. The sensitivity and specificity of the SDHB immunohistochemistry to detect the presence of an SDH mutation in the prospective series were 100% (95% CI 87–100) and 84% (60–97), respectively. Interpretation Phaeochromocytoma–paraganglioma syndrome can be diagnosed reliably by an immunohistochemical procedure. SDHB, SDHC , and SDHD germline mutation testing is indicated only in patients with SDHB-negative tumours. SDHB immunohistochemistry on phaeochromocytomas and paragangliomas could improve the diagnosis of phaeochromocytoma–paraganglioma syndrome. Funding The Netherlands Organisation for Scientific Research, Dutch Cancer Society, Vanderes Foundation, Association pour la Recherche contre le Cancer, Institut National de la Santé et de la Recherche Médicale, and a PHRC grant COMETE 3 for the COMETE network.
    Subject(s): Adolescent ; Adrenal Gland Neoplasms - diagnosis ; Adrenal Gland Neoplasms - genetics ; Adult ; Aged ; Blotting, Western ; Child ; Developmental biology ; DNA Mutational Analysis ; Female ; Gene mutations ; Genetic aspects ; Genetic research ; Germ-Line Mutation ; Hematology, Oncology and Palliative Medicine ; Human genetics ; Humans ; Hypertension ; Immunohistochemistry ; Immunohistochemistry - methods ; Male ; Membrane Proteins - genetics ; Middle Aged ; Molecular genetics ; Paraganglioma - diagnosis ; Paraganglioma - genetics ; Pheochromocytoma - diagnosis ; Pheochromocytoma - genetics ; Succinate Dehydrogenase - genetics ; Syndrome ; Tumors ; Universities and colleges ; Young Adult
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
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