Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial.

BACKGROUND: One of the most severe complications in laparoscopic cholecystectomy (LC) is intraoperative bile duct injury (BDI). Despite its low incidence, the medical implications for the patient can be serious. Besides, BDI can also generate significant legal issues in healthcare. Different techniques have been described to reduce the incidence of this complication, and near-infrared fluorescence cholangiography with indocyanine green (NIRFC-ICG) is one of the latest additions. In spite of the great interest aroused by this procedure, there are currently great disparities in the usage or administration protocols of ICG. METHODS AND ANALYSIS: This is a randomised, multicentre, per-protocol analysis, open clinical trial with four arms. The estimated duration of the trial is 12 months. The aim of the study is to analyse whether there are differences between the dose and administration ICG intervals to obtain good-quality NIRFC during LC. The primary outcome is the degree of identification of critical biliary structures during LC. In addition, different factors will be analysed that may have an influence on the results of this technique. ETHICS AND DISSEMINATION: The trial will be conducted according to the recommendations for Clinical Trials in the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects and the recommendations of the Spanish Agency of Medicines and Medical Devices (AEMPs) for clinical trials. This trial was approved by the local institutional Ethics Committee and the AEMPs. The results of the study will be presented to the scientific community through publications, conferences or other means. EUDRACT NUMBER: 2022-000904-36. PROTOCOL VERSION: V.1.4, 2 June 2022 TRIAL REGISTRATION NUMBER: NCT05419947.

A 6-mRNA host response classifier in whole blood predicts outcomes in COVID-19 and other acute viral infections.

Predicting the severity of COVID-19 remains an unmet medical need. Our objective was to develop a blood-based host-gene-expression classifier for the severity of viral infections and validate it in independent data, including COVID-19. We developed a logistic regression-based classifier for the severity of viral infections and validated it in multiple viral infection settings including COVID-19. We used training data (N = 705) from 21 retrospective transcriptomic clinical studies of influenza and other viral illnesses looking at a preselected panel of host immune response messenger RNAs. We selected 6 host RNAs and trained logistic regression classifier with a cross-validation area under curve of 0.90 for predicting 30-day mortality in viral illnesses. Next, in 1417 samples across 21 independent retrospective cohorts the locked 6-RNA classifier had an area under curve of 0.94 for discriminating patients with severe vs. non-severe infection. Next, in independent cohorts of prospectively (N = 97) and retrospectively (N = 100) enrolled patients with confirmed COVID-19, the classifier had an area under curve of 0.89 and 0.87, respectively, for identifying patients with severe respiratory failure or 30-day mortality. Finally, we developed a loop-mediated isothermal gene expression assay for the 6-messenger-RNA panel to facilitate implementation as a rapid assay. With further study, the classifier could assist in the risk assessment of COVID-19 and other acute viral infections patients to determine severity and level of care, thereby improving patient management and reducing healthcare burden.

Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain.

OBJECTIVE: The purpose of this study was to investigate the presence of active myofascial trigger points (MTrPs) in a greater number of muscles than previous studies and the relation between the presence of MTrPs, the intensity of pain, disability, and sleep quality in mechanical neck pain. METHODS: Fifteen patients with mechanical neck pain (80% women) and 12 comparable controls participated. Myofascial trigger points were bilaterally explored in the upper trapezius, splenius capitis, semispinalis capitis, sternocleidomastoid, levator scapulae, and scalene muscles in a blinded design. Myofascial trigger points were considered active if the subject recognized the elicited referred pain as a familiar symptom. Myofascial trigger points were considered latent if the elicited referred pain was not recognized as a symptom. Pain was collected with a numerical pain rate scale (0-10); disability was assessed with Neck Disability Index; and sleep quality, with the Pittsburgh Sleep Quality Index. RESULTS: Patients exhibited a greater disability and worse sleep quality than controls (P < .001). The Pittsburgh Sleep Quality Index score was associated with the worst intensity of pain (r = 0.589; P = .021) and disability (r = 0.552; P = .033). Patients showed a greater (P = .002) number of active MTrPs (mean, 2 ± 2) and similar number (P = .505) of latent MTrPs (1.6 ± 1.4) than controls (latent MTrPs, 1.3 ± 1.4). No significant association between the number of latent or active MTrPs and pain, disability, or sleep quality was found. CONCLUSIONS: The referred pain elicited by active MTrPs in the neck and shoulder muscles contributed to symptoms in mechanical neck pain. Patients exhibited higher disability and worse sleep quality than controls. Sleep quality was associated with pain intensity and disability. No association between active MTrPs and the intensity of pain, disability, or sleep quality was found.

Is intravenous iron useful for reducing transfusions in surgically treated colorectal cancer patients?

BACKGROUND: The goal of the present study was to determine whether the intravenous administration of iron in the postoperative period of colon cancer surgical patients suffices to reduce the number of transfusions necessary. METHOD: The study was designed as a retrospective observational study conducted over a three-year period. A paired case-control design was used to analyze the effect of postoperative iron on patients' blood transfusion needs. Two groups were established (the case group, which received postoperative iron and the control group, which did not) and matched for age (± 3 years), gender, type of operation, tumor stage, and surgical approach. Of 342 patients who underwent operation, 104 paired patients were obtained for inclusion in this study (52 in each group). A second analysis was made to assess the effect of intravenous iron on the evolution of hemoglobin between the first postoperative day and hospital discharge in the subgroup of patients with reduction in hemoglobin, in subjects without preoperative or postoperative transfusions. Finally, a total of 71 patients were paired in two groups: 37 and 31 patients in case and control, respectively. RESULTS: The mean hemoglobin concentration at discharge for the case group was 10 ± 1.1 g/dl, vs. 10.6 ± 1.2 in the controls (P = 0.012). The number of transfusions in the case group was 3 ± 1.6, vs. 3.3 ± 3 in the control group (P = 0.682). Thus, 28.8 % of the patients in the case group received transfusions, versus 30.8 % of those in the control group (P = 0.830). In the second analysis, the decrease in hemoglobin concentration was 0.88 g/dl and 0.82 g/dl in case and control, respectively. CONCLUSIONS: Intravenous iron does not appear to reduce the blood transfusion requirements in the postoperative period of colorectal surgery patients with anemia. We consider that further studies are needed to more clearly define the usefulness of intravenous iron in reducing the transfusion needs in such patients.