ABSTRACT
INTRODUCTION: Patients with end-stage liver disease awaiting orthotopic liver transplantation (OLT) are generally classified as frail due to disease-related malnutrition and a progressive decline in musculoskeletal and aerobic fitness, which is associated with poor pre-OLT, peri-OLT and post-OLT outcomes. However, frailty in these patients may be reversable with adequate exercise and nutritional interventions. METHODS AND ANALYSIS: Non-randomised clinical trial evaluating the effect of a home-based bimodal lifestyle programme in unfit patients with a preoperative oxygen uptake (VO2) at the ventilatory anaerobic threshold ≤13 mL/kg/min and/or VO2 at peak exercise ≤18 mL/kg/min listed for OLT at the University Medical Center Groningen (UMCG). The programme is patient tailored and comprises high-intensity interval and endurance training, and functional exercises three times per week, combined with nutritional support. Patients will go through two training periods, each lasting 6 weeks.The primary outcome of this study is the impact of the programme on patients' aerobic fitness after the first study period. Secondary outcomes include aerobic capacity after the second study period, changes in sarcopenia, anthropometry, functional mobility, perceived quality of life and fatigue, incidence of hepatic encephalopathy and microbiome composition. Moreover, number and reasons of intercurrent hospitalisations during the study and postoperative outcomes up to 12 months post OLT will be recorded. Finally, feasibility of the programme will be assessed by monitoring the participation rate and reasons for non-participation, number and severity of adverse events, and dropout rate and reasons for dropout. ETHICS AND DISSEMINATION: This study was approved by the Medical Research Ethics Committee of the UMCG (registration number NL83612.042.23, August 2023) and is registered in the Clinicaltrials.gov register (NCT05853484). Good Clinical Practice guidelines and the principles of the Declaration of Helsinki will be applied. Results of this study will be submitted for presentation at (inter)national congresses and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05853484.
Subject(s)
End Stage Liver Disease , Liver Transplantation , Aged , Humans , End Stage Liver Disease/complications , End Stage Liver Disease/surgery , Exercise Therapy/methods , Frail Elderly , Life Style , Quality of Life , Clinical Trials as TopicABSTRACT
Objectives Correct sizing of endoprostheses used for the treatment of abdominal aortic aneurysms is important to prevent endoleaks and migration. Sizing requires several steps and each step introduces a possible sizing error. The goal of this study was to investigate the magnitude of these errors compared to the golden standard: a vessel phantom. This study focuses on the errors in sizing with three different brands of computed tomography angiography scanners in combination with three reconstruction software packages. Methods Three phantoms with a different diameter, altitude and azimuth were scanned with three computed tomography scanners: Toshiba Aquilion 64-slice, Philips Brilliance iCT 256-slice and Siemens Somatom Sensation 64-slice. The phantom diameters were determined in the stretched view after central lumen line reconstruction by three observers using Simbionix PROcedure Rehearsal Studio, 3mensio and TeraRecon planning software. The observers, all novices in sizing endoprostheses using planning software, measured 108 slices each. Two senior vascular surgeons set the tolerated error margin of sizing on ±1.0 mm. Results In total, 11.3% of the measurements (73/648) were outside the set margins of ±1.0 mm from the phantom diameter, with significant differences between the scanner types (14.8%, 12.1%, 6.9% for the Siemens scanner, Philips scanner and Toshiba scanner, respectively, p-value = 0.032), but not between the software packages (8.3%, 11.1%, 14.4%, p-value = 0.141) or the observers (10.6%, 9.7%, 13.4%, p-value = 0.448). Conclusions It can be concluded that the errors in sizing were independent of the used software packages, but the phantoms scanned with Siemens scanner were significantly more measured incorrectly than the phantoms scanned with the Toshiba scanner. Consequently, awareness on the type of computed tomography scanner and computed tomography scanner setting is necessary, especially in complex abdominal aortic aneurysms sizing for fenestrated or branched endovascular aneurysm repair if appropriate the sizing is of upmost importance.
