Smoking is associated with an approach bias toward smoking-related stimuli. Approach bias modification (ApBM), a computerized training specifically designed to modify this approach bias, has shown positive effects in patients with alcohol use disorder; however, its efficacy as an add-on in smoking cessation treatment is inconclusive. The aim of this clinical trial was to investigate whether ApBM as an add-on to smoking cessation treatment results in higher 6-month prolonged abstinence rates compared to two control conditions. In this randomized, controlled, double-blind, single-center superiority trial, 351 participants received a 1-day cognitive-behavioral smoking cessation treatment (treatment as usual [TAU]) and were subsequently randomized to either TAU+ApBM (N=119), TAU+sham training (N=115), or TAU only (N=117). Training sessions were conducted over 7 days. The primary outcome was prolonged abstinence at 6-month follow-up. Participants were classified as either nonsmoking (continuous abstinence for 6 months, ≤5 cigarettes since quit attempt, and breath CO level ≤9 ppm) or relapsed (no objective verification of smoking status, breath CO level ≥10 ppm, >5 cigarettes since quit attempt). In the intention-to-treat analyses, abstinence rates at 6 months were 19.3% (95% CI=12.13, 26.53) for TAU+ApBM, 17.4% (95% CI=10.36, 24.42) for TAU+sham training, and 16.2% (95% CI=9.46, 23.02) for TAU only, with no significant differences between groups. This large-scale clinical trial demonstrates that TAU+ApBM is not significantly superior to TAU+sham training or TAU only. ApBM has been included in Australian and German alcohol use disorder treatment guidelines, but this randomized controlled trial shows that positive effects do not apply to tobacco use disorder.

Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial.

To evaluate cabergoline's efficacy at decreasing lactation symptoms after early second-trimester abortion or pregnancy loss. This is a multisite, double-blind, gestational-age stratified superiority trial that compared cabergoline 1 mg once with placebo for preventing bothersome breast symptoms immediately after uterine evacuation. We enrolled pregnant people at 16-20 weeks of gestation who were English- or Spanish-speaking and without contraindication to the study drug. Participants received cabergoline within 4 hours of uterine evacuation or fetal expulsion and, at baseline and at multiple time points through 2 weeks postprocedure, completed a validated electronic survey that assessed breast symptoms, side effects, and bother. Our primary outcome was breast symptoms (a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4; we planned to enroll 30 participants in each gestational duration strata to show a 40% difference in breast symptoms (80% power, α=0.049). After screening 145 patients from February 2024 through May 2025, we enrolled 69 eligible participants. Baseline demographics were balanced between groups: Median gestational duration was 18 weeks (range 16 0/7-19 6/7 weeks), 53.0% were nulliparous, 63.6% self-identified as Hispanic, and 68.2% had public insurance. On day 4, significantly fewer participants who received cabergoline reported any breast symptoms compared with placebo (50.0% vs 88.2%, P<.001) (primary outcome) and fewer participants reported significant bother from breast symptoms (3.1% vs 20.6%, P=.05) (secondary outcome). These differences persist even in the earlier gestational duration strata. Cabergoline is an effective and well-tolerated medication to prevent breast symptoms after early second-trimester abortion or pregnancy loss. ClinicalTrials.gov: NCT06029673.

Accurate arterial pressure monitoring is critical in cardiac surgery to guide haemodynamic management and vasopressor therapy. Radial arterial pressure monitoring may systematically underestimate central aortic pressure compared with femoral monitoring, potentially leading to inappropriate vasopressor escalation and associated complications. Recent evidence demonstrates that excessive norepinephrine exposure is associated with acute kidney injury and increased mortality in cardiac surgery patients. To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients. This is a prospective, randomised, controlled, single-blind, superiority trial conducted at two French university hospitals (CHU Besançon and CHU Dijon). Adult patients undergoing cardiac surgery with cardiopulmonary bypass will be randomised 1:1 to receive either femoral or radial arterial pressure monitoring. The primary endpoint is the proportion of patients treated with norepinephrine from anaesthetic induction to postoperative day 7. Secondary endpoints include acute kidney injury according to KDIGO criteria, cardiac complications, vasoactive-inotropic scores, duration of vasopressor therapy, vascular complications, and 7-day and 30-day mortality. Sample size calculation indicates 340 patients (170 per group) are needed to detect a 15% absolute reduction in norepinephrine use with 90% power and α=0.05, and an anticipated loss to follow-up rate of 5%. The study has been approved by the French Ethics Committee (Comité de Protection des Personnes Nord-Ouest II, no. 2024/897) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in peer-reviewed journals and presented at international conferences. NCT06952907.

Laparoscopic hiatal hernia (HH) repair is associated with a high recurrence rate. Repair reinforced with mesh lowers short-term recurrence but can cause dysphagia and visceral erosion. Results of the PRIME trial, in which non-absorbable mesh reinforcement of the posterior crural repair was investigated, showed equal recurrence compared with primary suture repair after 6 months. This study investigates the use of circular absorbable mesh reinforcement in primary HH repair. Prospective double-blinded randomised controlled superiority trial comparing two laparoscopic procedures for HH repair (110 vs 110). Adult patients with proven HH Skinner types II-IV (defined by preoperative CT scan) are included. Patients are randomised to undergo a laparoscopic primary crural repair with sutures alone or suture repair augmented with biosynthetic absorbable, circular mesh at the hiatus. Radiologic integrity of the hiatal repair 1 year after surgery is the main endpoint. Secondary objectives are clinical recurrence of the hernia, development of postoperative reflux disease, postoperative side effects and satisfaction with surgical outcome. Outcome assessors are blinded to allocation. Data are collected at baseline, and follow-up includes interviews and digital questionnaires at 3, 12, 24, 36, 48 and 60 months, as well as CT scan at 12 and 60 months. All patients randomised will be analysed according to the intention-to-treat principle. Ethics approval has been obtained by the local ethics committee at Isala, Zwolle, the Netherlands (Medical Ethics Review Committee (METc) Isala, study number: 190516). METc Isala is no longer active; all duties have been taken over by METc of the University Medical Center Groningen. The trial's results will be submitted to a peer-reviewed international journal as well as (inter)national conferences. Registered in the Dutch national trial registry: OMON (NL-OMON48062).

Immune checkpoint inhibitors (ICIs) achieve sufficient receptor occupancy at much lower than standard approved doses. We hypothesized that ultra-low-dose nivolumab would retain clinical efficacy. In this phase III randomized superiority trial, patients with advanced solid tumors (Eastern Cooperative Oncology Group 0-1) and progression on ≥1 prior line of systemic therapy were randomly assigned 1:1 to ultra-low-dose nivolumab (20 mg intravenously once every 2 weeks) or standard chemotherapy (docetaxel or paclitaxel, as per tumor type). Treatment continued until progression or intolerable toxicity. The primary end point was overall survival (OS). From June 2020 to February 2024, we enrolled 500 patients: 250 per arm; 52% had head and neck and 36% lung cancers. The median number of prior lines of therapy was 1 (range, 1-8); 29% had received ≥2 prior lines. Median OS was significantly longer with ultra-low-dose nivolumab: 5.88 months (95% CI, 4.99 to 7.13) versus 4.70 months (95% CI, 3.91 to 5.65; hazard ratio [HR], 0.80 [95% CI, 0.66 to 0.97]; P = .022). One-year OS was 27.3% versus 16.9%. Median progression-free survival was similar: 2.04 months (95% CI, 2.00 to 2.10) with ultra-low-dose nivolumab and 2.09 months (95% CI, 2.04 to 2.17) with chemotherapy (HR, 1.03 [95% CI, 0.86 to 1.23]; P = .77). Grade ≥3 treatment-related adverse events were less frequent with ultra-low-dose nivolumab (42.5% v 60.8%; P < .001). Quality of life (QoL) was significantly better with ultra-low-dose nivolumab. Ultra-low-dose nivolumab significantly improves OS versus chemotherapy in pretreated solid tumors, with fewer severe toxicities and better QoL. These findings support re-evaluation of ICI dosing strategies and may enhance global access.

Background Less than 10% of pregnant women in Sub Saharan Africa achieve the World Health Organization recommended eight antenatal care (ANC) contacts for optimal pregnancy management. Robust strategies that involve community outreach programmes, integrated service delivery and continuity of care could help improve ANC uptake and quality. Kenya, as other countries, has promoted use of digital health records at the community and facility levels to improve quality and access to data and promote continuity of care. These records, however, are not always linked and access to data does not guarantee its use to drive quality improvement. C-it-DU-it (pronounced “See it, Do it”) is a two-arm pragmatic cluster-randomised trial set in Homabay County, Kenya. The trial will implement digital linkage of community and facility electronic patient data (control arm) and assess the impact of having quality improvement teams reviewing and acting on the linked data (intervention arm). While several areas are captured in the community health records, we will focus on uptake of ANC services as a lens. Methods Eighteen healthcare facilities (clusters) will be randomly allocated to either the control or intervention arms at a ratio of 1:1. A data linkage module will be deployed in all clusters, enabling digital referral of pregnant women between the community and health facilities. In each intervention cluster, work improvement teams will be established and trained on reviewing these electronic ANC data, identifying problems, developing and deploying context-specific solutions to these problems and evaluating the impact of their interventions. ANC data will be extracted for 1,440 recruited pregnant women. The primary outcome will be the proportion of pregnant women with at least eight ANC contacts. Secondary outcomes will be ANC uptake before 16 weeks gestation, adverse pregnancy outcomes, uptake of required investigations, medication and skilled birth attendance. Discussion This trial intends to generate evidence on the benefit of community work improvement teams to review and act on linked digital data to develop and deploy solutions to local problems. This strategy, if successful, will promote antenatal service uptake and quality resulting in improved pregnancy outcomes and progress towards sustainable development goals if appropriately scaled up. Clinical Trial Registration : https://clinicaltrials.gov/study/NCT05929586 , identifier NCT05929586.

AimsAdolescent idiopathic scoliosis affects 0.2% to 0.5% of adolescents, often requiring bracing to reduce the risk of curve progression. While bracing is typically discontinued at skeletal maturity, significant curve progression can occur afterwards, potentially necessitating surgery. The Bracing AdoleScent Idiopathic Scoliosis (BASIS) 2 study, nested within the larger BASIS trial, aims to evaluate the efficacy of prolonged full-time and night-time bracing beyond skeletal maturity in reducing curve progression. The aim is to determine if six months of additional bracing at normal prescription, after skeletal maturity, significantly reduces curve progression and is acceptable to patients with adolescent idiopathic scoliosis who were successfully treated with bracing.MethodsThis multicentre, prospective, parallel group, pragmatic, open-label, randomized controlled superiority trial will recruit participants from the BASIS study who reach skeletal maturity with a curve < 50°. Participants will be randomized 1:1 to either continue bracing for six months or cease bracing immediately.OutcomesThe primary outcome is curve progression from baseline to two years post-skeletal maturity. Secondary outcomes include radiological measures, patient bracing experience and any preferences, and cost-effectiveness. The sample size is estimated at 228 participants. Results will be disseminated through peer-reviewed publications, conference presentations, and to study participants.Cite this article: Bone Jt Open 2026;7(1):130–137.

Body dissatisfaction is highly prevalent in Latin America, including Colombia. However, culturally adapted, evidence-based interventions are lacking, although effective programs exist in Western countries. This protocol describes a cluster randomized controlled trial (cRCT) of an intervention to improve media literacy and decrease body dissatisfaction and related outcomes among adolescents in urban and rural schools in Colombia. We will recruit 1250 adolescents in 7th-10th grade (aged 11-17years) to participate in a two-arm, cluster-randomized, open-label, controlled superiority trial in Colombia. Participating schools will be recruited by the research team. Participants will be randomized at the school level (1:1). Randomization blocks stratified by socioeconomic status (high vs. low) and geographical area (rural vs. urban) will be used to assign schools to either: (a) a school-based, four-session group intervention delivered over 2-4weeks by trained facilitators (n = 625) or (b) a waitlist control group that will receive the intervention only after follow-up (n = 625). Participants need to be aged 11-17years old, attending a participating school and class in grades 7 to 10, have written parental consent, and give written assent to be eligible for participation in this study. Individuals who cannot understand spoken or written language, or who do not have parental consent to participate, will be excluded. Primary outcomes are media literacy and body dissatisfaction. Secondary outcomes include appearance comparison, thin ideal internalization, curvy ideal internalization (girls only), drive for muscularity (boys only), eating disorder symptoms, and general wellbeing. Additional exploratory outcomes include risky appearance-altering behaviours (girls only), colourism, and skin colour satisfaction. Furthermore, adverse outcomes will be recorded. Outcome assessments will happen pre-intervention (baseline; Timepoint 1), 1-week post-intervention (immediate post-test; Timepoint 2), and 9-12months post-intervention (follow-up; Timepoint 3). Based on pilot data, we hypothesise that the intervention group will demonstrate increased media literacy and decreased body dissatisfaction at post-test and follow-up. We also anticipate improvements in secondary outcomes. This will be the first cluster RCT to evaluate the effect of a culturally adapted body image intervention in Colombia. This trial has been registered in the ISRCTN Registry (ISRCTN15802562, https://doi.org/10.1186/ISRCTN15802562). First enrolment was on 26th of August 2025. This trial has been registered in the ISRCTN Registry (ISRCTN15802562, https://doi.org/10.1186/ISRCTN15802562).

This trial compared single-procedure efficacy and safety of pulsed field ablation (PFA) vs radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal atrial fibrillation (AF). BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites. Eligible patients (aged 18-80 years) with symptomatic, drug-resistant paroxysmal AF were randomized (1:1) to either PFA (pentaspline) or RFA following the CLOSE protocol (contact force sensing catheter and electro-anatomical mapping system). The primary endpoint was the single-procedure success rate after 12 months defined as the absence of ≥30 s atrial arrhythmia recurrence, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation. From December 2021 to January 2024, 292 patients were randomized and 289 (median age 63.5 years, 58% male) were analysed (PFA n = 145, RFA n = 144). Single-procedure success at 12 months was 112/145 (77.2%) in the PFA group and 111/143 (77.6%) in the RFA group (adjusted difference 0.9%; 95% confidence interval -8.2% to 10.1%; P = .84). Procedure-related serious adverse events occurred in 5 (3.4%) PFA vs 11 (7.6%) RFA patients (difference -3.3% [-8.4%, 1.8%]). No deaths, persistent phrenic palsy nor stroke occurred. In the RFA group, two patients had pulmonary vein stenosis >70% and 12 > 50%, two tamponades, and one oesophageal bleed. This randomized trial performed in patients with paroxysmal AF did not demonstrate superior efficacy of single-shot PFA vs point-by-point RFA using the CLOSE protocol regarding single-procedure freedom from atrial arrhythmias, despite fewer safety events being observed in this study with PFA.

BackgroundCatheter-related or central line-associated bloodstream infection (CRBSI/CLABSI) causes substantial morbidity and mortality. Managing CRBSI/CLABSI often involves removing the infected central venous catheter (CVC) and inserting a new one at a different vascular site. Currently, no adjunct antimicrobial lock therapy (in combination with systemic antibiotics) has been FDA-approved and is urgently needed. Our study evaluated a novel triple combination antimicrobial therapy (Mino Lok (MLT)) containing minocycline, EDTA, and ethanol. MLT has shown broad-spectrum in-vitro activity and positive results in a Phase 2 trial.MethodsThis international, multicenter, superiority trial was conducted at 34 sites. Cancer, hemodialysis (HD), or other patients requiring a long-term CVC (LTCVC), aged ≥ 12 years, with CLABSI/CRBSI, were enrolled and randomized in a 1:1 ratio to receive either MLT or site-specific standard of care (SOC) antimicrobial lock for 2 hours/day for 7 days. The primary endpoint was median time to catheter failure (defined as mortality, catheter removal due to inability to administer lock or infectious-related reasons, worsening signs/symptoms, persistent or recurrent bloodstream infection, or deep-seated infection).ResultsFrom February 2018 to February 2024, 241 subjects were enrolled and randomized with 228 receiving study drug. A significant difference in median time to catheter failure in intent-to-treat (ITT) and modified ITT (MITT) populations (p≤ 0.0006) was observed (Figures 1 & 2). The CVC was successfully retained in 57% of patients in MLT vs 38% in SOC (p=0.0025). Clinical and microbiological failure related to the catheter or CLABSI were significantly higher in SOC (p=0.0058 and p=0.012, respectively) (Table 1). Adverse events (AEs), serious AEs (SAEs) and all-cause mortality were comparable for the two groups. There were no drug-related SAEs.ConclusionThis phase 3 pivotal study demonstrated MLT to be highly effective and superior to SOC antimicrobial locks in salvaging LTCVCs associated with CRBSI/CLABSI in cancer, HD and other patients requiring LTCVC. MLT has broad-spectrum activity, was well-tolerated, and was not associated with drug-related SAEs. MLT may satisfy an urgent unmet need in the management of CRBSIs/CLABSI.DisclosuresAnne-Marie Chaftari, MD, Citius Pharmaceuticals, Inc., Cranford, New Jersey, USA: Grant/Research Support Vinay Rathore, MD, Citius Pharmaceuticals, Inc. 11 Commerce Drive, First Floor Cranford: Grant/Research Support Paul P. Cook, MD, Gilead: Grant/Research Support|Janssen: Grant/Research Support|Pfizer: Grant/Research Support Onix Cantres-Fonseca, MD, Citius Pharmaceuticals, Inc.: Grant/Research Support Mayur Ramesh, MD, Citius Pharmaceuticals, Inc.: Grant/Research Support Mark E. Rupp, MD, Armata: Advisor/Consultant|Citius Pharmaceuticals, Inc.: Advisor/Consultant|Magnolia: Grant/Research Support|Teleflex: Advisor/Consultant Leonard Mermel, DO, Citius Pharma: Advisor/Consultant|CorMedix Pharma: Advisor/Consultant|Destiny Pharma: Board Member|Lightline Medical: Advisor/Consultant|Pristine Access Technology: Advisor/Consultant|Pristine Access Technology: Stocks/Bonds (Private Company) Alan Lader, PhD, Citius Pharmaceuticals, Inc.: Senior Vice-President/employee Issam I. Raad, Distinguished Professor, Citius Pharmaceuticals, Inc. (Grant/Research Support): Advisor/Consultant|Citius Pharmaceuticals, Inc. (Grant/Research Support): Grant/Research Support|Citius Pharmaceuticals, Inc. (Grant/Research Support): Patent|Citius Pharmaceuticals, Inc. (Grant/Research Support): Ownership Interest|Citius Pharmaceuticals, Inc. (Grant/Research Support): Stocks/Bonds (Public Company)|Spectrum Vascular: Patent|Spectrum Vascular: Ownership Interest

BackgroundGastric bypass surgery is an efficient surgical intervention for the treatment of obese patients. The procedure can be performed either laparoscopically or robotic assisted. To simplify the intracorporeal handling of the suture material in a bi- or tri-dimensional plane, a new generation of sutures, named barbed sutures, has been developed recently and is being used for different indications. Barbed sutures allow knotless slippage-resistant suturing due to the self-anchoring elements distributed along the thread length and therefore obviate the need for assistance. Their safety and efficacy have been demonstrated in several meta-analyses and systematic reviews. In the present study, the clinical performance of a new unidirectional barbed suture material, which differs in regard to its configuration from other barbed suture materials, is analysed and compared to a conventional suture material in robotic-assisted gastric bypass surgery to treat morbid obesity.MethodsThe study will be performed as an industry-sponsored, mono-centre, randomized, active-controlled, two-arm, parallel-group, superiority trial. A total of 150 patients will be randomly allocated to both suture types in a 1:1 ratio. The suture material will be used to construct the gastro-jejunal anastomosis as well as the jejuno-jejunal anastomosis. The time needed to create both anastomoses is the primary endpoint. Intraoperative handling of both suture materials, patient satisfaction, pain, and complications occurring during the study will serve as secondary outcomes. Furthermore, the difference in quality of life using two different questionnaires (EQ5D5L and Bariatric Analysis and Reporting Outcome System (BAROS)) will be assessed preoperatively and postoperatively (30 days and 12 months) and will be compared between the suture groups as well as over time. The EQ-5D-5L questionnaire consists of five dimensions (mobility, self-care, usual activities, pain or discomfort, anxiety or depression) and a visual analogue scale (VAS) to record the patient’s health status. The BAROS evaluates three sub-categories: The percentage of excess weight loss, the changes in medical conditions, and quality of life, leading to three individual sub-scores, which are added to the final total score defining the failure or success of treatment. The follow-up period is 1 year after surgery.DiscussionTo our knowledge, the BARGASTRO study will be the largest randomized controlled trial investigating a barbed suture versus a conventional one in robotic-assisted gastric bypass surgery to treat obese patients. The study will provide and report clinical data on evidence level Ib.Trial registrationNCT05433688. Registered on 12 Oct. 2022

BackgroundAutistic adults constitute a growing and largely overlooked population with limited clinical and research resources. Social cognitive impairments are key deficits faced by this population, significantly impacting social interactions, educational and vocational functioning, and quality of life. Interventions targeting social cognition in autistic adults have shown promising results. Recent studies investigating the effect of virtual reality (VR)–based interventions for autistic adults have provided preliminary evidence supporting the feasibility and effectiveness of using this innovative technology. These studies indicate that VR interventions can enhance functional and social skills and improve specific neurocognitive and social cognitive functions. However, large-scale randomized clinical trials are urgently needed to fully assess the effectiveness of VR-based interventions for autistic adults.ObjectiveThis protocol aims to provide a comprehensive description of the design and methodology of the STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) trial.MethodsSTEPS is a clinical, randomized, assessor-blinded, parallel-group superiority trial. A total of 140 participants will be allocated to receive either virtual reality–based social cognitive training (VRSCT) + treatment as usual (TAU) or TAU alone. The experimental group will receive 12 weekly 1-hour sessions of VRSCT, aiming at improving psychosocial functioning and social cognition through exposure to virtual social environments. The intervention comprises 3 core modules, namely emotions, social understanding, and complex social interactions. The exact content and duration of TAU received by each participant will be mapped and documented upon trial completion. Assessments will be conducted at baseline, at cessation of the intervention (3 months post baseline), and at 6 months post baseline.ResultsParticipant enrollment began in May 2024. As of February 2025 (initial manuscript submission), 34 participants had been enrolled, increasing to 97 participants as of December 2025. Completion of enrollment is expected in April 2026. Data analysis is expected to begin in October 2026 following the final 6-month follow-up assessment. Results are anticipated in December 2026 and will be disseminated through peer-reviewed publications.ConclusionsTo our knowledge, STEPS is the hitherto largest randomized clinical trial globally investigating the effect of VRSCT for autistic adults. The results of this innovative intervention approach may significantly advance research in the field of autism. VRSCT holds potential to improve psychosocial functioning, quality of life, and co-occurring clinical symptoms, and to reduce social cognitive deficits in autistic adults. Establishing evidence-based interventions is crucial for addressing the debilitating psychosocial challenges faced by this population, especially considering the absence of established gold-standard treatments.

Recurrent acute pancreatitis (RAP) or acute-on-chronic flares in chronic pancreatitis (CP) have limited preventive options beyond addressing the underlying aetiology. Statins, due to their anti-inflammatory properties, have been proposed as a potential prophylactic treatment. We aimed to evaluate whether simvastatin could reduce the recurrence of pancreatitis. At 23 centres, we conducted a triple-blind, randomised, controlled, superiority trial enrolling patients with at least two episodes of RAP or CP flares in the previous 12 months. Participants were randomly assigned to receive simvastatin or placebo for 1 year. The primary endpoint was the recurrence of pancreatitis. The target sample size was 144 patients; however, an interim analysis was planned in the event of slow recruitment. A total of 85 patients (42.1% women) were included in the interim analysis. In the intention-to-treat analysis, no significant differences were observed regarding recurrence: 46.2% simvastatin versus 44.4% placebo; OR 1.07, 95% CI 0.43 to 2.66; p=0.88, or time to recurrence. No statistically significant differences were observed in recurrence in per-protocol analysis (35.5% simvastatin vs 41.9% placebo; OR 0.76, 95% CI 0.27 to 2.12; p=0.60). Development of diabetes mellitus was more frequent in the simvastatin group (4 vs 0 patients; OR not calculable, p=0.04). This trial, evaluating simvastatin versus placebo for the prevention of pancreatitis, did not demonstrate a reduction in recurrence rate, although results might be underpowered due to early termination. The relationship between statins in these patients and new-onset diabetes requires further investigation. NCT04021498.

P1128 Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch anal-anastomosis? The IDEAL trial

OBJECTIVE: To investigate the effectiveness and cost-effectiveness of an Internet-based self-management program compared with an online booklet for people with chronic musculoskeletal pain. DESIGN: Parallel-group, randomized controlled superiority trial with economic evaluation conducted in Brazil. METHODS: Patients with chronic musculoskeletal pain were randomly allocated to receive an Internet-based self-management program (ReabilitaDOR) or an online booklet. Participants were recruited from university- and community-based physical therapy clinics and through social media. The primary outcome was pain intensity at 8 weeks. The secondary outcomes were function; quality of life; kinesiophobia; global perceived effect; anxiety and depression; pain catastrophizing; pain-related attitudes and beliefs; self-efficacy; and adverse effects at 8 weeks, 6 months, and 12 months after randomization. The economic evaluation from the societal perspective was conducted for pain intensity and quality-adjusted life years (QALYs). RESULTS: We included 162 participants (ReabilitaDOR, n = 83; online booklet, n = 79). There was no statistically significant difference in pain intensity between groups at 8 weeks (mean difference: -0.74; 95% confidence interval: -1.5, 0.04), and no significant differences in the secondary outcomes. From a societal perspective, the intervention had a 0.98 probability of being cost-effective at a willingness-to-pay threshold of $200 per point of improvement in pain intensity and 0.63 at a willingness-to-pay threshold of $50 000 per QALY gained compared to the control group. CONCLUSION: An Internet-based self-management program was not superior to an online booklet for chronic musculoskeletal pain. The Internet-based self-management program seemed to be a cost-effective intervention for pain intensity, but not for QALYs. These findings should be interpreted with caution due to high dropout rates and the trial running during the COVID-19 pandemic. J Orthop Sports Phys Ther 2026;56(1):1-12. Epub 30 October 2025. doi:10.2519/jospt.2025.13418.

BackgroundHypertension (HTN) is a major non-communicable disease worldwide, including in Uganda. Studies have estimated HTN prevalence in Uganda between 19 and 33% among adults, with only 7–9% controlled within clinical target ranges. Isometric handgrip training (IHT), a form of resistance training that consists of performing multiple static forearm contractions separated by brief rest periods on a handgrip dynamometer or stress ball, is a promising simple, time-efficient, and low-cost intervention. This randomized controlled trial (RCT) aims to determine the efficacy of 12 weeks of IHT compared to standard of care on resting blood pressure (BP) levels in a population of hypertensive patients at the Soft Power Mukagwa Allan Stone Community Health Clinic (Kyabirwa, Uganda).MethodsThis study consists of a two-arm, parallel, randomized controlled, superiority trial. Patients having (1) a diagnosis of stage 1 HTN (BP > 140–159/90–99 mmHg), (2) not currently taking HTN medication, (3) not having been on HTN medication in the past 3 months, and (4) aged ≥18 years will be recruited. A total of 250 participants will be randomized with equal allocation to intervention and control arms. The control arm will receive standard care for HTN for a duration of 12 weeks, as per clinic standard practice. In addition to standard care, the intervention arm will perform IHT sessions three times a week for a duration of 12 weeks. IHT sessions will consist of four 2-min isometric handgrip contractions, using alternate hands with 1-min rest periods between contractions (total: 12 min). The primary outcome is the mean resting systolic BP at 12 weeks. Data collection will be conducted at baseline, 1, 2, and 3 months and will include measurements of BP levels and administration of questionnaires.DiscussionThis RCT will provide evidence on the efficacy of IHT, a promising and cost-efficient therapy for blood pressure control in a Ugandan context. We anticipate that our results will inform treatment strategies for hypertensive patients in Uganda and in other high-burden LMIC contexts.Trial registrationRetrospectively registered. ISRCTN Registry; ISRCTN46005092; 31/10/2024.Supplementary InformationThe online version contains supplementary material available at 10.1186/s13063-025-09258-y.

Proximal humerus fractures (PHF) are common in adults above 50years, often following low-energy trauma and underlying osteoporosis. Randomized trials in patients 60years and older have found no clinically important difference in 1- and 2-year outcomes between surgical and non-surgical treatments. There is limited evidence for the 50-65 age group, who may have different functional demands and even a different overall health status. There is limited knowledge to guide treatment decisions for this age group. A multicenter, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment in patients aged 50-65years with displaced PHF. A total of 60 patients will be randomized equally to surgical treatment (primary osteosynthesis) or non-surgical treatment. Follow-up visits are arranged at 6weeks and 6months for all patients, with an additional 12-week visit mandatory for the surgical group and optional for the non-surgical group. The primary outcome is the between-group difference in Oxford Shoulder Score at 12months. Sample size was calculated assuming a clinically relevant difference of 9.6 points on the OSS (SD 12), corresponding to 80% power at a 5% significance level. In case of treatment failure (persistent pain or a failed osteosynthesis), a salvage procedure will be offered. Patients not consenting to randomization will be asked to participate in a non-randomized cohort. They will have baseline data and preferences recorded, and they will receive the same follow-up and outcome assessments. Young shoulder CARE trial aims to provide insights into the treatment of displaced proximal humerus fractures in patients aged 50-65years, and to understand the benefits and harms of both surgical and non-surgical treatment options. The trial results will be published in an open-access peer-reviewed journal. Clinicaltrials.gov, NCT06416618, registered 14 May 2024.

A novel 'whole day' approach that could motivate the public to be more physically active is termed Snacktivity™. Consistent with guidance, the Snacktivity™ approach encourages the public to accumulate ≥ 150min of physical activity in short 2-5-min 'activity snacks' of moderate-vigorous intensity physical activity throughout the day/week. Snacktivity™ also promotes muscle-strengthening activity twice per week. Following completion of research to co-design and develop the Snacktivity™ approach, the aim of this trial is to assess the effectiveness and cost-effectiveness of a Snacktivity™ intervention to increase physical activity and reduce future risk of disease in the population, compared with usual care. A multi-centre, two-arm, individually randomised, parallel group, superiority trial, with an economic evaluation, will be conducted in 966 physically inactive adults. Participants will be recruited from National Health Service Trusts and organisations and non-National HealthService settings (e.g. community groups and social media). Participants will be individually randomized (1:1) to the Snacktivity™ intervention group or a usual care comparator group. The Snacktivity intervention involves two main components; a brief 5-min consultation about the principles and purpose of Snacktivity™; and access to technology support (mobile phone app called the SnackApp, linked to a Fitbit activity device (Versa 4)) that through behavioural change techniques promote self-monitoring of physical activity, habit formation, action planning and feedback on the number of activity snacks completed each day. The primary outcome is the difference in average minutes of moderate-vigorous physical activity between the groups at 12-months follow up, measured using a wrist worn accelerometer. Secondary outcomes include accelerometer-assessed average minutes per day of light, moderate, and vigorous intensity physical activity, time sedentary, weight and psychological health outcomes, at 12month follow-up. Innovative interventions such as Snacktivity™, that aim to support the public to increase their physical activity each day are required. Findings could inform future public health guidance and public health messaging that seeks to raise awareness in the population of the potential benefits of Snacktivity™ for health. ISRCTN: 12390945. Registered on 22 March, 2024.

Pancreatic fistula is a common complication after radical gastrectomy that can be fatal in severe cases. Currently, the avoidance of pressure and thermal injury to the pancreas is the main approach to preventing postoperative pancreatic fistula (POPF); however, its incidence still remains high and seriously affects the perioperative rehabilitation of patients. TissuePatch™ is an absorbable, synthetic, and easy-to-operate patch for sealing, which can effectively prevent liquid leakage on the tissue surface. Therefore, we explored whether TissuePatch™ covering the surface of the pancreas could effectively prevent the occurrence of pancreatic fistula after radical gastrectomy or reduce its severity. This is a prospective, single-center, randomized, clinical superiority trial. We will enroll 154 patients who meet the inclusion criteria but do not meet the exclusion criteria for this trial and randomly assign them to an experimental group (77) that uses TissuePatch™ to seal the pancreas surface and to a control group (77) that does not use TissuePatch™. The primary endpoint will be the incidence of POPF about radical gastrectomy. The secondary endpoints will be postoperative mortality, length of postoperative hospital stay, classification of pancreatic fistula, number of lymph node dissections, incidence of postoperative complications, and incidence of TissuePatch™-related complications, such as intestinal adhesion, intestinal obstruction, parenchymal atrophy of the pancreas, chronic pancreatitis, and allergic reactions. This trial is the first prospective randomized controlled trial to evaluate whether the use of TissuePatch™ to cover pancreatic capsular wound during radical gastrectomy reduces the incidence of POPF. We speculate that TissuePatch™ will significantly reduce the incidence of POPF and improve the prognosis of patients compared with the non-use group. Moreover, the results of the trial will provide a simple and effective new method for the prevention of pancreatic fistula after radical gastrectomy. This study was approved by the Chinese Ethics Committee of Registering Clinical Trials (ChiECRCT20220165) (V2.0). All results of the study will be available and published in peer-reviewed journals. ClinicalTrials.gov NCT05404256. Registered on May 20, 2022. This is the first prospective randomized controlled trial to evaluate whether the use of TissuePatch™ to seal the pancreatic tissue surface during radical gastrectomy reduces the incidence of POPF.If TissuePatch™ is shown to significantly reduce the incidence of POPF and improve the perioperative recovery of patients compared to the non-use group, it will be recommended and approved for future radical gastrectomy.Compared to other preventive measures, TissuePatch™ is simple and easy to perform and has a short intraoperative time and learning curve.Since this is a single-center study, the results need to be further validated in a multicenter randomized controlled clinical trial.