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1.
Cureus ; 15(4): e37318, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37181957

RESUMO

Introduction To provide high-quality surgical care, surgeons must critically appraise medical literature to adapt their clinical practice whenever convincing evidence emerges. This will promote evidence-based surgery (EBS). Over the last decade, we have organized monthly journal clubs (JCs) and more extensive quarterly EBS courses for surgical residents and PhD students, supervised by surgical staff. We evaluated the participation, satisfaction, and knowledge gained by this EBS program, to make the program future-proof and aid other educators. Materials and methods An anonymous digital survey was distributed via email among residents, PhD students, and surgeons of the Amsterdam University Medical Centers' (UMC) surgical department in April 2022. The survey included general questions on EBS education, specific course-oriented questions for the residents and PhD students, and questions about supervision for surgeons. Results The survey was completed by 47 respondents from the surgery department of the Amsterdam UMC University Hospital, of whom 63.8% (n=30) were residents or PhD students and 36.2% (n=17) were surgeons. During one year of the combined EBS course and JCs, the EBS course was attended by 40.0% (n=12) of PhD students and was rated with a mean score of 7.6/10. JCs were attended by 86.6% (n=26) of residents or PhD students and received a mean score of 7.4/10. Reported strengths of the JCs were their easy accessibility and the acquisition of critical appraisal skills and scientific knowledge. A reported point of improvement was to focus more deeply on specific epidemiological topics per meeting. Of the surgeons, 64.7% (n=11) had supervised at least one JC and gave a mean score of 8.5/10. The main reasons to supervise JCs were the distribution of knowledge (45.5%), scientific discussion (36.3%), and contact with PhD students (18.1%). Conclusion Our EBS educational program, including JCs and EBS courses, was well appreciated by residents, PhD students, and staff. This format is advocated for other centers aiming to better implement EBS in surgical practice.

2.
Trials ; 22(1): 639, 2021 Sep 19.
Artigo em Inglês | MEDLINE | ID: mdl-34538275

RESUMO

BACKGROUND: Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200-220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe. METHODS: Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200-220 s. If the ACT after 5 min is < 180 s, 60 IU/kg will be administered; if the ACT is between 180 and 200 s, 30 IU/kg. If the ACT is > 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group. DISCUSSION: The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. TRIAL REGISTRATION {2A}: NTR NL8421 ClinicalTrials.gov NCT04061798 . Registered on 20 August 2019 EudraCT 2018-003393-27 TRIAL REGISTRATION: DATA SET {2B}: Data category Information Primary registry and trial identifying number ClinicalTrials.gov : NCT04061798 Date of registration in primary registry 20-08-2019 Secondary identifying numbers NTR: NL8421 EudraCT: 2018-003393-27 Source(s) of monetary or material support ZonMw: The Netherlands Organisation for Health Research and Development Dijklander Ziekenhuis Amsterdam UMC Primary sponsor Dijklander Ziekenhuis Secondary sponsor(s) N/A Contact for public queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Contact for scientific queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Public title ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair (ACTION-1) Scientific title ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial Countries of recruitment The Netherlands. Soon the recruitment will start in Germany Health condition(s) or problem(s) studied Abdominal aortic aneurysm, arterial disease, surgery Intervention(s) ACT-guided heparinization 5000 IU of heparin Key inclusion and exclusion criteria Ages eligible for the study: ≥18 years Sexes eligible for the study: both Accepts healthy volunteers: no Inclusion criteria: Study type Interventional Allocation: randomized Intervention model: parallel assignment Masking: single blind (patient) Primary purpose: treatment Phase IV Date of first enrolment March 2020 Target sample size 750 Recruitment status Recruiting Primary outcome(s) The primary efficacy endpoint is 30-day mortality and in-hospital mortality during the same admission. The primary safety endpoint is the incidence of bleeding complications according to E-CABG classification, grade 1 and higher. Key secondary outcomes Serious complications as depicted in the Suggested Standards for Reports on Aneurysmal disease: all complications requiring re-operation, longer hospital stay, all complications.


Assuntos
Aneurisma da Aorta Abdominal , COVID-19 , Adolescente , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Heparina/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Método Simples-Cego , Resultado do Tratamento
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