Surgical margins are crucial in determining postoperative local recurrence (LR) in patients with colorectal liver metastasis (CRLM) and hepatocellular carcinoma (HCC). Achieving a margin greater than 1 cm can be challenging due to constraints related to remnant liver reserve, proximity to major vascular structures and tumour depth. We previously published findings from a retrospective study suggesting that additional margin coagulation (AMC) using radiofrequency may reduce LR, and this multicentre randomised clinical trial aims to further assess this hypothesis.
The LIVERATION trial is an international, multicentre, single-blind, randomised, parallel-group, controlled clinical trial involving 698 patients undergoing liver resection for CRLM or HCC. Participants will be randomly assigned in a 1:1 ratio to either AMC (study group) or conventional liver resection (control group) to assess oncological outcomes for both CRLM and HCC. The primary outcome is the incidence of LR. Secondary endpoints include overall survival, disease-free survival, cancer-specific survival, surgical complications and quality of life. Follow-ups occur at 30 days, 90 days, and 1, 2 and 3 years postoperatively.
The LIVERATION trial has been approved by the Ethics Committee at the sponsor site Hospital del Mar de Barcelona, CEIM-PSMAR (Comité de Ética de la Investigación con Medicamentos – Parc de Salut Mar), as well as by the Institutional Ethics Committees in all participating countries. The results of the main trial, along with each of the secondary endpoints, will be submitted for publication in a peer-reviewed journal. The study adheres to national and international guidelines, including the Declaration of Helsinki, and complies with regulations for studies involving biological samples under Law 14/2007 on Biomedical Research. A dissemination strategy has been developed to engage stakeholders and facilitate knowledge transfer to support the use of the findings of the study. LIVERATION is funded by the European Union under the Horizon Europe Framework Programme (Project Number: 101104360).
To assess the effects of behaviourally informed short message service (SMS) reminders on demand for human papillomavirus (HPV) immunisation.
Individually randomised, five-group, controlled parallel trial.
A country-wide trial in Georgia.
55 176 girls aged 10–12, the entire population of unvaccinated girls of this age in the country, for whom there existed caregiver contact details.
Girls were randomised into five arms (four with n=11 035, with one n=11 036). Caregivers of the girls in four of the arms (treatment groups) were sent different versions of an SMS reminder (SMSR), reminding them that the girl was due to receive the HPV vaccine. The control group was sent no SMSR.
The primary outcome was a girl’s HPV vaccination status at the end of the trial.
Girls and their caregivers were blinded to group assignment.
The number of participants analysed in the four treatment groups was 10,784, 10,802, 10,794 and 10,820, with 10 828 analysed in the control group.
Each of the SMSRs was more effective than the control (no reminder) in encouraging HPV vaccination. Girls whose caregiver(s) were sent version 3 had 65% greater odds of receiving the vaccine relative to the control group (OR=1.65; 95% CI 1.38 to 1.97). Among girls whose caregivers received version 1, version 2 and version 4 of the SMS, the odds of receiving the HPV vaccine were respectively 42% (OR=1.42; 95% CI 1.18 to 1.70), 34% (OR=1.34; 95% CI 1.12 to 1.61) and 35% (OR=1.35; 95% CI 1.13 to 1.62) higher compared with the girls in the control arm.
We find a positive and statistically significant effect for each version of the SMSR, relative to the control condition.
Occiput posterior position is the most common fetal malposition, complicating up to 35% of initial labours, and its persistence can lead to increased risks of adverse maternal and perinatal outcomes. The role of maternal postures, such as lateral recumbent and hands-and-knees, in promoting the anterior rotation of the fetal head has been investigated in several randomised trials in the last two decades, with mostly negative results. However, both methodological and study design limitations may have contributed to such findings. Recently, the use of forward-leaning inversion and side-lying release procedures and of the Rebozo technique has been implemented into clinical practice as a non-invasive alternative to promote the anterior rotation of the fetal head. Yet, neither intervention has been rigorously assessed in a controlled study. Our aim is to conduct a randomised controlled trial to assess whether a combination of forward-leaning inversion and side-lying release procedures and the Rebozo technique in a pre-specified sequence during the first stage of labour of women with a posterior fetus would favour its anterior rotation.
The ReMaP-POPP (Rebozo and maternal procedures to prevent persistent occiput posterior position of the fetal head) trial will be an open-label single-centre randomised controlled trial with two parallel groups. Women will be eligible if they are ≥18 years old, in labour (3 to 8 cm) and with a singleton term fetus (≥370/7 weeks) in an occiput posterior position confirmed by transabdominal sonography. Eligible women will be randomised into two groups: (1) intervention, a sequence of forward-leaning inversion and side-lying release procedures and Rebozo technique (duration 90–105 min); and (2) control, standard of care (maternal postures, including upright, lateral recumbent and hands-and-knees). Blinding will be guaranteed only for the physician assessing the fetal head position by sonography. Randomisation will be performed using randomly permuted blocks of varying sizes (4, 6 and 8), stratified by parity, in a 1:1 ratio. The primary outcome will be the probability of occiput posterior position of the fetal head 3 hours and 30 min after randomisation, diagnosed by sonography. Secondary outcomes will include the probability of occiput posterior position at full cervical dilation and at birth, maternal and neonatal health-related outcomes, as well as maternal pain intensity and ability to cope with pain and birth satisfaction level. We will also assess safety outcomes regarding challenges in adequate fetal heart rate monitoring during the time interval between randomisation and primary outcome assessment. Sample size estimation considered the possibility to decrease the probability of occiput posterior position from 35.8% (control, based on prior retrospective data at our Institution) to 22% with the proposed intervention. With a power of 0.90 and a two-sided value of 0.05, the estimated sample size will be n=462 (n=231/arm). Considering a potential attrition rate of 20%, n=578 women will be needed. Enrolment will require approximately 16 months. Primary and secondary outcomes will be analysed on an intention-to-treat basis. The effects of the intervention will be estimated by relative risks and their 95% CI.
The study has been approved by the Lombardy Ethics Committee n.3 (n. 5499, 20 December 2024). Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time. Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of midwifery and obstetrics. Also, they will be disseminated to the public through outreach activities involving families and healthcare specialists.
The study has been registered in the Clinical Trials database (NCT06887634).
Central venous catheters (CVCs) are commonly used in intensive care but should be removed as soon as they are no longer needed to reduce infection risk. Peripheral venous access then becomes necessary, but can be challenging due to oedema. Near-infrared light devices, simple non-invasive tools, may assist nurses in this procedure. We hypothesise that a near-infrared light device (AccuVein AV500) could improve the first-attempt success rate of peripheral venous catheter (PVC) placement in intensive care patients no longer requiring a central catheter.
This investigator-initiated, prospective, multicentre, randomised controlled superiority trial compares the near-infrared light device to the landmark approach for PVC insertion in critically ill patients with an existing CVC. A total of three hundred and eighty patients are to be randomised in two parallel groups with a stratification on centre and anticipated difficulty of peripheral venous access.
The study objective is to compare the first-attempt success rate of PVC placement in adult critical care patients for whom a central catheter is no longer indicated.
The protocol and amendments have been approved by the French ethics committee (Comité de Protection des Personnes Sud Ouest et Outre Mer II, Toulouse, France, number 2023-A00429-36), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals.
Clinicaltrials.gov: NCT06234293.
Parkinson’s disease (PD) is a neurodegenerative, progressive disorder known for motor and non-motor symptoms. The vestibular system, via the vestibulo-ocular reflex (VOR), is crucial for maintaining dynamic gaze stability, and its role in PD is raising interest among researchers. Indeed, vestibular dysfunction in PD may exacerbate postural instability and gait disturbances; however, the prevalence of vestibular dysfunctions remains unclear. This study aims to objectively investigate the VOR function in people with PD using the video head impulse test.
This is a cross-sectional study conducted in a neurorehabilitation hospital. People with PD were included if they had no cognitive impairment and the ability to walk without physical assistance. The video head impulse test was used to assess the VOR function across all six semicircular canals, using both the Head Impulse Paradigm (HIMP) and the Suppression Head Impulse Paradigm (SHIMP) paradigms.
35 people with PD (mean age: 69.9±8.4; 11 females) with moderate motor symptoms (MDS-UPDRS-part III: 27.7±6.8) were included. Using normative cut-offs, 69% of the participants had at least one dysfunctional canal (60% hypo-gain, 9% hyper-gain). The prevalence reached 83% when both the HIMP and SHIMP paradigms were considered.
There is a high prevalence of vestibular dysfunction in people with PD. The instrumental assessment of VOR gains could reveal undiagnosed vestibular dysfunctions and, in the future, lead to more specific rehabilitation management of people with PD.
Healthcare settings are experiencing profound changes that make them increasingly complex and demanding environments, particularly for nurses. Against this backdrop are the numerous phenomena of violence in healthcare settings, which are a worrying reflection of the growing problem of aggression in society. Institutions maintain a constant focus on the phenomenon while trying to counter it; however, workplace aggression is still on the rise.
Workplace violence (WPV) potentially leads to lower quality of care and increased costs; it also exposes nurses to burnout, turnover and intention to leave the profession.
The purpose of this scoping review is to explore the physical and psychological consequences on nurses who are victims of WPV and to identify possible correlations with burnout, turnover and intention to leave the workforce.
This scoping review will follow the methodology proposed by Arksey and O’Malley, also incorporating recommendations from the Joanna Briggs Institute Handbook for Scoping Review. A literature search will be conducted in PubMed, CINAHL, PsycInfo, Web of Science and Scopus. Grey literature sources including Google Scholar and ProQuest Dissertations & Theses will also be consulted. Data will be summarised in descriptive form and categorised according to the identified outcome variables, following an inductive approach. The results will be presented following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
The review will include studies published from January 2020 to March 2025.
This scoping review represents the preliminary phase of a larger project aimed at developing support strategies for nurses who are victims of violence.
This scoping review protocol has been registered in the Open Science Framework (https://osf.io/785qd/?view_only=21952c15efd14b34a9931f07121bf935). No ethical opinion is required, as the review does not involve direct involvement of human subjects.
The findings will be disseminated through peer-reviewed publications and presentations at national and international conferences and workshops dedicated to workplace safety and nursing. In addition, the results will be shared with healthcare managers and stakeholders to inform context-specific strategies and support interventions within care settings.
El auge de las terapias complementarias y las diversas y contradictorias manifestaciones con respecto a sus efectos justifican la necesidad de evaluar su efectividad para así regular la seguridad de su utilización. Para la valoración crítica del artículo se ha utilizado la herramienta propuesta por el “National Heart, Lung, and Blood Institute” para estudios experimentales prepost sin grupo control. [fragmento del texto]