Robotic gastrectomy using hinotori™ Surgical Robot System: Initial case series.

BACKGROUND: This study aims to prove the feasibility and safety of robotic gastrectomy using the hinotori™ Surgical Robot System (Medicaroid Corporation, Kobe, Japan). METHODS: We retrospectively enrolled the 16 patients who underwent gastrectomy by the hinotori™ Surgical Robot System for gastric cancer at our hospital between June 2023 and January 2024. Console surgeons performed almost all lymphadenectomies, including the clipping of vessels. Assistant surgeons supported the lymphadenectomy using vessel sealing devices and during reconstruction. RESULTS: Thirteen patients were cStage I, one patient was cStage II, and two patients were cStage III. Distal gastrectomy, proximal gastrectomy, and total gastrectomy were performed in 11, 1, and 4 patients, respectively. D1+ and D2 lymphadenectomies were performed in 11 and 5 patients, respectively. Billroth-I, Billroth-II, Roux-en-Y, and esophagogastrostomy were performed in three, six, six, and one patients, respectively. The median operation time was 282 (245-338) min, and the median console time was 226 (185-266) min. The median blood loss was 28 (12-50) mL, and the median amylase levels in drainage fluid were 280 (148-377) U/L on postoperative day 1 and 74 (42-148) U/L on postoperative day 3. There was anastomotic leakage (Clavien-Dindo [CD] IIIa) in one patient who underwent proximal gastrectomy. The median postoperative hospital stay was 12.5 (12-14) days. CONCLUSION: In this initial case series, the hinotori™ Surgical Robot System was found to be safe and feasible for patients with gastric cancer and is suggested to be appropriate for gastrectomy, including distal gastrectomy and total gastrectomy.

Feasibility of implementing a remote system for lymphoedema conservative therapy: a case study.

BACKGROUND: Poor access to lymphoedema specialists and communication between them and patients prevents appropriate lymphoedema management. Therefore, development and dissemination of remote systems is necessary to improve care in rural areas with limited medical personnel or access to medical coordination. AIMS: The authors evaluated the elements required for providing patient education on conservative therapy for lymphoedema, to determine the feasibility of remote management. METHODS: The study involved connecting a health professional in a local clinic (point A) treating a patient with lymphoedema, who was present alongside the clinician, with a specialist certified lymphoedema therapist (CLT) located remotely in a university (point B). FINDINGS: The CLT was able to greet, interview and provide guidance to the patient on conservative therapy. Direct contact with the patient was not possible, which limited visualisation, palpation, leg circumference measurement, and lymphatic drainage management. CONCLUSION: The findings suggest that remote a lymphoedema management approach involving conservative therapy benefits both patients and health professionals, particularly in rural regions. Future studies are needed to confirm the effectiveness of this approach to confirm adequate treatment.

Self-Sampling by Adolescents at Home: Assessment of the Feasibility to Successfully Collect Blood Microsamples by Inexperienced Individuals.

Blood microsampling has increasingly attracted interest in the past decades as a more patient-centric sampling approach, offering the possibility to collect a minimal volume of blood following a finger or arm prick at home. In addition to conventional dried blood spots (DBS), many different devices allowing self-sampling of blood have become available. Obviously, the success of home-sampling can only be assured when (inexperienced) users collect samples of good quality. Therefore, the feasibility of six different microsampling devices to collect capillary blood by inexperienced adolescents at home was evaluated. Participants (n = 95) were randomly assigned to collect blood (dried or liquid) at different time points using four of six different self-sampling devices (i.e., DBS, Mitra volumetric absorptive microsampling (VAMS), Capitainer B, Tasso M20, Minicollect tube and Tasso+ serum separator tube (SST)). The quality of the samples was visually inspected and analytically determined. Moreover, the participants' satisfaction was assessed via questionnaires. Although a majority succeeded based on the visual inspection, the success rate differed largely between the different devices. In general, the lowest success rate was obtained for the Minicollect tubes, although there is an opportunity and need for improvement for the other self-sampling devices as well. Hence, this also emphasizes the importance to assess the quality of samples collected by the target population prior to study initiation. In addition, visual classification by a trained individual was confirmed based on assessment of the analytical variability between replicates. Finally, self-sampling at home was overall (very) positively received by the participants.

Cerina: cognitive-behavioural therapy-based mobile application for managing GAD symptoms among Ulster University Students in Northern Ireland - a protocol for a pilot feasibility randomised controlled trial.

INTRODUCTION: University students are one of the most vulnerable populations for anxiety disorders worldwide. In Northern Ireland, anxiety disorders appear to be more common among the university student population due to the population demographics across the region. Despite the need, these students show less inclination to access the widely available on-campus well-being services and other external professional services. Digital cognitive-behavioural therapy (CBT) aims to bridge this gap between the need for psychological help and access to it. However, challenges such as limited reach, low adoption, implementation barriers and poor long-term maintenance are mainstay issues resulting in reduced uptake of digital CBT. As a result, the potential impact of digital CBT is currently restricted. The proposed intervention 'Cerina' is a scalable CBT-based mobile app with an interactive user interface that can be implemented in university settings if found to be feasible and effective. METHODS AND ANALYSIS: The study is a single-blind pilot feasibility randomised controlled trial aiming to test the feasibility and preliminary effects of Cerina in reducing Generalised Anxiety Disorder (GAD) symptoms. Participants are 90 Ulster University students aged 18 and above with self-reported GAD symptoms. They will be allocated to two conditions: treatment (ie, access to Cerina for 6 weeks) and a wait-list control group (ie, optional on-campus well-being services for 6 weeks). Participants in the wait-list will access Cerina 6 weeks after their randomisation and participants in both conditions will be assessed at baseline, at 3 (mid-assessment) and 6 weeks (postassessment). The primary outcome is the feasibility of Cerina (ie, adherence to the intervention, its usability and the potential to deliver a full trial in the future). The secondary outcomes include generalised anxiety, depression, worry and quality of life. Additionally, participants in both conditions will be invited to semistructured interviews for process evaluation. ETHICS AND DISSEMINATION: Ethical approval for the study has been granted by the Ulster University Research Ethics Committee (ID: FCPSY-22-084). The results of the study will be disseminated through publications in scientific articles and presentations at relevant conferences and/or public events. TRIAL REGISTRATION NUMBER: NCT06146530.

Acceptability and feasibility of a theatre-based wellness programme to support people living with long COVID: a single-arm feasibility study.

OBJECTIVES: To determine acceptability and feasibility of a theatre-based wellness programme to support the health and well-being of people with long COVID. DESIGN: Single-group, repeated-measures feasibility study. SETTING: Community centre and online. PARTICIPANTS: Adults with diagnosed long COVID experiencing breathlessness, pain and/or loneliness. INTERVENTION: Six-week participatory creative programme delivered to one online and one in-person group facilitated by movement, voice and drama consultants using breathing, visualisation, singing, poetry, storytelling and movement exercises. PRIMARY OUTCOME MEASURES: Programme acceptability and feasibility measured via uptake, reasons for non-attendance and barriers to engagement. SECONDARY OUTCOME MEASURES: Feasibility of recruitment and data collection procedures measured through proportion of missing data and follow-up rates, mechanisms of action of the programme identified through qualitative interviews, changes in mental health, well-being, quality of life, loneliness, social support, fatigue, breathlessness and post-COVID-19 functional status at 8-week follow-up. RESULTS: 21 people expressed interest in participating, 20 people took part in the programme, 19 completed baseline and 16 completed follow-up assessments. Participants attended an average of 4.8 of 6 sessions (SD=1.5, range 2-6). Exploratory analyses demonstrated significant improvements in self-rated health (t-test mean difference=0.12, 95% CI=0.00, 0.23, p=0.04) and chronic fatigue symptoms (mean difference=-3.50, 95% CI=-6.97, -0.03, p=0.05) at 8 weeks. Key mechanisms of action that supported health and well-being included: increased sense of community, illness acceptance, experiencing joy, increased confidence in managing everyday life, increased ability to relax and reconnection with previous identity. Barriers to engagement included: activities being outside of the participant's comfort zone, ongoing long COVID symptoms, emotional consequences of sharing experiences and connectivity and connecting online. CONCLUSIONS: A 6-week theatre-based programme was perceived as acceptable to most participants and resulted in some positive psychosocial impacts. The findings provide a rationale for supporting the ongoing development and scale-up of this and related arts programmes to support people living with long COVID.

Digital Physical Activity and Exercise Interventions for People Living with Chronic Kidney Disease: A Systematic Review of Health Outcomes and Feasibility.

Physical activity is essential to interrupt the cycle of deconditioning associated with chronic kidney disease (CKD). However, access to targeted physical activity interventions remain under-supported due to limited funding and specialised staff. Digital interventions may address some of these factors. This systematic review sought to examine the evidence base of digital interventions focused on promoting physical activity or exercise and their effect on health outcomes for people living with CKD. Electronic databases (PubMed, CINAHL, Embase, Cochrane) were searched from 1 January 2000 to 1 December 2023. Interventions (smartphone applications, activity trackers, websites) for adults with CKD (any stage, including transplant) which promoted physical activity or exercise were included. Study quality was assessed, and a narrative synthesis was conducted. Of the 4057 records identified, eight studies (five randomised controlled trials, three single-arm studies) were included, comprising 550 participants. Duration ranged from 12-weeks to 1-year. The findings indicated acceptability and feasibility were high, with small cohort numbers and high risk of bias. There were inconsistent measures of physical activity levels, self-efficacy, body composition, physical function, and psychological outcomes which resulted in no apparent effects of digital interventions on these domains. Data were insufficient for meta-analysis. The evidence for digital interventions to promote physical activity and exercise for people living with CKD is limited. Despite popularity, there is little evidence that current digital interventions yield the effects expected from traditional face-to-face interventions. However, 14 registered trials were identified which may strengthen the evidence-base.

Determining the optimal frequency of SARS-CoV-2 regular asymptomatic testing: A randomized feasibility trial in a home care setting.

BACKGROUND: The SARS-CoV-2 pandemic presented a challenge for caregiving relatives in the home care setting. Caregivers can transmit SARS-CoV-2 to their relatives who are often at high risk for a severe course of COVID-19. Regular testing of asymptomatic caregivers for SARS-CoV-2 may reduce the risk of transmission. The optimal method and frequency of regular asymptomatic testing is unknown. We conducted a prospective, randomised trial to assess the feasibility, recruitment and acceptance of different testing frequencies. This serves to inform a future definitive randomised controlled trial. METHODS: We carried out a parallel three-armed feasibility trial, enrolling adult participants who provided home-based care for a relative at least twice a week. Participants were randomly assigned using sealed envelopes to either conduct saliva-based antigen self-testing at a frequency of once a week (group I), twice a week (group II), or every two days (group III). The participants completed questionnaires on a weekly basis. Main outcome measures were feasibility of recruitment, adherence to self-tests and distress caused by self-testing. We further collected data on the use of mouth-nose mask. RESULTS: From 25 March to 7 May 2021 we assessed 27 participants and randomised 26 in the study: 8 participants in group I, 8 in group II and 10 in group III. All participants completed the study. In group I 48/48 (100.0%; 95% CI 92.6% to 100.0%), in group II 93/96 (96.9%; 95% CI 91.2% to 98.9%) and in group III 209/210 (99.5%; 95% CI 97.4% to 99.9%) self-tests were carried out at home. Participants did not perceive regular self-testing as burdensome in any of the study arms. We did not observe any infection with SARS-CoV-2. During the study, mask adherence decreased from 35% to 19% in all groups. CONCLUSION: Conducting such a study was feasible. The participants tolerated regular self-testing well, which was reflected in a high level of test adherence. However, regular self-testing may have led to decreased protective behaviour. To demonstrate that regular asymptomatic testing reduces infection transmission, a future definitive trial should be performed at a time of a high prevalence of SARS-CoV-2 and be implemented as a multicentre study. TRIAL REGISTRATION: The trial is registered with the German Clinical Trials Register, DRKS00026234.

Multispectral label-free in vivo cellular imaging of human retinal pigment epithelium using adaptive optics fluorescence lifetime ophthalmoscopy improves feasibility for low emission analysis and increases sensitivity for detecting changes with age and eccentricity.

Significance: Adaptive optics fluorescence lifetime ophthalmoscopy (AOFLIO) provides a label-free approach to observe functional and molecular changes at cellular scale in vivo. Adding multispectral capabilities improves interpretation of lifetime fluctuations due to individual fluorophores in the retinal pigment epithelium (RPE). Aim: To quantify the cellular-scale changes in autofluorescence with age and eccentricity due to variations in lipofuscin, melanin, and melanolipofuscin in RPE using multispectral AOFLIO. Approach: AOFLIO was performed on six subjects at seven eccentricities. Four imaging channels ( λ ex / λ em ) were used: 473/SSC, 473/LSC, 532/LSC, and 765/NIR. Cells were segmented and the timing signals of each pixel in a cell were combined into a single histogram, which were then used to compute the lifetime and phasor parameters. An ANOVA was performed to investigate eccentricity and spectral effects on each parameter. Results: A repeatability analysis revealed < 11.8 % change in lifetime parameters in repeat visits for 532/LSC. The 765/NIR and 532/LSC had eccentricity and age effects similar to previous reports. The 473/LSC had a change in eccentricity with mean lifetime and a phasor component. Both the 473/LSC and 473/SSC had changes in eccentricity in the short lifetime component and its relative contribution. The 473/SSC had no trend in eccentricity in phasor. The comparison across the four channels showed differences in lifetime and phasor parameters. Conclusions: Multispectral AOFLIO can provide a more comprehensive picture of changes with age and eccentricity. These results indicate that cell segmentation has the potential to allow investigations in low-photon scenarios such as in older or diseased subjects with the co-capture of an NIR channel (such as 765/NIR) with the desired spectral channel. This work represents the first multispectral, cellular-scale fluorescence lifetime comparison in vivo in the human RPE and may be a useful method for tracking diseases.

The feasibility of delivering cardiac brief intervention to patients following ST-elevation myocardial infarction: Protocol for a pilot randomised controlled trial.

BACKGROUND: Patients experience emotional distress and hold cardiac misconceptions following ST-elevation myocardial infarction. These issues informed the co-production of Cardiac Brief Intervention with patients and clinicians. The current study will establish a knowledge base for the feasibility of delivering this intervention to patients following ST-elevation myocardial infarction, with a preliminary exploration of impact on associated outcomes (ClinicalTrials.gov: NCT05848674). METHODS: A pilot randomised controlled trial incorporating a mixed-methods design will be conducted. Patients with ST-elevation myocardial infarction (number = 40) will be recruited from coronary care units at two hospital centres in Northern Ireland, with participants randomised (1:1) to the intervention or control group. Cardiac Brief Intervention constitutes a nurse-led, short (20 minutes) emotional and educational support discussion with a patient, with a leaflet that serves as a memory-aid. It will be delivered to the intervention group prior to discharge from a coronary care unit. The control group will receive standard care information. Data will be collected at baseline, post-intervention, 4 weeks from diagnosis, and 14 weeks from diagnosis. Feasibility measurements and process evaluation (quantitative and qualitative) will assess the viability of the research design and intervention delivery. Cardiac rehabilitation attendance data will be collected, and participants will complete questionnaires related to associated outcomes. Quantitative data will be reported with descriptive statistics and qualitative data will be analysed using framework analysis, with data integrated to achieve triangulation of findings. DISCUSSION: Educational and emotional difficulties following ST-elevation myocardial infarction may impede patient outcomes and cardiac rehabilitation participation. These issues informed the co-production of Cardiac Brief Intervention with patients and clinicians. This study will evaluate the feasibility of delivering Cardiac Brief Intervention to patients. These results will inform large-scale definitive testing of the intervention, which may lead to adoption in clinical practice to improve cardiac rehabilitation uptake and patient outcomes.

HAP-FAST: a feasibility study incorporating qualitative, mechanistic and costing sub-studies alongside a randomised pilot trial comparing chest x-ray to low-dose CT scan and empirical antibiotics to antibiotics guided by the BIOFIRE® FILM ARRAY® pneumonia plus panel in adults with suspected non-ventilator-associated hospital-cquired pneumonia.

INTRODUCTION: Non-ventilator-associated hospital-acquired pneumonia (nv-HAP) is the most common healthcare-associated infection (HCAI), is associated with high mortality and morbidity and places a major burden on healthcare systems. Diagnosis currently relies on chest x-rays to confirm pneumonia and sputum cultures to determine the microbiological cause. This approach leads to over-diagnosis of pneumonia, rarely identifies a causative pathogen and perpetuates unnecessary and imprecise antibiotic use. The HAP-FAST study aims to evaluate the feasibility of a randomised trial to evaluate the clinical impact of low-dose, non-contrast-enhanced thoracic CT scans and rapid molecular sputum analysis using the BIOFIRE® FILMARRAY® pneumonia plus panel (FAPP) for patients suspected with nv-HAP. METHODS AND ANALYSIS: The HAP-FAST feasibility study consists of a pilot randomised trial, a qualitative study, a costing analysis and exploratory analyses of clinical samples to investigate the immune-pathophysiology of HAP. Participants are identified and recruited from four acute hospitals in the Northwest of the UK. Using a Research Without Prior Consent model, the pilot trial will recruit 220 adult participants, with or without mental capacity, and with suspected HAP. HAP-FAST is a non-blinded, sequential, multiple assignment, randomised trial with two possible stages of randomisation: first, chest x-ray (CXR) or CT; second, if treated as nv-HAP, FAPP or standard microbiological processing alone (no FAPP). Pathogen-specific antibiotic guidance will be provided for FAPP results. Randomisation uses a web-based platform and followed up for 90 days. The feasibility of a future trial will be determined by assessing trial processes, outcome measures and patient and staff experiences. ETHICS AND DISSEMINATION: This study has undergone combined review by the UK NHS Research Ethics Committee and Health Research Authority. Results will be disseminated via peer-reviewed journals, via the funders' website and through a range of media to engage the public. TRIAL REGISTRATION NUMBER: NCT05483309.

Assessment of the information provided by ChatGPT regarding exercise for patients with type 2 diabetes: a pilot study.

OBJECTIVES: We assessed the feasibility of ChatGPT for patients with type 2 diabetes seeking information about exercise. METHODS: In this pilot study, two physicians with expertise in diabetes care and rehabilitative treatment in Republic of Korea discussed and determined the 14 most asked questions on exercise for managing type 2 diabetes by patients in clinical practice. Each question was inputted into ChatGPT (V.4.0), and the answers from ChatGPT were assessed. The Likert scale was calculated for each category of validity (1-4), safety (1-4) and utility (1-4) based on position statements of the American Diabetes Association and American College of Sports Medicine. RESULTS: Regarding validity, 4 of 14 ChatGPT (28.6%) responses were scored as 3, indicating accurate but incomplete information. The other 10 responses (71.4%) were scored as 4, indicating complete accuracy with complete information. Safety and utility scored 4 (no danger and completely useful) for all 14 ChatGPT responses. CONCLUSION: ChatGPT can be used as supplementary educational material for diabetic exercise. However, users should be aware that ChatGPT may provide incomplete answers to some questions on exercise for type 2 diabetes.

Intravenous ketamine for emergency department treatment of suicidal ideation in a paediatric population: protocol for a double-blind, randomised, placebo-controlled, parallel-arm pilot trial (KSI study).

INTRODUCTION: Suicidal ideation (SI) is a common and severe cause of morbidity in adolescents. Patients frequently present to the emergency department (ED) for care, yet there is no acute therapeutic intervention for SI. A single dose of intravenous ketamine has demonstrated efficacy in rapidly reducing SI in adults; however, ketamine has not been studied in paediatrics. We aim to determine the feasibility of a trial of a single intravenous ketamine dose to reduce SI for patients in the paediatric ED. METHODS AND ANALYSIS: This will be a single-centre, double-blind, randomised, placebo-controlled, parallel-arm pilot trial of intravenous ketamine for ED treatment of SI in a paediatric population. INTERVENTION: one intravenous dose of 0.5 mg/kg of ketamine (max 50 mg), over 40 min. Placebo: one intravenous dose of 0.5 mL/kg (max 50 mL) of normal saline, over 40 min. Participants will be randomised in a 1:1 ratio. SI severity will be measured at baseline, 40 min, 80 min, 120 min, 24 hours and 7 days. We aim to recruit 20 participants. The primary feasibility outcome is the proportion of eligible patients who complete the study protocol. We will pilot three SI severity tools and explore the efficacy, safety and tolerability of the intervention. ETHICS AND DISSEMINATION: This study will be conducted according to Canadian Biomedical Research Tutorial, international standards of Good Clinical Practice and the Health Canada, Food and Drug Act, Part C, Division 5. The study documents have been approved by the CHEO Research Institute Research Ethics Board (CHEO REB (23/02E)). Participants must provide free and informed consent to participate. If incapable due to age, assenting participants with parental/legal guardian consent may participate. On completion, we will endeavour to present results at international conferences, and publish the results in a peer-reviewed journal. Participants will receive a results letter. TRIAL REGISTRATION NUMBER: NCT05468840.

Mentalisation-based online intervention for psychologically distressed parents: protocol of a non-randomised feasibility trial of the Lighthouse Parenting Programme-Online (LPP-Online).

INTRODUCTION: Online-based interventions provide a low-threshold way to reach and support families. The mentalisation-based Lighthouse Parenting Programme is an established intervention aimed at preventing psychopathological development in children. The objective of this study is to examine the feasibility of an online adaptation of the Lighthouse Parenting Programme (LPP-Online), evaluating (a) recruitment capability, compliance, acceptability and satisfaction with the intervention; (b) the psychometric properties of and the acceptability regarding the adjunct psychological evaluation; and (c) the employed materials and resources. The study will also obtain a preliminary evaluation of participants' responses to the intervention. METHOD AND ANALYSIS: In this monocentric, one-arm, non-randomised feasibility trial, n=30 psychologically distressed parents with children aged 0 to 14 years will participate in the LPP-Online for a duration of 8 weeks. The intervention consists of online group sessions and individual sessions, 38 smartphone-based ecological momentary interventions (EMI), and psychoeducational materials (website, booklet). At baseline (T0) and the end of the intervention (T1), parents complete self-report questionnaires as well as 7-day ecological momentary assessments (EMA) via smartphone. During the intervention, additional EMA are completed before and after the daily EMI. An interview regarding parents' subjective experience with the intervention will be conducted at T1. The feasibility of the intervention, the psychological evaluation and the resources will be examined using descriptive and qualitative analyses. The preliminary evaluation of the parents' response to the intervention will be conducted by analysing pre-post changes in questionnaire measures and the 7-day EMA as well as data of additional EMA completed before and after the daily EMI. ETHICS AND DISSEMINATION: Ethical approval of the study has been obtained from the local ethics board (Faculty of Behavioural and Cultural Studies, University of Heidelberg). Consent to participate will be obtained before starting the assessments. Results will be disseminated as publications in peer-reviewed scientific journals and at international conferences. REGISTRATION DETAILS: German Clinical Trials Register (DRKS00027423), OSF (https://doi.org/10.17605/OSF.IO/942YW).

Participants' perspectives of being recruited into a randomised trial of a weight loss intervention before colorectal cancer surgery: a qualitative interview study.

BACKGROUND: The period between cancer diagnosis and surgery presents an opportunity for trials to assess the feasibility of behaviour change interventions. However, this can be a worrying time for patients and may hinder recruitment. We describe the perspectives of patients with excess weight awaiting colorectal cancer surgery about their recruitment into a randomised trial of a prehabilitation weight loss intervention. METHODS: We interviewed the first 26 participants from the 8 recruitment sites across England in the 'CARE' feasibility trial. Participants were randomised into either usual care (n = 13) or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian (n = 13). The semi-structured interviews occurred shortly after recruitment and the questions focused on participants' recollections of being recruited into the trial. We analysed data rapidly and then used a mind-mapping technique to develop descriptive themes. Themes were agreed by all co-authors, including a person with lived-experience of colorectal surgery. RESULTS: Participants had a mean body mass index (± SD) of 38 kg/m2 (± 6), age of 50 years (± 12), and 42% were female. People who participated in the trial were motivated by the offer of structured weight loss support that could potentially help them improve their surgical outcomes. However, participants also had concerns around the potential unpalatability of the intervention diet and side effects. Positive attitudes of clinicians towards the trial facilitated recruitment but participants were disappointed when they were randomised to usual care due to clinical teams' overemphasis on the benefits of losing weight. CONCLUSIONS: Patients were motivated to take part by the prospect of improved surgical outcomes. However, the strong preference to be allocated to the intervention suggests that balanced communication of equipoise is crucial to minimise disappointment from randomisation to usual care and differential dropout from the trial. CLINICAL TRIAL REGISTRATION: ISRCTN39207707, Registration date 13/03/2023.

Clinical efficacy and safety of transvaginal natural orifice transluminal endoscopic surgery for benign adnexal disease: a prospective trial.

BACKGROUND: There is a scarcity of prospective clinical research evidence regarding the utilization of transvaginal natural orifice translumenal endoscopic surgery (vNOTES) as a treatment option for ovarian cysts. The objective of this study was to assess the feasibility and safety of employing vNOTES for the management of ovarian cysts. METHODS: Our study included women between the ages of 18 and 70 who intended to undergo surgical intervention for benign lesions. Stratified blocked randomization was employed to allocate participants into groups. The main objective was to assess whether the assigned group adhered to the recommended surgical technique for ovarian cystectomy or adnexectomy, without any deviation to alternative surgical methods. RESULTS: A total of 196 patients were included in the study, with all surgeries in each group being conducted according to the assigned procedures. Among them, the ovarian cystectomy layer included 58 cases in the vNOTES group and 58 cases in the conventional laparoscopy (CL) groups. The adnexectomy layer included 40 cases in the vNOTES group and 40 cases in the CL group. Utilizing a sensitivity analysis, the two-sided 95% lower confidence limit was determined to be 5.5% for the disparity in proportions between the vNOTES groups and CL groups. These lower limits fell below the predetermined non-inferiority margin of 10%. CONCLUSIONS: The study findings demonstrate that vNOTES was not inferior to CL in terms of adnexectomy or ovarian cystectomy. vNOTES can be considered a more minimally invasive surgical approach, as it results in reduced postoperative pain, faster recovery, and absence of visible incisions. Overall, vNOTES proves to be a safe, feasible, and less invasive treatment option. TRIAL REGISTRATION: This study retrospectively registered with the China Clinical Trial Registry with the registration number ChiCTR2100052223(22-10-2021).

Clinical study on freehand of bicortical sacral screw fixation with the assistance of torque measurement device.

BACKGROUND: Sacral screw loosening is a typical complication after internal fixation surgery through the vertebral arch system. Bicortical fixation can successfully prevent screw loosening, and how improving the rate of bicortical fixation is a challenging clinical investigation. OBJECTIVE: To investigate the feasibility of improving the double corticality of sacral screws and the optimal fixation depth to achieve double cortical fixation by combining the torque measurement method with bare hands. METHODS: Ninety-seven cases of posterior lumbar internal fixation with pedicle root system were included in this study. Based on the tactile feedback of the surgeon indicating the expected penetration of the screw into the contralateral cortex of the sacrum, the screws were further rotated by 180°, 360°, or 720°, categorized into the bicortical 180° group, bicortical 360° group, and bicortical 720° group, respectively. Intraoperatively, the torque during screw insertion was recorded. Postoperatively, the rate of double-cortex engagement was evaluated at 7 days, and screw loosening was assessed at 1 year follow-up. RESULTS: The bicortical rates of the 180° group, 360° group, and 720° group were 66.13%, 91.18% and 93.75%, respectively. There were statistically significant differences between the 180° group and both the 360° and 720° groups (P < 0.05). However, there was no statistically significant difference between the 360° group and the 720° group (P > 0.05).The rates of loosening of sacral screws in the 180° group, 360° group, and 720° group were 20.97%, 7.35% and 7.81%, respectively. There were statistically significant differences between the 180° group and both the 360° and 720° groups (P < 0.05). However, there was no statistically significant difference between the 360° group and the 720° group (P > 0.05). The bicortical 360° group achieved a relatively satisfactory rate of dual cortical purchase while maintaining a lower rate of screw loosening. CONCLUSION: Manual insertion of sacral screws with the assistance of a torque measurement device can achieve a relatively satisfactory dual cortical purchase rate while reducing patient hospitalization costs.

Examining the feasibility and utility of heart rate variability on intervention outcomes targeting emotion regulation in autism: a brief report.

Autistic youth experience several behavioral and emotional characteristics that can predispose them to emotion dysregulation (ED). Current literature examining ED in autism spectrum disorder (ASD) is limited to parent- and self-reported measures, indicating a need for biological or physiological methods to better assess emotion regulation in ASD. Utilizing the autonomic nervous system, specifically heart rate variability (HRV), may be a promising method to objectively measure ED in ASD, given it is one of the body's primary means of regulating physiological arousal. Our pilot study is one of the first to examine the feasibility, utility, and construct validity of HRV along with clinical measures within an intervention targeting ED-specific symptoms in ASD. Participants included 30 autistic youth ages 8-17 years who participated in the pilot study of Regulating Together, a group-based intervention targeting emotion regulation. We demonstrate HRV is feasible, demonstrates adequate test-retest reliability, and is complimentary to clinician- and parent-reported measures. Our preliminary findings also point to certain HRV profiles being indicative of long-term outcomes after receiving treatment. HRV may be a useful, objective tool in determining differential needs of long-term follow-up care for treatment maintenance at screening or baseline stages.

Applying the multiphase optimization strategy to evaluate the feasibility and effectiveness of an online road safety education intervention for children and parents: a pilot study.

BACKGROUND: Reports of children's engagement in active transportation outline low participation rates in many countries despite many associated mental, physical, and social health benefits. One of the main contributors to this phenomenon is a cited lack of education and knowledge among children regarding active travel (AT), specifically road safety. To address this issue, the aim of this study was to evaluate the feasibility and effectiveness of an online road safety education intervention to promote AT among children and their parents. METHODS: Applying the Multiphase Optimization Strategy (MOST) for intervention development, implementation, and evaluation, we designed and assessed a four-module online road safety education intervention with a sample of 57 parent-child dyads using a 23 factorial design featuring both qualitative and quantitative analyses. RESULTS: Main intervention feasibility findings include positive and critical feedback on the program's content and design, and moderate participant engagement as reflected by program retention and completion rates. With respect to the preliminary intervention effectiveness on children, a significant improvement in road safety knowledge scores was observed for groups that feature the "wheeling safety and skills" module. Slight improvements in AT knowledge scores across all the intervention groups were observed, but were not of significance. Preliminary intervention effectiveness on select parental AT practices and perceptions saw significant improvements in some groups. Groups that featured the 'wheeling safety and skills' module exhibited significantly higher guided choice scores upon completion of the program than those who did not receive this component. CONCLUSION: The MOST framework allowed us to design and evaluate the feasibility and preliminary effectiveness of an online road safety education intervention. The developed intervention has demonstrated that it has the potential to improve children's road safety knowledge and some areas of parental AT practices and perceptions, to which improvements may be attributed to the inclusion of the "wheeling safety and skills" module, suggesting that the targeted focus on cycling skills is a prioritized area. AT programming and practice implications are discussed. Future research is encouraged to refine modules to better reflect the priorities of children and parents and to test these refined components among larger samples. WORD COUNT: 9,391 (excludes abstract, tables, figures, abbreviations, and references).

Three-dimensional exergaming conjunction with vestibular rehabilitation in individuals with Benign Paroxysmal Positional Vertigo: A feasibility randomized controlled study.

BACKGROUND: To examine the effectiveness of 3D (dimensional)-vestibular rehabilitation therapy (VRT) on gait, balance problems, processing time speed and subjective complaints in patients with Benign Paroxysmal Positional Vertigo (BPPV) compared to a control group (CG). This study aimed to test the feasibility of virtual reality-based 3D exergaming conjunction with vestibular rehabilitation. METHODS: Twenty-two patients with BPPV (negative DixHallpike/Roll test results, existing dizziness/balance complaints) were randomly allocated to the study group (SG, n:11 3D-VRT) or Control group (CG n:11, no exercise-rehabilitation) for 8 week. The SG performed 3D-VRT for 45 to 50 min/d, 3 times/wk, and the CG did receive only Canalith Repositioning Maneuver (CRM). CRM was applied in both groups before the study. Outcome measures included 10-Meter-Walk-Test (10-MWT) (with/without head turns), Dynamic Gait Index (DGI), Choice-Stepping-Reaction-Time-ped (CSRT-MAT), Fullerton Advanced Balance Scale (FAB), and Visual Analog Scale (VAS). RESULTS: The SG showed significantly improvement in 10-MWT without (p5 = 0.00,η2 = 0.49), with horizontal (p5 = 0.00,η2 = 0.57),vertical (p5 = 0.01,η2 = 0.48) head turns, DGI (p5 = 0.00,η2 = 0.74), CSRT-MAT, FAB (p5 = 0.00,η2 = 0.78) and VAS-dizziness (p5 = 0.00,η2 = 0.65), VAS-balance problem (p5 = 0.00,η2 = 0.43), VAS-fear of falling (p5 = 0.00,η2 = 0.42) compared to the CG. CONCLUSION: The 3D-VRT were effective in improving gait, balance, processing speed and resolving the subjective complaints in BPPV. The 3D-VRT method is feasible for patients who suffer from residual dizziness or balance complaints after CRM. Furthermore, the 3D-VRT is more accessible and less expensive than other virtual reality applications, which may facilitate further research or clinical use.

Retrospective study on the feasibility and safety of laparoscopic surgery for complicated fistulizing diverticular disease in a high-volume colorectal center.

BACKGROUND: We assessed feasibility and safety of laparoscopic sigmoidectomy for complicated fistulizing diverticular disease in a tertiary care colorectal center. METHODS: A single-center retrospective study of patients undergoing sigmoidectomy for fistulizing diverticular disease between 2011 and 2021 was realized. Primary outcomes were rates of conversion to open surgery and severe postoperative morbidity at 30 days. Secondary outcomes included rates of postoperative bladder leaks on cystogram. RESULTS: Among the 104 patients, 32.7% had previous laparotomy. Laparoscopy was the initial approach in 103 (99.0%), with 6 (5.8%) conversions to laparotomy. Clavien-Dindo grade ≥ III complication rate at 30 days was 10.6%, including two (1.9%) anastomotic leaks. The median postoperative length of stay was 4.0 days. Seven (6.7%) patients underwent reoperation, six (5.8%) were readmitted, and one (0.9%) died within 30 days. Twelve (11.5%) ileostomies were created initially, and two (1.9%) were created following anastomotic leaks. At last follow-up, 101 (97.1%) patients were stoma-free. Urgent surgeries had a higher rate of severe postoperative complications. Among colovesical fistula patients (n = 73), postoperative cystograms were performed in 56.2%, identifying two out of the three bladder leaks detected on closed suction drains. No differences in postoperative outcomes occurred between groups with and without postoperative cystograms, including Foley catheter removal within seven days (73.2% vs. 90.6%, p = 0.08). CONCLUSIONS: Laparoscopic surgery for complicated fistulizing diverticulitis showed low rates of severe complications, conversions to open surgery and permanent stomas in high-volume colorectal center.