Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

ClinicalTrials.gov, NCT06619223.

Ambulatory care is defined as the provision of medical treatment by healthcare professionals outside an inpatient hospital setting. While well-established in acute medicine, uptake of ambulatory pathways in emergency general surgery (EGS) is variable and optimal design and delivery is unclear in this context. This systematic review sought to (1) appraise current EGS ambulatory pathway literature and (2) ascertain the constituent components across the identified pathways, guiding the development of comprehensive templates for future EGS ambulatory pathways.

Systematic review.

PubMed, Embase, Medline and Cochrane Library, from 5 December 2018 to 5 December 2023 inclusive.

All primary observational studies (ie, case–control, cohort studies and randomised controlled trials (RCTs)) were included. Case series and conference abstracts were excluded due to the high likelihood of incomplete data. Studies reporting paediatric or non-surgical populations, or ambulatory surgical care within a primary care setting, were also excluded.

General study characteristics (year and journal of publication, country of origin, study design, disease area, number of patients receiving ambulatory management and use of control groups) were recorded. To identify the constituent components of EGS ambulatory pathways, an initial subset of five papers was reviewed, from which four categories were identified (decision-making processes, scoring/classification systems, investigations and care escalation and discharge criteria). An additional fifth component (‘follow-up’) was identified during data extraction. Reporting of the constituent components of ambulatory pathways was also extracted, as well as outcomes including readmission, complications and mortality.

Of 43 included studies, there were 8 RCTs, 31 cohort studies and 4 studies using other methods. Reporting of all aspects of EGS ambulatory pathways was heterogeneous. 24 (56%) papers reported the specialty and grade of clinician acting as senior decision-maker. 17 different scoring/classification systems were used. 32 (74%) papers described using investigations to select ambulatory patients, including blood tests (n=12) and imaging (n=16). Eight studies (19%) specified both care escalation and discharge criteria. Information about follow-up was described in 29 papers, with location (n=29), time points (n=26), personnel (n=16) and the form of the follow-up (n=23) all reported variably. Readmission rates were recorded in 34 studies and ranged from 0% to 13%. Most studies (n=32) reported 30-day readmission, although 48 hours (n=1) and 90 days (n=1) were also used. Mortality was recorded in 24 papers, with 21 reporting a mortality rate of 0 and the remaining 3 reporting rates of

Key components of published EGS ambulatory pathways include decision-making processes, scoring/classification systems, investigations, care escalation and discharge criteria, and follow-up. However, this information is currently inconsistently reported. Future work to identify and agree on guidelines for the ‘core’ components of ambulatory EGS pathways is needed, to facilitate cross-study comparisons, and crucially, provide a ‘gold-standard’ framework for developing future ambulatory pathways.

Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.

Observational study based on prospectively collected registry data analysed retrospectively.

Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.

The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.

Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).

The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.

This study aims to describe the knowledge, attitude and practice (KAP) regarding surgical scars among patients who had postorthopaedic surgery, and to explore correlations between these factors.

A multicentre, cross-sectional, observational study.

Conducted across multiple secondary/tertiary care hospitals between July and September 2024.

Of 816 enrolled participants undergoing orthopaedic surgery, 54.5% were male, 43.6% were aged 31–45 years, 73.9% were urban dwellers, 31.2% had a bachelor’s degree and 65.4% were married.

None (questionnaire-based assessment).

Primary outcomes were KAP scores (knowledge: 0–22; attitude: 9–45 and practice: 7–35), analysed via correlation and regression.

Mean scores: knowledge (12.5±6.9), attitude (27.6±3.3) and practice (28.2±6.5). Knowledge was negatively correlated with attitude (r=–0.24, p

Patients who had postorthopaedic surgery demonstrated poor scar-related knowledge and negative attitudes but proactive practices. Greater knowledge correlated with better practice, suggesting targeted education could optimise scar management. Further research should explore causal relationships and the efficacy of interventions.

Surgery represents the cornerstone for the treatment of several benign and malignant oesophageal disorders. Yet synthesising the growing body of evidence from clinical research is becoming increasingly challenging. Evidence mapping with living systematic reviews (SRs) and living meta-analyses offers a structured, continuously updated approach to navigating emerging data. This study aims to provide a real-time, interactive resource to support evidence-based decision-making for oesophageal surgery.

This study follows PRISMA guidelines and uses the EVIglance Studio web application to develop a living evidence map in oesophageal surgery. A systematic literature search will be conducted across the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and MEDLINE (PubMed) to identify randomised controlled trials (RCTs) and SRs related to oesophageal surgery, without any date or language restrictions. Study selection and data extraction will be performed independently by two reviewers. Key clinical and surgical outcomes, including morbidity, mortality, quality of life and oncological endpoints, will be extracted. Risk of bias in RCTs will be assessed using the Cochrane Risk of Bias 2.0 tool, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system will be applied to evaluate the certainty of evidence. If at least three randomised trials address the same research question, a living meta-analysis will be conducted using random-effects models. The evidence map will be updated at least every 6 months.

This study does not involve individual patient data or any private information. Therefore, ethical approval is not required. As it uses only publicly available data, this study design qualifies as exempt from institutional review. The resulting evidence map is designed to support fast and structured access to high-quality surgical data - an approach not yet available in oesophageal surgery. The tool is expected to aid patients, clinicians and researchers alike by improving access to reliable information, supporting clinical decision-making and highlighting gaps in current evidence. On completion, results will be published in an open-access format and made permanently accessible via www.evidencemap.surgery, with continuous updates.

CRD420251022736 (https://www.crd.york.ac.uk/prospero/)

Shared decision-making (SDM) between clinicians and patients is considered ‘best practice’. There is limited evidence regarding SDM in surgery, particularly in the emergency setting. Emergency SDM may be particularly challenging due to: time pressures, the patient’s underlying condition and the nature of the patient-surgeon interaction. However, emergency surgery arguably has a greater need for SDM due to the likelihood of disparate outcomes from intervention, which is dependent on the various treatment options available. This is necessary for patients to make informed decisions regarding their treatment of surgical pathology. The primary objective of this scoping review is to understand the extent and type of evidence in relation to SDM in emergency surgery to determine methods for improving SDM.

Any studies reporting SDM in emergency surgery on adult patients (age >18 years) will be included. EMBASE, Medline, Cochrane, CINAHL and Scopus databases will be searched for articles with no language or date limits. Studies will be screened by two independent reviewers, with consensus met prior to data extraction. Data extracted to include study design, details of study population, tools used to measure SDM, prevalence of SDM and barriers and enablers for SDM.

A systematic narrative synthesis will be performed following JBI (Joanna Briggs Institute) guidance. These will summarise findings of included studies. The findings may inform future research into facilitating implementation of SDM in emergency surgery.

This study does not require ethical approval. Final findings will be submitted for peer-reviewed publication and presentation at surgical conferences.

This study aims to review whether both clinical and Patient Reported Outcome Measures (PROMs) of Reverse Shoulder Arthroplasty have improved over time using the National Joint Registry (NJR).

This study is a population-based cohort study using the NJR and Hospital Episode Statistics for England.

Publicly funded hospitals and procedures in England from 1 January 2013 to 31 December 2021.

All patients that received a reverse shoulder arthroplasty (RSA) in the specified time period. Patients were excluded if they had less than 1 year of follow-up.

Primary outcome was revision at one year. Secondary outcomes were non-revision re-operation and mortality at one year, length of stay (LOS) and mean change in Oxford Shoulder Score (OSS) from pre-operatively to 6 months post-operatively.

There were 24 411 RSA cases available for analysis. There was no significant improvement in revision rates over time; however, there was a significant reduction in non-revision re-operations (OR 0.93 (0.86–0.99) p=0.03) and mortality (0.96 (0.92–1.00) p=0.04). LOS over time improved with an average reduction of 0.24 days per year, ranging from a mean of 3.94 days in 2013 to 2.44 days in 2021 (p

Over the 9-year period recorded in the NJR, revision rates were low and remained similar. There has, however, been an improvement in other clinical outcomes such as non-revision reoperation and mortality as well as functional outcomes and reduced LOS, which demonstrates progress in the quality of care provided to shoulder replacement patients and is suggestive of advancements in surgical techniques, perioperative management and rehabilitation strategies.

Imposter Phenomenon is characterised by persistent self-doubt despite objective success. It has been associated with anxiety, burnout and reduced job satisfaction. Little is known about imposter phenomenon’s presence and impact in Trauma and Orthopaedic surgery. This study aims to determine the prevalence and predictors of Imposter Phenomenon among UK orthopaedic surgeons, further mapping domains that affect leadership and professional development.

Cross-sectional survey using the validated Clance Imposter Phenomenon Scale (CIPS).

The survey was distributed to UK orthopaedic surgeons between 20 October 2023 and 28 February 2024 via Training Programme Directors and the British Orthopaedic Association.

Orthopaedic trainees and consultant surgeons (n=441)

Imposter Phenomenon severity measured using CIPS (mild: 41–60, moderate: 61–80 and severe: 81–100). Univariate and multivariate analyses identified predictors of this severity. Self-reported impact of Imposter Phenomenon assessed across personal and leadership domains.

92% of respondents reported moderate to intense Imposter Phenomenon symptoms (mean CIPS=65.17). Trainees had significantly higher mean scores (70.64±13.85) compared with consultants (59.82±15.71). Female surgeons reported significantly higher mean scores (72.57±13.35) than male surgeons (61.19±15.74). Female gender, non-consultant training grade and time out of training were predictors of severity (p

The Imposter Phenomenon is highly prevalent among UK orthopaedic surgeons; disproportionately affecting women, trainees and those taking career breaks. Imposter Phenomenon significantly impacts leadership aspirations and career development, potentially contributing to reduced diversity in surgical leadership. Targeted interventions addressing Imposter Phenomenon are needed to support equitable leadership development in Trauma and Orthopaedic surgery.

Intracranial atherosclerosis is the main cause of stroke globally, with acute large vessel occlusive (LVO) stroke being a predominant contributor to stroke-related mortality. In recent years, aspiration thrombectomy (AT) has emerged as a novel therapeutic method for treating acute LVO stroke. The purpose of this study aims to investigate the safety and efficacy of AT alone or combined with stent retriever thrombectomy (SRT) in the treatment of acute LVO stroke

This is a multicentre and observational real-world study involving patients diagnosed with acute LVO stroke. Participants will be treated with AT alone or combined with SRT. According to the actual annual number of embolectomy in the sub-centre and the research years, the sample size of this study is estimated to be 400 patients, of which 300 patients of anterior circulation lesions and 100 patients of posterior circulation lesions are planned to be recruited, being considered that the incidence of posterior circulation is about 20–25%. Clinical data, including baseline characteristics, intraoperative details, postoperative outcomes and follow-up results, will be systematically collected using an Electronic Data Capture system over a follow-up period of 3 months. The primary efficacy endpoint is the rate of excellent functional outcome (modified Rankin Scale score range 0–3) after 90 days, and the successful recanalisation confirmed by digital subtraction angiography. The primary safety outcome is symptomatic intracranial haemorrhage within 48 hours (National Institutes of Health Stroke Scale score increase ≥4). This study will provide us with powerful guidance for the treatment of acute LVO stroke with different aetiologies.

This study protocol was approved by the Ethics Committee on Human Experimentation at Shandong Provincial Hospital Affiliated to Shandong First Medical University (approval number: SWYX:2022–1025). All the participating sites have received the ethics approval. The outcomes will be disseminated through national and international presentations and peer-reviewed publications.

ChiCTR2200065172.

The management of bleeding and coagulation after total knee arthroplasty (TKA) has long been recognised as a significant challenge for orthopaedic surgeons. Despite the notable success of empirical anticoagulation in preventing venous thromboembolism (VTE) following TKA, the increased risk of postoperative bleeding has also raised extensive concern. Ecchymosis, as one of the most common manifestations indicating postoperative bleeding, holds the potential to indicate the balance of bleeding and hypercoagulation. However, there is still a lack of evidence-based medical research to determine the importance of postoperative ecchymosis and related personalised anticoagulation therapy. Therefore, we have designed a randomised controlled trial aimed at assessing the safety and efficacy of personalised delayed anticoagulation strategies in the management of postoperative bleeding in TKA patients.

This is a prospective, randomised, controlled trial. Patients diagnosed with end-stage knee osteoarthritis will be grouped based on the presence of ecchymosis after TKA. Those without ecchymosis will receive standard anticoagulation therapy, while those with ecchymosis will be randomised in a 1:1 ratio into either the standard anticoagulation group or the delayed anticoagulation group. The primary outcomes will compare the blood routine examination, coagulogram, thromboelastography and the incidence of VTE. The secondary outcomes will include surgical-related complications. Additionally, patient baseline data and surgery-related data will also be recorded and analysed.

Ethics approval has been obtained from The First Affiliated Hospital of Chongqing Medical University (2024-194-01). The results will be disseminated at international conferences and in peer-reviewed publications.

ChiCTR2400084440.

This scoping review aimed to synthesise the currently available evidence and influencing factors on the occurrence of postoperative urinary retention (POUR) in older patients with hip fractures.

This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guideline.

PubMed, Cochrane Library, CINAHL, Web of Science, Chinese National Knowledge Infrastructure, Wanfang Data and Sinomed databases were systematically searched from database inception to 1 September 2024.

We included observational studies reporting on POUR prevalence and risk factors among patients aged 60 years and older with hip fractures and excluded systematic and non-systematic reviews, conference proceedings, editorials, commentaries, qualitative studies and case studies. Duplicated articles and articles unable to access the full text were also excluded. We also excluded studies with populations with pathologic fractures, multiple fractures, treated for periprosthetic fracture, or if studies were published in a language other than English and Chinese.

Two authors independently extracted and summarised the data. We summarised the prevalence and risk factors for POUR in older patients with hip fractures.

A total of 106 studies were identified, and 12 studies (all from published literature sources) detailing POUR prevalence and risk factors were included. The studies showed that the incidence of POUR in older patients with hip fractures ranged from 11.10% to 51.33%, and the risk factors included impaired activities of daily living, use of anticholinergic medications, serological indicators (serum albumin and thyroid-stimulating hormone), complications (urinary infection and postoperative incontinence), prolonged indwelling urinary catheters and faecal impaction. In addition, male sex, cognitive impairment, use of opioid medications and coexisting diabetes may also be risk factors for POUR, which still needs to be further clarified

The incidence of POUR in older patients with hip fractures varies widely. Most factors were reported in one study with no proposed underlying mechanism for their influence. Further high-quality studies are needed to validate these findings.

Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.

We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.

The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).

NCT06731751.

Knee osteoarthritis often starts in the patellofemoral compartment of the knee and is diagnosed in about 39% of people with knee pain aged above 30 years. Patellofemoral osteoarthritis plays a crucial role in the reduction of quality of life and in the rise of healthcare costs. There is still no consensus for treatment recommendation for isolated patella-femoral osteoarthritis in clinical guidelines. Current therapeutic approaches are limited to pain management, alleviation of symptoms or total knee replacement. Nasal chondrocyte tissue-engineered cartilage (N-TEC) has already been successfully introduced in clinical studies phase I and II for the treatment of focal cartilage lesions and in pilot studies in osteoarthritis patients.

A randomised controlled trial involving 75 patients with patellofemoral osteoarthritis from nine different clinical centres in Switzerland, Germany and Croatia is being conducted to evaluate the effectiveness of N-TEC implantation compared with standard treatment with platelet-rich plasma (PRP). In the intervention group, an autologous nasal cartilage cell-derived graft is implanted into the cartilage defects of the patella and/or trochlea during an open surgical procedure. The control group receives three PRP injections at weekly intervals. The primary outcome is the mean Knee Injury and Osteoarthritis Outcome Score Pain Change from baseline to 24 months between groups. Secondary outcomes, including patients’ self-assessed questionnaires, X-ray and MRI scans, physiotherapeutic assessments and safety, will be assessed and compared between the intervention and control group. In addition, the study is complemented with a health-economic evaluation to establish the intervention’s value for money and impact on productivity in working-age individuals. The planned duration of the study is 4 years including baseline and follow-up measurements at 6, 12 and 24 months.

All centres involved in the implementation of the intervention have obtained approval from their respective competent ethics committees. This includes approval from the following ethics committees: Ethics Committees of North-Western and Central Switzerland (EKNZ): 2024–00075 (associated ethical committees: Cantonal Ethics Committee Bern, Cantonal Research Ethics Commission Geneva (CCER), Cantonal Ethics Committee Ticino, Cantonal Ethics Committee Zurich). The EKNZ covers several cantons in Switzerland, including Basel. The site in Lugano falls under the Cantonal Ethics Committee Ticino. Ethics Germany according to CTIS: 2023-508640-21-00 (Medicinal Ethical Commission of the Julius-Maximilians-University Wuerzburg, Ethical Commission of the Albert-Ludwigs-University Freiburg) and Central Ethical Committee Croatia, Republic of Croatia Ministry of Health: 2023-508640-21-00. The Swissmedic reference number is 701788.

Prior to participation, all participants must have signed informed consent. Study information will be disseminated via hospital websites, newsletters and an open-access publication of the protocol. Results will be published in peer-reviewed journals, presented at national and international conferences and shared with the public.

ClinicalTrials.gov Registration No.: NCT06163573; Registration number CTIS: 2023-508640-21-00.

Acute unstable syndesmosis injuries require accurate reduction and stable fixation to improve short-term and long-term outcomes. Several different fixation methods have been established for acute syndesmosis injuries, each with pros and cons. Although some meta-analyses have reported better outcomes with suture-buttons than screws, the optimal fixation method remains uncertain because of heterogeneous study results and limited comparisons of emerging techniques. This network meta-analysis combining randomised and observational studies aims to determine the optimal fixation method for acute syndesmosis injuries.

Five electronic databases (PubMed, Cochrane Library, China National Knowledge Infrastructure, Wanfang Data and Embase) will be comprehensively searched from their inception through 1 June 2025 for randomised and observational studies, published in English or Chinese, that compared two or more fixation methods for acute syndesmosis injuries. Inclusion and exclusion criteria will be used for selection based on patient, intervention, comparison, outcome and study standards. Risk of bias will be evaluated by the Cochrane risk-of-bias tool 2 and the Newcastle–Ottawa scale, respectively. Conventional pairwise meta-analyses with the DerSimonian–Laird random effects model will be conducted first, followed by network meta-analyses with a three-level Bayesian hierarchical model. The outcome measures include functional outcomes, radiological indicators and postoperative complications. Data analysis will be conducted using Review Manager 5.3 and R 4.1.2. Heterogeneity, transitivity and inconsistency tests, subgroup and sensitivity analyses and publication bias will also be assessed.

No ethical approval is required because all the data will be collected from published research. The results of this study will be published in a peer-reviewed journal.

INPLASY202480027.

Cleft lip and palate significantly impact a child’s speech and facial appearance. Children undergo cleft repairs in infancy, but poor results from these initial repairs often lead to secondary surgery. In the late 1990s, cleft care provision in the UK was centralised to approximately 11 managed clinical networks or centres. This centralisation has been associated with improvements in speech and aesthetic outcomes, but little is known about the effect of centralisation on the use of secondary surgery. The purpose of this study was to compare the cumulative incidence of secondary cleft surgeries before and after centralisation and the proportion of children achieving good clinical outcomes without secondary surgery.

Retrospective, cross-sectional.

Two cross-sectional studies of 5-year-old children with non-syndromic unilateral cleft lip and palate were conducted, one precentralisation and one postcentralisation.

The cumulative incidence of secondary surgery from birth through age 5 was compared precentralisation and postcentralisation using Fisher’s exact test, as were facial appearance and speech outcomes at age 5. Risk ratios (RR) were estimated using log-binomial multivariable regression models that adjusted for sex and age at evaluation.

Postcentralisation, the proportion of children achieving good or excellent facial appearance increased from 16% to 42% (p

Centralisation of cleft care was associated with improved outcomes of primary lip and palate repairs and a corresponding reduction in secondary surgery.

Proximal gastrectomy (PG) has emerged as the preferred surgical approach for adenocarcinoma of the upper 1/3 stomach and selected cases of oesophagogastric junction adenocarcinoma. We developed a novel oesophagogastric anastomosis technique with an antireflux mechanism (Hao’s Esophagogastrostomy by Fissure Technique). It may have a superior effect on patient weight maintenance compared with the double-tract reconstruction. We intend to conduct a prospective, multicentre, randomised controlled clinical trial to validate this hypothesis.

The primary objective evaluates body weight loss at 12 months postoperatively. Secondary objectives assess surgical safety through comprehensive analysis of complication rates and nutritional parameters, including serial haematological evaluations during follow-up. The study will enrol 52 participants across multiple centres with planned 3-year longitudinal monitoring to evaluate both immediate postoperative outcomes and intermediate-term clinical impacts.

This study was approved by the hospital institutional review board of Huashan Hospital, Fudan University (2024-1173) and is being conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. On completion of the study, the results will be published in a peer-reviewed journal.

NCT06679244.

Robotic-assisted proximal gastrectomy with double flap technique (RPG-DFT) reconstruction has been used to treat proximal early gastric cancer and reconstruct the digestive tract in recent years. However, due to the complexity of this surgical procedure, all of the reports were retrospective. The application of RPG-DFT in the context of proximal early gastric cancer remains a nascent area of investigation. Large-scale, prospective trials are necessary to assess the feasibility and safety of RPG-DFT for proximal early gastric cancer.

This study is a phase II, multicentre, single-arm clinical trial that investigates the feasibility and safety of RPG-DFT for proximal early gastric cancer. A total of 42 eligible patients who met the inclusion criteria will be allocated to the RPG-DFT group. General and clinical data will be collected at the time of patient enrolment and maintained in accordance with the patient’s progress throughout their medical and follow-up care. The primary endpoint is the proportion of patients with reflux oesophagitis (Los Angeles Grade B or more) within 12 months postoperatively. The secondary endpoints included intraoperative outcomes, postoperative recovery, postoperative pain assessment, pathological outcomes, postoperative quality of life, postoperative nutritional status, morbidity and mortality rate.

The protocol was approved by the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Ethics Committee (registration number: SYSKY-2022-275-02) on 28 September 2022. We will report the findings in international peer-reviewed journals.

NCT05892289.

Acute abdominal pain is a chief complaint in emergency departments and represents 7%–10% of emergency room (ER) visits. Acute appendicitis represents 15% of the causes of abdominal pain and 62% of the causes that require surgical treatment. Opioid analgesia has been evaluated in clinical trials, and they have determined it does not impact diagnostic accuracy. Despite evidence, withholding analgesia is still a common practice. Pain severely impacts quality of life and analgesia has become essential in humanised medicine. We aim to determine the safety and effectiveness of different opioid regimens for adult patients that present to the ER with acute suspected appendicitis.

We will search MEDLINE and Embase via Ovid, and the Cochrane Central Register of Controlled Trials without restrictions on the study publication date. Screening, extraction and risk of bias assessment will be performed in duplicate. We will use the Cochrane Risk of Bias Assessment Tool. We will perform both pairwise meta-analysis and network meta-analysis (NMA) if transitivity and coherence principles are met. Heterogeneity will be evaluated using the I² and ² and using the thresholds recommended by Cochrane. We will perform sensitivity analysis based on the pre-established potential effect modifiers, risk of bias and data that required transformation or imputation. Publication bias will be addressed by using funnel plots on a pairwise level. We will assess the strength of the body of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE) per outcome, and evidence from the NMA will be assessed using the GRADE approach for NMA.

Approval by an ethics committee is not required for this study since no personal information will be handled. Information will be disseminated by publication on a peer-reviewed journal.

CRD42024583804.

Endovascular therapy is the main treatment for chronic limb-threatening ischaemia in the UK. Despite a restenosis risk of 50% over 2 years, reintervention rates are low, potentially resulting in preventable amputations. European guidelines recommend ultrasound surveillance to facilitate early treatment of restenosis. This study will investigate the use of duplex ultrasound after endo revascularisation (DUSTER). The aim is to assess the feasibility, acceptability and impact on clinical decision-making of a 1-year integrated ultrasound surveillance programme after lower limb endovascular therapy.

DUSTER is a mixed-methods study. Phase I is a three-site, feasibility, open-label, randomised controlled trial. The standard of care, the control arm, is standard clinical surveillance by a vascular specialist at 1, 6 and 12 months. The intervention arm will receive integrated ultrasound (ankle-brachial pressure index, toe pressure and duplex) plus standard clinical surveillance. Primary outcomes are rates of attendance and completion of ultrasound surveillance tests, as well as the percentage of participants undergoing reintervention for restenosis. Secondary outcomes are limb salvage, amputation-free survival, reasons for amputation, complications, serious adverse events and mortality.

Phase II comprises independent semistructured interviews with intervention arm participants. The interviews will explore barriers and facilitators to ultrasound surveillance and the effect of ultrasound surveillance on patients’ lives.

Phase III has two separate focus groups for participants and clinical stakeholders to identify which outcomes matter most in any subsequent large-scale effectiveness trials.

This research has been approved by a UK (West Midlands, Black Country) Research Ethics Committee (reference 24/WM/0232) and the Health Research Authority (IRAS 349192). Dissemination of results will be by the DUSTER co-investigators in peer-reviewed journals, to the National Institute for Health and Care Research and to a lay audience via the Mid and South Essex NHS Foundations Trust website.

NCT06702306.

Postoperative delirium is a serious complication occurring in 10.09%–51.28% of geriatric patients undergoing surgery for hip fractures. Delirium has resulted in poorer functional recovery, increased readmission rates, repeat surgeries and elevated mortality. Perioperative music listening is a promising non-pharmacological intervention with beneficial effects on delirium. This trial aims to evaluate the effect of perioperative music listening on postoperative delirium in patients with femur fracture undergoing surgery.

The music listening on clinical outcome after hip fracture operations study is an investigator-initiated, randomised controlled, clinical trial. 102 patients with femur fracture meeting eligibility criteria will be randomised to the music listening intervention or control group with concealed allocation. The perioperative music intervention consists of preselected lists totalling 4 hours of music (classical, jazz and pop). The primary outcome is postoperative delirium rate. Secondary outcome measures include pain score and opioid medication requirement, postoperative complications, hospital length of stay, 14-day readmission rate and 30-day mortality. A 90-day follow-up will be performed in order to assess readmission rate and mortality rate. Data will be analysed according to an intention-to-treat principle.

The study protocol was approved by the Research Ethics Committee of Ditmanson Medical Foundation of Chia-Yi Christian Hospital (IRB2023084). The trial will be carried out following the Declaration of Helsinki principles and Good Clinical Practice guidelines. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal and presented at scientific conferences. Data availability statement: data generated by this study will be made available on reasonable request. A data sharing plan has been submitted to ClinicalTrials.gov in compliance with ICMJE (International Committee of Medical Journal Editors) and BMJ Open data policies.

NCT06209788.