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"Simons, Maarten"
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Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial
2018
Both mesh and suture repair are used for the treatment of umbilical hernias, but for smaller umbilical hernias (diameter 1–4 cm) there is little evidence whether mesh repair would be beneficial. In this study we aimed to investigate whether use of a mesh was better in reducing recurrence compared with suture repair for smaller umbilical hernias.
We did a randomised, double-blind, controlled multicentre trial in 12 hospitals (nine in the Netherlands, two in Germany, and one in Italy). Eligible participants were adults aged at least 18 years with a primary umbilical hernia of diameter 1–4 cm, and were randomly assigned (1:1) intraoperatively to either suture repair or mesh repair. In the first 3 years of the inclusion period, blocked randomisation (of non-specified size) was achieved by an envelope randomisation system; after this time computer-generated randomisation was introduced. Patients, investigators, and analysts were masked to the allocated treatment, and participants were stratified by hernia size (1–2 cm and >2–4 cm). At study initiation, all surgeons were invited to training sessions to ensure they used the same standardised techniques for suture repair or mesh repair. Patients underwent physical examinations at 2 weeks, and 3, 12, and 24–30 months after the operation. The primary outcome was the rate of recurrences of the umbilical hernia after 24 months assessed in the modified intention-to-treat population by physical examination and, in case of any doubt, abdominal ultrasound. This trial is registered with ClinicalTrials.gov, number NCT00789230.
Between June 21, 2006, and April 16, 2014, we randomly assigned 300 patients, 150 to mesh repair and 150 to suture repair. The median follow-up was 25·1 months (IQR 15·5–33·4). After a maximum follow-up of 30 months, there were fewer recurrences in the mesh group than in the suture group (six [4%] in 146 patients vs 17 [12%] in 138 patients; 2-year actuarial estimates of recurrence 3·6% [95% CI 1·4–9·4] vs 11·4% (6·8–18·9); p=0·01, hazard ratio 0·31, 95% CI 0·12–0·80, corresponding to a number needed to treat of 12·8). The most common postoperative complications were seroma (one [<1%] in the suture group vs five [3%] in the mesh group), haematoma (two [1%] vs three [2%]), and wound infection (one [<1%] vs three [2%]). There were no anaesthetic complications or postoperative deaths.
This is the first study showing high level evidence for mesh repair in patients with small hernias of diameter 1–4 cm. Hence we suggest mesh repair should be used for operations on all patients with an umbilical hernia of this size.
Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
Journal Article
Single Fascia Iliaca Compartment Block is Safe and Effective for Emergency Pain Relief in Hip-fracture Patients
by
Groot, Leonieke
,
Rebel, Jasper
,
Zwartsenburg, Mariska
in
Aged
,
analgesia
,
Analgesics, Opioid - therapeutic use
2015
Currently, it is common practice in the emergency department (ED) for pain relief in hip-fracture patients to administer pain medication, commonly systemic opioids. However, with these pain medications come a high risk of side effects, especially in elderly patients. This study investigated the safety profile and success rate of fascia iliaca compartment block (FICB) in a busy ED. This ED was staffed with emergency physicians (EPs) and residents of varying levels of experience. This study followed patients' pain levels at various hourly intervals up to eight hours post procedure.
Between September 2012 and July 2013, we performed a prospective pilot study on hip-fracture patients who were admitted to the ED of a teaching hospital in the Netherlands. These patients were followed and evaluated post FICB for pain relief. Secondary outcome was the use of opioids as rescue medication.
Of the 43 patients in this study, patients overall experienced less pain after the FICB (p=0.04). This reduction in pain was studied in conjunction with the use and non-use of opioids. A clinically meaningful decrease in pain was achieved after 30 minutes in 62% of patients (54% with the use of opioids, 8% without opioids); after 240 minutes in 82% of patients (18% with opioids, 64% without opioids); after 480 minutes in 88% of patients (16% with opioids, 72% without opioids). No adverse events were reported.
In a busy Dutch ED with rotating residents of varying levels of experience, FICB seems to be an efficient, safe and practical method for pain reduction in patients with a hip fracture. Even without the use of opioids, pain reduction was achieved in 64% of patients after four hours and in 72% of patients after eight hours.
Journal Article
Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial
by
Simmermacher, Rogier K. J.
,
Frederix, Geert W. J.
,
Verleisdonk, Egbert-Jan M. M.
in
Abdominal Pain - diagnosis
,
Abdominal Pain - etiology
,
Biomedicine
2018
Background
Groin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain.
The objective of this study is to assess whether watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia.
Methods
The EFFECT study is a multicenter non-blinded randomized controlled non-inferiority trial. Adult patients with unilateral groin pain and a clinically occult inguinal hernia are eligible to participate in this study. A total of 160 participants will be included and randomized to TEP inguinal hernia repair or a watchful waiting approach. The primary outcome of this study is pain reduction 3 months after treatment, measured by the Numeric Rating Scale (NRS). Secondary outcomes are quality of life, cost-effectiveness, patient satisfaction and crossover rate. Eight surgical centers will take part in the study. Participants will be followed-up for 1 year.
Discussion
This is the first large randomized controlled trial comparing treatments for patients with groin pain and a clinically occult inguinal hernia. To date, there are no interventional studies on the effect of surgery or a watchful waiting approach in terms of pain or quality of life in this subset of patients. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. If watchful waiting is not inferior to surgical repair, costs of surgical repair may be saved.
Trial registration
The study protocol (NL61730.100.17) is approved by the Medical Ethics Committee (MEC-U) of the Diakonessenhuis, Utrecht, The Netherlands. The study was registered at the Netherlands Trial Registry (
NTR6835
) registered on November 13, 2017.
Journal Article
THE GOVERNMENTALIZATION OF LEARNING AND THE ASSEMBLAGE OF A LEARNING APPARATUS
2008
In this essay, Maarten Simons and Jan Masschelein reconsider the concepts “educationalization” and “the grammar of schooling” in the light of the overwhelming importance of “learning” today. Doubting whether these concepts and related historical‐analytical perspectives are still useful, the authors suggest the concept “learning apparatus” as a point of departure for an analysis of the “grammar of learning.” They draw on Michel Foucault’s analysis of governmentality to describe how learning has become a matter of both government and self‐government. In describing the governmentalization of learning and the current assemblage of a ”learning apparatus,” Simons and Masschelein indicate how the concept of learning has become disconnected from education and teaching and has instead come to refer to a kind of capital, to something for which the learner is personally responsible, to something that can and should be managed, and to something that must be employable. Finally, the authors elaborate how these discourses combine to play a crucial role in contemporary advanced liberalism that seeks to promote entrepreneurship.
Journal Article
Validation of the Emergency Severity Index (ESI) in self-referred patients in a European emergency department
2007
Objective: To validate the Emergency Severity Index (ESI) triage algorithm in predicting resource consumption and disposition by self-referred patients in a European emergency department. Methods: This was a prospective, observational cohort study using a convenience sample of self-referred emergency department patients >14 years of age presenting to a busy urban teaching hospital during a 39-day period (27 May–4 July 2001). Observed resource use was compared with resource utilisation predicted by the ESI. Outpatient referrals after discharge and hospitalisations were also recorded. Results: ESI levels were obtained in 1832/3703 (50%) self-referred patients, most of whom were in the less severe ESI-4 (n = 685, 37%) and ESI-5 (n = 983, 54%) categories. Use of resources was strongly associated with the triage level, rising from 15% in ESI-5 to 97% in ESI-2 patients. Specialty consultations and admissions also rose with increasing ESI severity. Only 5% of ESI-5 patients required consultation and <1% were admitted, whereas 85% of ESI-2 patients received a consultation and 56% were admitted, 26% to a critical care bed. Only 2% of the ESI-5 patients underwent blood tests, compared with 76% of the sicker ESI-2 patients. x Rays were the most commonly used resource in patients triaged to ESI-4 and ESI-5. Conclusion: The ESI triage category reliably predicts the severity of a patient’s condition, as reflected by resource utilisation, consultations and admissions in a population of self-referred patients in a European emergency department. It clearly identifies patients who require minimal resources, or at most an x ray, and those unlikely to require admission.
Journal Article
What is Negotiated in Negotiated Accountability? The Case of INGOs
by
Simons, Maarten
,
Vandenabeele, Joke
,
Berghmans, Mieke
in
Accountability
,
Beneficiaries
,
Concept formation
2017
This paper discusses the constructivist, negotiated perspective to INGO accountability. According to this perspective, INGO accountability is a process of mutual negotiations between different INGO stakeholders who hold different accountability demands. Acknowledging that this perspective provides a good starting point for a better understanding of INGO accountability, we comment on this conceptualization of INGO accountability. Through an analysis of accountability instruments and procedures, we examine closely how the demands of the INGO's stakeholders are embedded in particular relationships of accountability which are sustained by particular accountability logics. From this analysis, we point out that, due to the differences that exist between these accountability logics, processes of negotiation are likely to be filled with complex tensions and trade-offs. Moreover, as some accountability logics are much clearer and more compelling than others, a constructivist perspective on INGO accountability does not automatically coincide with an understanding of INGO accountability in which primordial importance is given to the beneficiaries. Cet article traite du cadre constructiviste et négocié de la reddition de comptes des ONGI. Selon ce cadre, la responsabilité des ONGI relève d'un processus de négociations mutuelles entre divers intervenants connexes ayant des demandes variées en matière de reddition de comptes. Tout en admettant que ce cadre offre un bon point de départ pour mieux comprendre la responsabilité des ONGI, nous avançons un commentaire sur la conceptualisation de cette dernière. Dans le cadre d'une analyse des instruments et procédures de reddition de comptes, nous examinons étroitement la façon dont les demandes des intervenants des ONGI sont intégrées à des relations de responsabilisation données préservées par des logiques connexes précises. À partir de cette analyse, nous avançons que, en raison des différences qui existent entre ces logiques, les processus de négociation seront vraisemblablement parsemés de tensions et compromis complexes. Qui plus est, puisque des logiques de responsabilisation sont beaucoup plus claires et attrayantes que d'autres, un cadre constructiviste de la reddition de comptes des ONGI ne coïncide pas automatiquement avec la compréhension du concept voulant que l'importance soit donnée aux bénéficiaires. In diesem Beitrag wird die konstruktivistische, verhandelte Perspektive hinsichtlich der Rechenschaftspflicht internationaler nicht-staatlicher Organisationen diskutiert. Gemäß dieser Perspektive handelt es sich bei der Rechenschaftspflicht internationaler nicht-staatlicher Organisationen um einen Prozess einvernehmlicher Verhandlungen zwischen verschiedenen Stakeholdern der Organisationen, die unterschiedliche Rechenschaftsforderungen stellen. Wir räumen ein, dass diese Perspektive einen guten Ausgangspunkt für ein besseres Verständnis der Rechenschaftspflicht dieser Organisationen bietet und kommentieren die Konzeptualisierung der Rechenschaftspflicht. Mittels einer Analyse der Rechenschaftsinstrumente und -verfahren wird geprüft, wie die Forderungen der Stakeholder dieser Organisationen in bestimmten Rechenschaftsbeziehungen, die von gewissen Rechenschaftslogiken aufrechterhalten werden, eingelagert sind. Die Analyse zeigt, dass die Verhandlungsprozesse aufgrund der Unterschiede zwischen diesen Rechenschaftlogiken von komplexen Spannungen und Kompromissen gekennzeichnet sein dürften. Da darüber hinaus einige Rechenschaftslogiken sehr viel klarer und verpflichtender sind als andere, geht eine konstruktivistische Perspektive zur Rechenschaftspflicht internationaler nicht-staatlicher Organisationen nicht automatisch mit einem Verständnis dieser Rechenschaftspflicht einher, in der den Nutzträgern die größte Bedeutung beigemessen wird. El presente documente trata de la perspectiva constructivista negociada de la responsabilidad de las Organizaciones No Gubernamentales Internacionales (INGO, por sus siglas en inglés). Según esta perspectiva, la responsabilidad de una INGO es un proceso de negociaciones mutuas entre las diferentes partes interesadas de la INGO que mantienen exigencias de responsabilidad diferentes. Reconociendo que esta perspectiva proporciona un buen punto de inicio para una mejor comprensión de la responsabilidad de las INGO, comentamos esta conceptualización de la responsabilidad de las INGO. Mediante un análisis de los instrumentos y procedimientos sobre la responsabilidad, examinamos muy de cerca cómo las exigencias de las partes interesadas de las INGO están incorporadas en relaciones particulares de responsabilidad que están sustentadas por una lógica de la responsabilidad específica. A partir de estos análisis, señalamos que, debido a las diferencias que existen entre estas lógicas de responsabilidad, es probable que los procesos de negociación sean cumplimentados con tensiones y compensaciones complejas. Asimismo, dado que algunas lógicas de responsabilidad son mucho más claras y más persuasivas que otras, una perspectiva constructivista sobre la responsabilidad de las INGO no coincide automáticamente con una comprensión de la responsabilidad de las INGO en la que se dé una importancia primordial a los beneficiarios.
Journal Article
Consensus on international guidelines for management of groin hernias
by
Bittner Reinhard
,
Van den Heuvel Baukje
,
Klinge Uwe
in
Antibiotics
,
Endoscopy
,
Evidence-based medicine
2020
BackgroundGroin hernia management has a significant worldwide diversity with multiple surgical techniques and variable outcomes. The International guidelines for groin hernia management serve to help in groin hernia management, but the acceptance among general surgeons remains unknown. The aim of our study was to gauge the degree of agreement with the guidelines among health care professionals worldwide.MethodsForty-six key statements and recommendations of the International guidelines for groin hernia management were selected and presented at plenary consensus conferences at four international congresses in Europe, the America’s and Asia. Participants could cast their votes through live voting. Additionally, a web survey was sent out to all society members allowing online voting after each congress. Consensus was defined as > 70% agreement among all participants.ResultsIn total 822 surgeons cast their vote on the key statements and recommendations during the four plenary consensus meetings or via the web survey. Consensus was reached on 34 out of 39 (87%) recommendations, and on six out of seven (86%) statements. No consensus was reached on the use of light versus heavy-weight meshes (69%), superior cost-effectiveness of day-case laparo-endoscopic repair (69%), omitting prophylactic antibiotics in hernia repair, general or local versus regional anesthesia in elderly patients (55%) and re-operation in case of immediate postoperative pain (59%).ConclusionGlobally, there is 87% consensus regarding the diagnosis and management of groin hernias. This provides a solid basis for standardizing the care path of patients with groin hernias.
Journal Article