Background Catastrophic healthcare expenditure (CHE) poses significant financial burdens on households globally, particularly in low- and middle-income countries. This study was designed to determine the prevalence of CHE among families of paediatric surgical patients admitted for surgery and to explore factors associated with it.Methods The study was a prospective, multicentre, cross-sectional study carried out in 25 hospitals with paediatric surgery in Nigeria from July to November 2024. Consecutive patients below 16 years of age who underwent surgery were included. CHE was defined as health expenditure above 10% of the head of household annual household income. Data on demographic data, educational and employment status of parents and other related factors were collected and analysed using Stata.Results A total of 1665 patients were recruited with ages ranging from 5 days to ≤16 years (median=4.74 years). Overall median annual income for the heads of household was US$1097.78. The median (IQR) cost of care was US$129.81 per patient and 56.3% of households spent out of pocket and only 11.7% of households had access to health insurance.A total of 981 households (58.9%; 95% CI 56.5% to 61.3%) experienced CHE. The CHE incidence rate ratio (IRR) decreased among households where the patients were male (IRR 0.92 (95% CI 0.86 to 0.98); p=0.011), the head-of-households had a graduate/postgraduate education (IRR 0.64 (95% CI 0.53 to 0.78); p<0.001), but increased when major surgery was performed (IRR 1.25 (95% CI 1.08 to 1.44); p=0.002) and with prolonged hospital stay (1.008 (95% CI 1.005 to 1.011); p<0.001).The main sources of funds for healthcare were out-of-pocket (n=936, 56.3%) and availability of health insurance was significant in preventing CHE, as three of every four households accessing health insurance did not experience it.Conclusion Catastrophic health expenditure was highly prevalent among families of children who underwent surgery in Nigeria, particularly among those who had major and emergency surgeries.
Background: The European Society of Coloproctology (ESCP) conducted a global survey capturing wound closure practices across a spectrum of surgical contexts, including clean-contaminated and contaminated operations. The results revealed considerable variations in fascial closure techniques, suture types, and infection prevention measures, even within comparable operative scenarios. This variability highlights the urgent need for high-quality, real-world data to inform the development of evidence-based, globally relevant best practices in abdominal surgery. Method: The WOLVERINE study is an international, prospective, multicenter cohort study designed to evaluate current wound closure techniques and surgical site infection (SSI) prevention strategies in adult patients undergoing general or colorectal abdominal surgery. The primary objective of this study is to investigate the relationship between wound closure materials and techniques and the development of early and late wound complications. Further objectives include quantifying the burden of wound complications on patient-reported outcomes, health-related quality of life, healthcare utilisation, and postoperative recovery timelines. Participating centres include any hospital or surgical unit performing elective, expedited, or emergency abdominal, general, and colorectal operations via open, laparoscopic, or robotic approaches. This study adheres to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for reporting cohort studies. Discussion: The WOLVERINE cohort study will provide the first truly global, prospective portrait of abdominal wall closure practice and its short- and long-term sequelae across the full spectrum of elective, expedited, and emergency general and colorectal surgery. This project bridges this fundamental knowledge gap.
17 Background: The FOxTROT trial reported advantages of neoadjuvant chemotherapy in LACC. An embedded phase II trial tested neoadjuvant FOLFOX+panitumumab vs FOLFOX and reported a trend towards a TTR benefit and a significant DFS and OS benefit from panitumumab (pan) in RAS/BRAF -wt patients (pts). ERBB2 and ERBB3 overexpression have putative negative and positive predictive effects on pan efficacy, respectively. Here we examined whether ERBB2/3 could improve patient selection for neoadjuvant pan. The additional impact of AREG/EREG expression (EGFR ligands) on pan efficacy was tested. Methods: In FOxTROT, 279 pts with cT3-4 N0-2 M0, KRAS -wt LACC were randomized 1:1 to neoadjuvant FOLFOX±pan (6 weeks). All pts received FOLFOX post-op. 169 (61%) were confirmed RAS/BRAF -wt by NGS. ERBB2/3 and AREG/EREG were tested by RNAseq. Endpoints in this exploratory analysis were TTR, DFS, CCSS and OS. Results: 157 (93%) pts had available ERBB2/3 data. Median follow-up was 49 months. There were no associations between ERBB2/3 and stage, primary tumor location or MMR status. ERBB2 and ERBB3 were dichotomized using internally derived cut-points at the 50 th and 40 th percentiles respectively. Trends were consistent across all endpoints but strongest for DFS and OS, presented here. ERBB2 expression had no association with pan efficacy: trends towards benefit from FOLFOX+pan vs FOLFOX were similar in ERBB2 -high (DFS: HR 0.45 [95% CI 0.17-1.19], P = 0.11; OS: 0.40 [0.12-1.38], P = 0.15) and -low pts (DFS: 0.60 [0.23-1.59], P = 0.30; OS: 0.24 [0.05-1.18], P = 0.08). ERBB3 enabled improved patient selection for neoadjuvant pan: ERBB3 -high pts had significant benefit from FOLFOX+pan vs FOLFOX (DFS: 0.37 [0.14-0.97], P =0.04; OS: 0.16 [0.04-0.75], P =0.02), whereas ERBB3 -low pts did not (DFS: 0.80 [0.29-2.22], P =0.67; OS: 0.71 [0.18-2.84], P =0.63). Tests for interaction did not reach significance in this subgroup analysis (DFS: P interaction =0.28; OS: P interaction =0.14). We have previously reported the ability of AREG/EREG to predict pan benefit in this dataset. ERBB3 strengthened the predictive effect of AREG/EREG : AREG , EREG and/or ERBB3 -high pts had significant benefit from FOLFOX+pan vs FOLFOX (DFS: 0.38 [0.17-0.82], P =0.01; OS: 0.22 [0.07-0.67], P =0.008), while there was a trend towards disbenefit from pan in AREG , EREG and ERBB3 -low pts (DFS: 2.58 [0.50-13.31], P =0.26; OS: 3.05 [0.32-29.35], P =0.33). Biomarker-treatment interactions were significant (DFS: P interaction =0.03; OS: P interaction =0.045). AREG/EREG and ERBB3 were not correlated, suggesting differing underlying biology. Conclusions: High ERBB3 expression predicted benefit from neoadjuvant FOLFOX+pan. ERBB3 augmented the known predictive effect of the EGFR ligands, AREG/EREG . Validation in a biomarker-enriched trial is warranted. There was no association between ERBB2 expression and pan efficacy. Clinical trial information: NCT00647530 .
Abstract Background People with multiple long-term conditions (MLTC) are common in elective surgery, yet current pathways remain poorly equipped to meet their complex needs. These pathways presents a unique, time-sensitive opportunity to act. This study aimed to co-design a feasible intervention that integrates MLTC care into surgical pathways. Methods We conducted a mixed-methods theory-informed co-design study (NIHR / MRC Complex Intervention framework): Phase I was a contextual analysis of current UK pathways: pathway mapping, policy scan, national survey; and phase II, a multidisciplinary stakeholder workshops to develop a Theory of Change. Results In phase 1, pathway mapping identified variation and delayed pre-assessment, resulting in limited window to optimise chronic diseases. The scoping review found no UK guidance integrating MLTC into surgical pathways. In the survey (73 responses, 51 NHS Trusts), few services screened at listing and structured pathways were uncommon. Only one-in-ten hospitals had a MLTC-specific care pathway for elective surgical patients, primarily focussing on diabetes or anaemia management. In phase 2, stakeholders (n=21) agreed a pragmatic intervention prioritised on four domains, diabetes, hypertension, weight management and smoking cessation, with five intervention components: (i) surgeon-led checklist-based early identification at listing; (ii) automated referral to primary care/specialist services; (iii) patient-activation materials; (iv) optimisation during waiting time; and (v) structured discharge communication. Conclusions This study presents a co-designed model shifting MLTC care upstream to point of listing. Although this model offers the potential to improve short- and long-term health, closing knowledge gap on its clinical effectiveness is required before broader implementation into the NHS.
3653 Background: The FOxTROT1 (FT1; NCT00647530) trial demonstrated feasibility and efficacy of six weeks of NAC for LACC compared with upfront surgery. The currently recruiting FOxTROT2 trial (ISRCTN83842641) is testing this approach in older or frail patients. Outcomes in older patients with LACC are inferior; therefore, new treatment strategies are required. Here in these trials we analyse the safety and efficacy of NAC in this group and report the DFS in the older subgroup of FT1 PMMR patients. Methods: Data from FT1 and the planned FT2 safety pilot (n=150) were combined and analysed by treatment arm and by age category (> 70). Pre-specified endpoints included NAC delivery and perioperative complication rates for FT1 and FT2; DFS and pathological response are reported for FT1 patients by MMR status. We will update safety data for this presentation. Results: In FT1 292/1052 (27.8%) of patients were aged over 70; the median age of FT2 safety cohort was 76 (range 70-85). There were no significant differences by age in NAC delivery or in rates of peri-operative complications. For patients over 70, combining FT1&2 data, exploring those who received NAC, 88.5% completed the course as planned and 37.7% received an upfront or subsequent dose modification. Rates of peri-operative complications combining FT1&2 were similar between patients receiving NAC or upfront surgery: anastomotic leak (3.4% vs 3.3%), complication requiring hospital stay (FT1 9.3% vs 14.6%) or further surgery (2.6% vs 5.0%), and post-operative death (0.9 % vs 1.7%). For patients over 70 in FT1 16.4% were dMMR and 83.6% were pMMR. In pMMR patients overall NAC improved 3-year DFS (81.2% vs 75.4% without a DFS event; HR 0.70[0.52–0.94],p=0.02) compared with upfront surgery; results were consistent in older patients (81.2% vs 71.4%; HR 0.59[0.35-1.02],p=0.06). Conclusions: NAC is safe and well-tolerated in older adults, with no increase in perioperative morbidity and preserved treatment delivery compared to rates in younger patients and when compared with upfront surgery. Promising efficacy in terms of 3-year DFS and pathological response were observed in older patients with pMMR tumors, consistent to those seen in younger patients. These data support the use of NAC in older patients with LACC and continued recruitment to FT2 to evaluate the long term impact. Clinical trial information: NCT00647530 .
Abstract Background Anastomotic leak (AL) is the leading cause of major morbidity after right colectomy, affecting 5–10% of patients and accounting for up to one-third of postoperative deaths. The multicentre EAGLE randomized trial demonstrated reductions in AL when surgeons completed a digital safe-anastomosis training package, but its effectiveness outside a trial setting remains untested. Methods EAGLE-2 was an international prospective cohort study conducted across participating centres over an 8-week intervals (June–September 2024). Consecutive adults undergoing right colectomy surgery with primary anastomosis were included. The EAGLE safe-anastomosis training platform was made open access and surgeons were categorized according to whether they had completed the modules before surgery. The primary outcome was 30-day AL, defined as a defect of intestinal wall integrity at the anastomotic site leading to frank AL and/or intra-abdominal collection. Secondary outcomes included collection alone, training uptake, and implementation of the recommended checklist. Mixed-effects logistic regression adjusting for ASA grade, urgency, and intraoperative contamination was performed with hospital as a random effect. Results A total of 2875 patients were recruited across 332 hospitals in 60 countries. Of these, 2242 (78.0%) operations were performed by trained surgeons and 633 (22.0%) by untrained surgeons. AL/collection occurred in 16.4% of the non-trained group versus 9.1% of the trained group, giving a difference of 7.3% (P < 0.001). Adjusted analysis found training was associated with almost a halving of the OR for AL (adjusted OR (aOR) 0.56 (95% c.i. 0.41 to 0.78)), as well as lower reoperation (aOR 0.64) and readmission (aOR 0.65) rates. Conclusion Completion of a brief digital training programme was associated with a clinically and statistically significant lower rate of AL after right colectomy, alongside lower rates of reoperation, readmission, and death. Scalable digital education should be embedded into colorectal quality improvement programmes worldwide.
AIM:The aim of this study was to evaluate the prevalence of faecal incontinence (FI) among patients attending colorectal clinics in a global setting, treatment choices and accessibility to diagnostic and treatment tools. METHODS:An international, prospective, multi-centre snapshot audit and survey of patients undergoing consultation regarding FI was undertaken from January 9 to February 28, 2023. Participating units included patients in the audit who presented until March 28, 2023. Main outcomes measured included the prevalence of FI in clinical practice, diagnostic approaches, treatment patterns and availability of interventions. RESULTS:A total of 1853 outpatients with FI and 363 surgical patients were included, representing a prevalence of 6.3% of total clinic attendance over the same period. The majority of patients were female (75.3%), parous (85% of females). Patients presented with passive and urge incontinence, or both, in fairly even proportions (34.8 vs. 29.4 vs. 33.7%, respectively). Aetiology was most commonly anal injury (surgical or obstetric: 15.4% vs. 19.8%, respectively), but with significant proportions of other surgical conditions, such as low anterior resection syndrome (11.1%) and rectal prolapse (12.7%). In the surgical audit (n = 363), the majority of patients had received previous treatment (61.1%), including pelvic floor physiotherapy (67.1%), bowel retraining with biofeedback (51.4%), and nurse-led continence support (40.5%). Of 395 procedures performed, sacral neuromodulation was the most common (28.9%), followed by sphincteroplasty (22.0%). In the global practice survey (n = 250 respondents), endoanal ultrasound (EAUS) (82.4%) and anorectal manometry (74.4%) were the most available diagnostic tools. CONCLUSIONS:Globally, FI forms a significant part of colorectal surgeons' clinical workload, with a skew toward structural causes of FI. Practice varies according to the availability of diagnostics and procedures.
Introduction Multimorbidity or the presence of two or more long-term conditions is now common in people undergoing surgery. However, current care pathways often miss these healthcare encounters to support long-term health promotion. Therefore, there is a need for practical, scalable approaches that can be integrated into routine surgical care, for which limited solutions exist at present. We have co-designed a structured preoperative checklist to help identify and manage long-term conditions in patients listed for elective surgery. This study aims to evaluate the feasibility and acceptability of this preoperative checklist in patients undergoing elective surgery.Methods and analysis This is a mixed-methods feasibility study in one National Health Service trust in the UK. We will recruit up to 50 adults scheduled for elective surgery and use the checklist during initial surgical clinic appointments. Quantitative data will include recruitment and retention rates, completion of the checklist and baseline clinical characteristics, analysed using descriptive statistics. Qualitative data will be collected through semistructured interviews with up to 16 patients and clinicians. These interviews will be analysed thematically, guided by the Consolidated Framework for Implementation Research. Triangulation of quantitative and qualitative data will allow us to explore fidelity, acceptability, barriers and facilitators to implementation and refine the intervention ahead of a future pilot cluster randomised trial.Ethics and dissemination This study has received approval from the Yorkshire & The Humber - Sheffield Research Ethics Committee (approval number: 25/YH/0045). All participants will give written informed consent. Results will be published in peer-reviewed journals and shared with participants, the public and policy stakeholders.
Background: The FOxTROT trial has reported advantages of neoadjuvant chemotherapy (NAC) in locally advanced colon cancer (LACC). In this article, we present results of the embedded randomised phase II trial testing the addition of panitumumab to neoadjuvant FOLFOX compared with FOLFOX alone in RAS and BRAF-wild-type (wt) patients and with biomarker hyperselection. Patients and methods: Patients had operable, computed tomography-predicted stage T3-4, N0-2, M0 colon adenocarcinoma. KRAS-wt patients allocated to NAC could optionally be sub-randomised 1 : 1 to FOLFOX +/- panitumumab during the preoperative phase. RAS/BRAF were tested by next-generation sequencing; and epiregulin (EREG)/amphiregulin (AREG) by RNAseq. The primary endpoint was time to recurrence (TTR) in RAS/BRAF-wt patients; secondary endpoints included safety, histological down-staging, disease-free survival (DFS), colon cancer-specific survival (CCSS), overall survival (OS) and impact of primary tumour location and EREG/AREG. Results: In total 269 KRAS-wt patients were enrolled into the embedded phase II trial. Extended RAS/BRAF data were available for 232 (83%) patients; 22/232 (9.5%) were RAS-mutant; 41/210 (20%) were BRAF-mutant. Median follow-up was 42 months. In 169 RAS/BRAF-wt patients, there was a trend towards reduced recurrences with FOLFOX plus panitumumab compared with FOLFOX (12% versus 21%, hazard ratio = 0.51, P = 0.09); significant improvements were seen for DFS, CCSS and OS. Within the hyperselected EREG/AREG-high group, there was significant reduction in recurrences with panitumumab. Panitumumab was not associated with increased pathological regression of the primary tumour (tumour regression grade 1-3 16% versus 22%, P = 0.27). FOLFOX plus panitumumab was associated with higher rates of grade 3 diarrhoea (8% versus 3%) and rash (22% versus 2%). Conclusion: This exploratory analysis from a randomised phase II study shows a non-significant improvement in TTR from the addition of neoadjuvant panitumumab to perioperative FOLFOX in RAS/BRAF-wt LACC. Hyperselection with EREG/AREG status was associated with increased efficacy. A dedicated prospective trial within a biomarker-selected population is under development.
Introduction Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.Methods and analysis This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this 'shadow-mode' study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.Ethics and dissemination Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.Trial registration number NCT06565559.
BACKGROUND:Reuse of sterile textiles could potentially reduce the carbon footprint of operating theatres. The aim of this mixed-methods study is to gain a deeper understanding of the implementation of reusable drapes and gowns across different contexts through applying the Consolidated Framework for Implementation Research (CFIR). METHODS:A mixed-methods analysis was performed of cross-sectional data from a survey distributed by snowball sampling across a global research network. A five-point Likert scale assessed perspectives on safety and feasibility of implementation of reusable textiles. An open-ended question asked about the implementation of reusables. Inductive and deductive coding was used, informed by the CFIR. RESULTS:A total of 5734 responses were collected, of which 5230 were eligible for inclusion. Most respondents believed that the intervention was unlikely or very unlikely to affect safety (3266/5230, 62.4%) or have detrimental consequences on environment or patient care (2990/5230, 57.2%), and that its introduction was likely or very likely to be successful (2888/5230, 55.2%). From a total of 1514 free-text entries, nine unique implementation factors were identified. Financial constraints were important across all settings. Whilst sterilisation-related issues were commonly reported in low and middle-income countries, institutional challenges were prominent in high-income countries. Mapping these factors to CFIR, the 'setting' of the intervention was the most relevant for effective implementation, along with the 'individuals' within the setting, rather than the intervention itself or the implementation process. A strategy identification tool and programme theory were developed, providing a starting point for institutions considering implementation of reusables and basis for future research. CONCLUSION:Implementation of this carbon-reducing intervention varied across resource settings. Recognising the unique implementation context, and developing tailored strategies, could aid implementation of this innovation through both research and wider scale rollout.
OBJECTIVES:In the Fluorouracil, Oxaliplatin and Targeted Receptor pre-Operative Therapy (FOxTROT) trial, neoadjuvant chemotherapy (NAC) significantly reduced recurrence risk, compared to upfront surgery, in locally advanced colon cancer. This analysis evaluates the correlation between radiological and pathological staging within the trial to support the adoption of CT-based patient selection. METHODS:In this preplanned analysis of prospectively collected data, local radiological and pathological staging were compared in upfront surgery participants. T stage, N stage, and extramural venous invasion (EMVI) status were evaluated using overall agreement, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Subgroup analyses explored the impact of mismatch repair status and tumour side. RESULTS:A total of 354 participants were included. T stage agreement was 63.0%; T3 and T4 tumours were correctly identified in 78.9% and 41.1% of participants, respectively. The PPV for T3-4 status was 94.5%. N stage agreement was 39.8%; for N status (positive vs. negative), overall agreement, sensitivity, specificity, PPV, and NPV were 54.1%, 81.1%, 26.0%, 53.2%, and 57.1%, respectively. For EMVI, these values were 54.9%, 71.0%, 41.2%, 50.7%, and 62.5%, respectively. Accuracy metrics did not differ significantly by tumour side or mismatch repair status. CONCLUSIONS:CT effectively predicted T3-4 status with minimal overstaging, but performed poorly for individual T stage, N stage, and EMVI. We propose radiological T3-4 status should be adopted as the primary biomarker for neoadjuvant patient selection, with molecular biomarkers to guide treatment choice. ADVANCES IN KNOWLEDGE:In this multicentre trial, local radiologists accurately identified T3-4 status to select participants for NAC, indicating utility for future neoadjuvant trials and clinical practice.
The increasing prevalence of multiple long-term conditions (MLTC) presents significant challenges to healthcare delivery globally. Although interventions for long-term conditions have predominantly been designed and evaluated in primary care settings, there is a growing recognition of the need to address the management of MLTC within secondary care. This scoping review aims to comprehensively evaluate hospital-initiated complex interventions for people with MLTC. We searched MEDLINE, Embase, PsycINFO, CINAHL Plus and Cochrane Library to identify published studies from Jan 1, 2010, evaluating hospital-initiated interventions initiated for adults (aged ≥ 18 years) with MLTC (PROSPERO: CRD42024498448). Studies reporting patients with frailty only, one long-term condition or orthogeriatric studies that did not focus solely on people with MLTC were excluded. The primary outcome measures were the characteristics of these complex interventions measured as: (i) intervention components, (ii) stakeholders involved; and (iii) implementation strategies, reported according to a theoretical framework (Expert Recommendations for Implementing Change). Secondary outcome measures were clinical and cost implications of these complex interventions, feasibility and sustainability, defined according to the World Health Organisation implementation framework. This scoping review identified 70 studies (56,111 participants). Twelve intervention components were identified in 52 combinations; the most common were medication review and optimisation (n = 39), chronic disease management (n = 34) and providing detailed care plans (n = 23). Majority of studies included two or more interventions components (n = 49) delivered by multiple stakeholders (n = 38). Of eleven implementation strategies reported, training and educating stakeholders, establishing integrated wards or clinics and regular multidisciplinary team meetings were the most common. Majority of combinations of intervention groups were associated with improved clinical outcomes for patients with MLTC (n = 43/70, 61.4
Global health has traditionally focused on the primary health development with disease-specific focus such as HIV, malaria and non-communicable diseases (NCDs). As such, surgery has traditionally been neglected in global health as investment in them is often expensive, relative to these other priorities. Therefore, efforts to improve surgical care have remained on the periphery of initiatives in health system strengthening. However, today, many would argue that global health should focus on universal health coverage with primary health and surgery and perioperative care integrated as a part of this. In this article, we discuss the past developments and future-looking solutions on how surgery can contribute to the delivery of effective and equitable healthcare across the world. These include bidirectional integration of surgical and chronic disease pathways and better understanding financing initiatives. Specifically, we focus on access to safe elective and emergency surgery for NCDs and an integrated approach towards the rising multimorbidity from chronic disease in the population. Underpinning these, data-driven solutions from high-quality research from clinical trials and cohort studies through established surgical research networks are needed. Although challenges will remain around financing, we propose that development of surgical services will strengthen and improve performance of whole health systems and contribute to improvement in population health across the world.