ABSTRACT
Background: Haemorrhoidal disease (HD) is a very common anorectal disorder and recurrence rates are high. Currently, there is no consensus regarding the best treatment option in recurrent HD, due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. Objectives and research questions: To compare the effectiveness and cost-effectiveness of repeat RBL versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent grade II and III HD. Method(s): The Napoleon Trial originated as a randomized controlled trial (RCT), comparing three generally accepted HD interventions. However, the trial was launched during the COVID-19 pandemic, when proctological care was strongly diminished or even cancelled. Furthermore, many HD patients expressed a treatment preference, and did therefore did not want to be randomized. Hence, inclusion of patients was greatly hampered. As a possible way forward, the study design of the RCT could be substituted by a comprehensive cohort study (CCS). A CCS consists of a randomization cohort (RC) and an observational cohort (OC). Patients without a treatment preference are randomly assigned to one of the three interventions (RC) and patients with a treatment preference receive their preferred therapy (OC). The objective of the CCS remains the same as in the RCT, as does the patient population, in-and exclusion criteria, and primary and secondary outcomes. All patients are followed up and contribute to data collection. Data are combinedly analysed using statistical methods comparable to meta-analyses. The total sample size needs to be increased from 558 to 650 patients, consisting of 216 patients in the RC and 434 patients in the OC.
ABSTRACT
Background: Extracorporeal life support (ECLS) is increasingly used worldwide over the past two decades and new indications are emerging, including extracorporeal cardiopulmonary resuscitation, trauma and COVID-19 cases. A frequent and remained feared complication is bleeding, and it is associated with high morbidity and mortality. However, trends of bleeding complications and outcomes have been poorly investigated. Methods: Veno-venous (V-V) and veno-arterial (V-A) ECLS patients from the Extracorporeal Life Support Organization (ELSO) Registry database between 2000 and 2020 were included. Bleeding complication and mortality trends were analyzed. Bleeding complications included surgical site, cannulation site, gastrointestinal, pulmonary central nervous system and tamponade bleeding. Risk factors for bleeding complications were identified with multivariable analysis. Results: The analysis included 50.444 patients with single ECLS runs, 30.696 patients with V-A ECLS and 19.748 with V-V ECLS. Bleeding complications were reported in 13.534 patients (26.8%) and occurred more often in V-A ECLS compared to V-V ECLS patients (30.0% versus 21.9%). Bleeding patients showed lower hospital survival rates in both groups. Over the past twenty years bleeding complications showed a decreasing trend with a coefficient of -1.124 and -1.661 for V-V and V-A ECLS respectively. Surgical and cannulation site bleeding showed highest negative trend in both ECLS groups. Conclusions: The decrease in bleeding complications, especially cannulation and surgical site related bleeding, over the past two decades suggest improvement in anticoagulation management and possible equipment development. However, the persistent high rates of bleeding complications and association with mortality reinforces the need to understand bleeding complications more thoroughly during ECLS.
ABSTRACT
OBJECTIVE: To systematically collect clinical data from patients with a proven COVID-19 infection in the Netherlands. DESIGN: Data from 2579 patients with COVID-19 admitted to 10 Dutch centers in the period February to July 2020 are described. The clinical data are based on the WHO COVID case record form (CRF) and supplemented with patient characteristics of which recently an association disease severity has been reported. METHODS: Survival analyses were performed as primary statistical analysis. These Kaplan-Meier curves for time to (early) death (3 weeks) have been determined for pre-morbid patient characteristics and clinical, radiological and laboratory data at hospital admission. RESULTS: Total in-hospital mortality after 3 weeks was 22.2% (95% CI: 20.7% - 23.9%), hospital mortality within 21 days was significantly higher for elderly patients (> 70 years;35, 0% (95% CI: 32.4% - 37.8%) and patients who died during the 21 days and were admitted to the intensive care (36.5% (95% CI: 32.1% - 41.3%)). Apart from that, in this Dutch population we also see a risk of early death in patients with co-morbidities (such as chronic neurological, nephrological and cardiac disorders and hypertension), and in patients with more home medication and / or with increased urea and creatinine levels. CONCLUSION: Early death due to a COVID-19 infection in the Netherlands appears to be associated with demographic variables (e.g. age), comorbidity (e.g. cardiovascular disease) but also disease char-acteristics at admission.