Introduction The purpose of this study was to pilot a new concept for device appraisal—leveraging international real-world data (RWD) from the International Consortium of Vascular Registries (ICVRs) to assess aggregate endovascular aortic repair (EVAR) performance against a conservative performance goal (PG) derived from open surgical repair (OSR), with the intention of helping refine device labelling in collaboration with industry and the US Food and Drug Administration.Research Design and Methods International retrospective, multicentre, single-arm cohort, open-label clinical PG-based study within the ICVRs. Because OSR patients may not have been anatomically EVAR-eligible, the OSR cohort used for PG derivation was restricted to smaller diameters (<6.5 cm men; <5.5 cm women) to include patients eligible for EVAR. Analyses performed at Weill Cornell Medicine (MDEpiNet Center).Results OSR PG cohort: 932 patients (72±9 years average; 83.8% men) with 30% in-hospital mortality. EVAR cohort: 219 patients (75±10 years average, 83.1% men) with larger aneurysms (EVAR 7.3±2.0 cm vs OSR 5.3±1.3 cm; p<0.001). In-hospital mortality after EVAR was 18% (upper 95% CI 13% to 23%), exceeding the PG (p<0.001). EVAR showed lower dialysis (10.6% vs 15.7%; p=0.02), bowel ischaemia (1.8% vs 7.5%; p<0.001) and reoperation for bleeding (2.7% vs 7.1%; p=0.004).Conclusions This proof-of-concept study shows harmonised international RWD can evaluate device performance in ruptured abdominal aortic aneurysm. Despite a comparator biased to favour OSR, EVAR met/exceeded the PG and reduced complications, supporting regulatory discussions to align instructions for use with guideline-endorsed EVAR-first strategies
This systematic review evaluates the impact, usability, technical performance and adherence of telemonitoring systems in adult cancer care. This systematic review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Peer Review of Electronic Search Strategies guideline. PubMed, MEDLINE and CINAHL were searched from June 2013 to March 2025. Search terms covered cancer care, telemonitoring systems, mobile health (mHealth), eHealth, health outcomes and evaluation tools. Included studies were randomised controlled trials, controlled clinical trials or prospective trials involving adult patients with cancer using telemonitoring systems for symptom management. Exclusion criteria included cross-sectional, retrospective or non-English studies. Two reviewers screened and extracted data, with a third reviewer resolving disagreements. Risk of bias was assessed using Cochrane Risk of Bias Tool V.1. Due to heterogeneity, a narrative synthesis was conducted, categorising studies by intervention type, clinical outcomes, adherence and usability. 16 studies were included. Telemonitoring appears to hold potential in oncology care, with indications of improved quality of life, symptom management and patient engagement, particularly when real-time clinician feedback is included. While mHealth apps were well received, asynchronous systems were associated with lower adherence. Few studies addressed data security or long-term outcomes. The search was aligned with European Union (EU) - assigned eHealth for Cancer Prevention & Care (eCAN Joint Action) priorities, which may have narrowed the results and limited the overall completeness of this systematic review. Telemonitoring shows promise in oncology care but requires personalisation, workflow integration and long-term evaluation. Real-time clinician support may enhance adherence and outcomes.PROSPERO registration numberCRD42023430639.
Objectives To perform the first-in-human concomitant robotic liver resection and cone-beam CT (CBCT)-guided ablation in a hybrid operating room (HARMONY). Design IDEAL stage 0/1 study outlining the preparatory steps and outcomes of the first-in-human HARMONY procedure. IDEAL stage 0 involved conceptualisation, team training and dry runs. The first HARMONY procedure was performed and the procedural technique is described in detail. Setting All procedures took place at a single academic medical centre. Participants Patients eligible for the HARMONY procedure are any adults eligible for combined ablation and resection of colorectal liver metastases. The HARMONY procedure was performed in a first patient. Outcomes of patients who underwent sequential robotic liver resection and CT hepatic arteriography-guided liver ablation in the preparatory phase are also reported. Intervention Concomitant robotic liver resection and CBCT-guided ablation in a hybrid operating room. Main outcome measures The primary outcome was technical feasibility of the HARMONY procedure defined as the technical success of both the robotic surgical resection and CBCT-guided ablation within the hybrid operating room. Results Between 2018 and 2024, 19 patients underwent sequential robotic liver resection and CT-guided ablation. Median interval between procedures was 4 days, with 36.8% treated during one admission. Intraoperative incidents occurred in three (15.8%) patients and two (10.5%) patients experienced severe complications requiring reintervention. The first-in-human HARMONY procedure was successfully completed without intraoperative complications. Conclusions The concomitant performance of robotic liver resection and CBCT-guided ablation is technically feasible in a hybrid operating room. Future studies should evaluate its reproducibility, safety and long-term outcomes. Trial registration number CCMO Research with human participants (NL-009169).
Objectives:This systematic review and meta-analysis evaluates the efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing seizure frequency in patients with epilepsy, synthesising evidence from randomised controlled trials (RCTs). Design:Systematic review and meta-analysis of RCTs conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020 guidelines. Setting:Literature search across international (PubMed, EMBASE, Cochrane, Scopus, ScienceDirect, Google Scholar) and Iranian (SID, Magiran, IranMedex) databases. Participants:Adult patients diagnosed with epilepsy, including those with drug-resistant focal epilepsy, from 14 included RCTs (total n=516). Interventions:Active low-frequency rTMS (0.3-1 Hz) compared with sham stimulation or active control (eg, antiepileptic drug therapy). Main outcome measures:The primary outcome was the mean change in weekly seizure frequency analysed using standardised mean difference (SMD). Results:From 1952 retrieved records, 14 RCTs were reviewed and 8 were meta-analysed (n=367). The pooled analysis showed a statistically significant reduction in seizure frequency favouring rTMS (SMD=-0.46, 95% CI -0.57 to -0.34, p=0.001, Z=-7.67), with low heterogeneity (I²=0.1%). The combined mean seizures were 6.1 (intervention) versus 7.4 (control) per week. No significant publication bias was detected (Egger's test p=0.086). Conclusions:Low-frequency rTMS demonstrates a significant short-term reduction in seizure frequency. However, the clinical durability of this effect remains uncertain due to limited follow-up in existing trials. Definitive conclusions require larger, standardised RCTs with longer-term outcomes. Trial registration:No human participants included.
Objective To investigate whether preoperative inflammatory biomarkers have prognostic value in terms of postoperative surgical morbidity in stage I–III resectable colorectal cancer.Design Prospective observational cohort study.Setting This is a single centre study conducted at the general surgery department of Djilali Belkhenchir, formerly Birtraria, Hospital, in Algeria.Participants We enrolled patients with non-metastatic colorectal cancer who underwent initial curative resection from May 2022 to May 2025.Main outcome measure Preoperative inflammatory biomarkers such as neutrophil to lymphocyte ratio, platelets to lymphocyte ratio, monocyte to lymphocyte ratio and lymphocyte×albumin (LA) were calculated based on blood samples taken 30 days prior to surgery. The primary outcome was postoperative morbidity and the secondary outcome was postoperative mortality.Results 230 patients met the inclusion criteria and had curative resection. Multivariable regression analysis showed that tumour size (OR 1.264, 95% CI 1.098 to 1.455, p<0.001), LA (OR 0.501, 95% CI 0.284 to 0.881, p=0.016) and rectal location (OR 2.569, 95% CI 1.138 to 5.798, p=0.023) were independent factors associated with postoperative complications.Conclusion The LA score, tumour size and tumour location were associated with post-operative morbidity in patients with stage I–III resectable colorectal cancer.
Objectives To evaluate the effectiveness of a dual-target deep brain stimulation (DBS) approach, stimulating both the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr), and improvement of gait function and quality of life (QoL) in patients with Parkinson’s disease (PD).Design Systematic review and meta-analysis of crossover randomised controlled trials (RCTs).Setting A systematic search was conducted across PubMed, ScienceDirect and Scopus databases up to October 2025.Participants Adults with advanced PD (disease duration >5 years) experiencing clinically significant and refractory freezing of gait (FoG) despite optimal dopaminergic therapy and standard STN-DBS.Interventions Dual-target DBS stimulation of the STN and SNr compared with conventional STN-only stimulation.Main outcome measures FoG and QoL.Results Eight crossover RCTs (n=97) were included. Combined STN+SNr resulted in a significant reduction in FoG compared with STN stimulation alone (standard mean difference=−0.39 (95% CI −0.73 to −0.04), I2=23.2%). No significant difference was observed in QoL (mean difference=−0.79 (95% CI −1.92 to 0.34), I2=0%). Meta regression revealed high-frequency stimulation in both targets was a significant moderator for gait improvement (95% CI −0.96 to −0.05, I2=39.2%). Adverse effects were generally transient and reversible.Conclusions Combined STN and SNr stimulation provides significant clinical benefit for refractory FoG in advanced PD. However, this motor improvement did not translate into immediate QoL gains. Further investigation of RCTs and integrated rehabilitative management are essential to establish broader applicability and its long-term value.PROSPERO registration number CRD42025632066.
Introduction:The da Vinci robot continues to be the leading robotic system used in surgery. Following the expiry of its patent, many manufacturers started to develop other systems. We accompanied this sensitive initial phase of implementing a new surgical system in a clinic at which the previously established robotic system has completed its learning curve. Is it ethically justifiable to implement a new robotic system although an established, reliable and low-risk procedure is available? Research design and methods:We conducted a longitudinal and interdisciplinary questionnaire study from November 2022 to April 2023. Specific questionnaires - answered on a visual analog scale from 1 to 100 - were created for four target groups: surgeons, anesthesiologists, residents, and operating-room (OR) nurses. Results:A total of 63 participants filled the questionnaire and answered the tailored questions. While the surgeons, along with the OR nurses, initially had the greatest reservations about the Dexter robot and patient safety, their reservations lessened as the number of Dexter procedures performed increased. In contrast, the OR nurses were critical of the new robot and their ratings did not change as the number of Dexter procedures increased. Of all four groups, the residents rated the Dexter robot most positively. Conclusions:The establishment of a new surgical system that has been approved, yet not established so far, constitutes a major challenge with regard to ethical issues concerning patient safety. A standardized, mandatory curriculum for the entire surgical team would be desirable in order to achieve a similar level of technical expertise as that existing for the established robot system. In addition, we need comprehensible and transparent information for patients. To date, we lack regulations concerning these aspects, which are handled differently in the individual hospitals.
Introduction Despite its reasonable pathophysiological basis, peritoneovenous shunt (PVS) implantation currently plays a very limited role in managing patients with refractory ascites. On the other hand, we have 20 years of experience using PVSs. The aim of this study was to evaluate the clinical efficacy and long-term outcomes of PVS implantation for the treatment of refractory ascites caused by alcoholic liver cirrhosis.Methods We conducted a retrospective review of 348 consecutive patients who underwent PVS placement. Survival data were compared in subgroups according to: (1) severity of liver cirrhosis; (2) occurrence of shunt occlusion; and (3) patients who had contraindications for liver transplantation (LT).Results The 1-year and 5-year survival rates for the entire study population were 63% and 23%, respectively. In the shunt occlusion group, the survival rate was comparable with that of the control group: 1-year survival rate was 73%, and 5-year survival rate was 26%. In the strictly selected population where LT was contraindicated, the 1-year and 5-year survival rates were 53% and 20%, respectively.Conclusion For a well-selected group of patients, PVS implantation is a favorable choice. However, long-term survival data do not justify the highly restricted role of PVS in treatment guidelines.
INTRODUCTIONPostoperative complications (PCs) rates are crucial quality metrics in surgery, as they reflect both patient outcomes, perioperative care effectiveness and healthcare resource strain. Despite their importance, efficient, accurate and affordable methods for tracking PCs are lacking. This study aimed to evaluate whether natural language processing (NLP) models could detect 11 PCs from surgical electronic health records at a level comparable to human curation.RESEARCH AND DESIGN METHODSRetrospective study in 18 hospitals across two regions in Denmark. A total of 17 486 surgical cases spanning 6 years were included. The dataset was divided into training, validation and test sets for NLP-model development and evaluation (50.2%/33.6%/16.2%). Model performance was compared against the current method of PC monitoring (International Classification of Diseases, 10th Revision (ICD-10) codes) and manual curation, the latter serving as the gold standard.17 486 surgical cases from spanning 6 years were included. The dataset was divided into training, validation and test sets for NLP-model development and evaluation (50.2%/33.6%/16.2%). Model performance was compared against the current method of PC monitoring (International Classification of Diseases, 10th Revision (ICD-10) codes) and manual curation, the latter serving as the gold standard.RESULTSThe NLP-models had a receiver operating characteristic area under the curve between 0.901 and 0.999 for the test set and significantly outperformed ICD-10 coding in detecting PCs. Sensitivity of the models when compared with manual curation ranged from 0.701 to 1.00, except for myocardial infarction (0.500). Positive predictive value (PPV) ranged from 0.0165 to 0.947, and negative predictive value from 0.995 to 1.00. Using a Human-in-the-Loop approach, only 16.3% of cases required manual review to reach a PPV of 1.00.CONCLUSIONSThe NLP models alone were able to detect PCs at an acceptable level and outperformed ICD-10 codes. While combining NLP with manual review (Human-in-the-Loop) improved overall accuracy and reduced workload, the models still failed to identify some complications. Therefore, NLP algorithms may support (but not replace) manual surveillance and present a potential solution for more scalable PC monitoring.
Objectives Medical device registries in Europe report limited information about their structure and methodological characteristics. This hinders their utility for evaluation of medical device safety and performance under the Medical Device Regulation. This study aimed to define a minimum checklist of items necessary for regulators to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.Design A three-round Delphi panel.Setting A task within the Coordinating Research and Evidence for Medical Devices project.Participants 101 experts in the medical device community (healthcare professionals, methodologists, registry experts, regulators, and assessors from notified bodies) were invited.Interventions Based on a literature review and expert advice, 27 items relating to the quality of registry data and the analysis of medical device safety and performance were selected. In round 1, participants selected which items were required for a minimum checklist. They could also propose new items. Items selected by ≥70% of participants indicated consensus. Remaining items were discussed in round 2, resulting in a final checklist that was ranked by participants for importance (round 3).Main outcome measures Consensus of items to be included in the minimum checklist.Results 51 experts participated in round 1, achieving consensus on 18 (67%) items and suggesting 12 items. After discussion in round 2, 5 additional items were selected, resulting in a final set of 15 data quality items and 8 data analysis items. The most important items were ‘completeness of procedures’ (data quality) and ‘definition of outcome analyzed’” (quality of analysis).Conclusions Reporting all items from the minimum checklist will facilitate judgment of the utility of registry data to evaluate medical devices during post-market surveillance.
Objectives:Patients with type 2 diabetes mellitus (T2DM) are associated with a higher risk of carotid artery stenosis and adverse postoperative outcomes compared with individuals without T2DM. The comparative effectiveness after carotid endarterectomy (CEA) versus carotid artery stenting (CAS) in this population remains unclear. This study aimed to compare the in-hospital outcomes of CEA versus CAS in patients with carotid artery stenosis and T2DM. Design:A retrospective cohort study using a doubly robust estimation model which incorporated an inverse probability weighting (IPW) model, followed by logistic regression to balance baseline characteristics. Setting:Nation-wide administrative hospitalizations in the US National Inpatient Sample, 2016-2021. Participants:Adults (≥18 years) with T2DM who underwent either CEA or CAS for asymptomatic or symptomatic carotid stenosis. Main outcome measures:In-hospital mortality, postoperative stroke and myocardial infarction during the same admission. Results:A total of 31,363 patients with asymptomatic carotid stenosis (CAS, n=6338; CEA, n=25,025) and 3710 patients with symptomatic carotid stenosis (CAS, n=1271; CEA, n=2439) were evaluated. Among asymptomatic patients, the CEA group had a lower risk of mortality (108 (0.4%) vs 58 (0.9%); adjusted OR 0.997, 95% CI 0.995 to 0.999) but a higher incidence of myocardial infarction (500 (2.0%) vs 151 (2.4%); adjusted OR (aOR) 1.005, 95% CI 1.001 to 1.008) compared with the CAS group. No significant difference in the incidence of postoperative stroke was observed. Among symptomatic patients, the CEA group was also associated with a lower risk of mortality (29 (1.2%) vs 56 (4.4%); aOR 0.973, 95% CI 0.961 to 0.985), with no significant differences in postoperative stroke or myocardial infarction. Conclusions:CEA was associated with lower in-hospital mortality in type 2 diabetic patients with symptomatic or asymptomatic carotid stenosis compared with CAS, but its use in asymptomatic individuals should be carefully considered due to potential cardiovascular risks.
Objectives Reporting standards for adverse events (AEs) in arthroscopic rotator cuff repair (ARCR) vary. A standardized “core event set” (CES) was developed to enhance AE documentation. This study describes AE risks in a large Swiss-German ARCR cohort, evaluates concordance between patient-reported and clinician-reported events, and investigates AE variability according to tear severity.Design Prospective multicenter cohort study.Setting Between June 2020 and November 2021, 973 patients were enrolled across 19 orthopedic centers and followed for 24 months.Participants Adult patients with a rotator cuff tear.Interventions Primary ARCR.Main outcome measures AEs were documented using a structured CES and classified into five severity grades. AE reporting was compared between patients and clinical staff. AE cumulative risks (CR) were calculated by occurrence period, severity grade, and tear severity.Results A total of 342 AEs were documented in 314 patients within 2 years. Of these, 41% were reported only by clinical staff, 40% only by patients, and 19% by both. The 2-year CR of AEs was 29.1%, with persistent pain (12.2%) and deep soft tissue complications (10.6%) being most common. Severity classification revealed 61.7% grade I, 24.3% grade II, 13.2% grade III, and 0.9% grade IV. Tear severity was inversely associated with overall AE risk, ranging from 41.5% in partial tears to 28% in massive tears.Conclusions Standardized AE documentation using CES identified pain, deep soft tissue complications, and rotator cuff issues as the most frequent local AEs. Both clinicians and patients should be involved in AE reporting. Most AEs were mild, and tear severity predicted AE risk, highlighting the need for tailored postoperative strategies and further research on preventive measures.
Objectives:To study the cost-effectiveness of additional intra-arterial thrombolysis (IA lysis) after successful recanalization with endovascular thrombectomy (EVT). Design:A cost-effectiveness model was used to estimate both direct medical costs and quality-adjusted life years (QALYs) gained in six European countries (Spain, the Netherlands, Italy, the United Kingdom, France, Germany) and the USA. Setting:The model was based on published data from those countries on health economics. Participants:Cost of procedure as well as acute, mid-term and long-term care costs were estimated based on expected modified Rankin Scale (mRS) scores as reported in the Chemical Optimization of Cerebral Embolectomy (CHOICE) trial, which reported improved neurological outcomes after adjunctive IA lysis following EVT. Main outcome measures:QALYs in the model were calculated by mapping mRS outcomes from the CHOICE trial to EQ-5D utility values from a validated poststroke cohort, projecting these over a 20-year lifetime horizon with 3% annual discounting, assuming health state transitions only after recurrent stroke (always to a worse mRS) and no recurrent stroke risk in the first 90 days. Results:IA lysis was found to be a cost-effective option in seven different countries (Spain, the Netherlands, Italy, the United Kingdom, France, Germany and the USA). We found an incremental cost-effectiveness ratio ranging from US$-2350 per QALY gained in Germany to US$9628 per QALY gained in the USA. A cost-effectiveness acceptability curve showed 90% acceptability of IA lysis at the willingness to pay varying between US$10 000 and US$45 000 depending on the country. Conclusions:IA lysis after successful EVT was cost-efficient after reperfusion in the seven countries studied. The early termination, small sample and limited power of the CHOICE trial reduce generalizability of our results. Larger trials are needed to confirm cost-effectiveness of IA lysis after successful EVT.
Objective This study aimed to review the impact of bone conduction hearing implants (BCHIs) surgery on patients’ quality of life (QoL) across general, physical, social and overall well-being domains.Design A prospective correlational study.Setting Single tertiary referral center in the UK.Participants All adult patients undergoing their first BCHI over a 10-year and 6-month period (between June 1, 2012, and December 31, 2022). A total of 163 were included out of 195 potentially eligible participants.Main outcome measure The Glasgow Health Status Inventory (GHSI) was used to assess patients’ QoL pre and post BCHI surgery.Results BCHI surgery showed significant improvements across all GHSI QoL domains; total (p<0.0001), general (p<0.0001), social (p<0.0001) and physical (p<0.0001).Conclusion The largest of its kind, this study recognizes the wide-reaching impact of BCHIs on patients’ QoL, evidencing them as a highly effective and life-improving surgical intervention.
Objectives To compare the long-term outcomes of initial thoracic endovascular aortic repair (TEVAR) versus initial medical therapy (iMT) in patients with acute uncomplicated type B aortic dissection (uTBAD), using real-world evidence from a nationwide claims database in Japan. This study aligns with stage 4 of the Idea, Development, Exploration, Assessment, and Long-term Study (IDEAL) framework for surgical innovation.Design A retrospective cohort study using propensity score matching (PSM) to balance baseline characteristics.Setting Japanese nationwide health insurance claims database, between 1 January 2015 and 31 December 2023.Participants Among 40 229 cases with tentative codes for aortic dissection (International Classification of Diseases-10: I71.0), 4995 met all eligibility criteria for acute uTBAD. Among these patients, 96 underwent TEVAR in the subacute phase (15–90 days post diagnosis), while 4899 were managed with iMT. After PSM, 96 TEVAR cases were matched to 480 iMT cases in a 1:5 ratio.Main outcome measures The primary outcomes were aorta-related events and all-cause mortality. The secondary outcome was the frequency of follow-up CT imaging every year.Results After PSM, the baseline characteristics of both groups were balanced. Median age was 56 years (IQR: 50–62 years) in both groups, and follow-up duration was similar (TEVAR: 31 months; iMT: 28 months, p=0.84).At 60 months, Kaplan-Meier estimates showed an aorta-related event rate of 21.9% (95% CI: 12.6% to 36.4%) for TEVAR and 19.9% (95% CI: 15.6% to 25.2%) for iMT (p=0.99).All-cause mortality was 4.4% (95% CI: 1.4% to 13.6%) for TEVAR and 6.6% (95% CI: 4.0% to 10.6%) for iMT (p=0.70). No significant differences were observed.Conclusions While aorta-related events accumulated steadily in the crude iMT group, no survival benefit was observed for subacute TEVAR. These findings support ongoing randomized controlled trials and show the utility of claims-based analyses in IDEAL Stage 4.
The Society of Cardiothoracic Surgery (SCTS) in Great Britain and Ireland provides comprehensive guidelines for the management of adult mitral valve disease, addressing both surgical and transcatheter interventions. These guidelines serve as a resource for healthcare professionals, supplementing existing clinical guidelines. They emphasize the evolving complexity of mitral valve disease management, influenced by the development of new technologies, ongoing research, and randomized trials.The guidelines detail a thorough methodology, incorporating an extensive literature review and evidence assessment conducted by a clinical guidelines team. They outline best practices of preinterventional patient assessment and indications of mitral interventions, while considering the management of patient comorbidities and concomitant diseases. Detailed repair techniques for mitral regurgitation and rheumatic valve disease are provided, along with a summary of indications for emerging transcatheter and hybrid procedures, including transcatheter edge-to-edge repair, transapical neo-chordee placement, transcatheter aortic valve mitral implantation, and percutaneous mitral annuloplasty. The guidelines address postoperative mitral complications and prosthesis considerations, including up-to-date recommendations for antithrombotic management.These guidelines aim to improve patient outcomes through detailed, evidence-based recommendations and encourage the development of specialized mitral MDTs within UK practice. They provide an educational resource, clarifying the implementation of recent technologies and supporting clinical decision-making in the management of adult mitral valve disease.
Objectives This study aimed to assess the surgical quality, safety, and healthcare utilization associated with gastric cancer surgery in China, using international studies for benchmarking.Design A prospective registered study was conducted utilizing data from the Prevalence of Abdominal Complications After Gastroenterological Surgery study, comprised of 1859 patients without postoperative complications (non-POC group) and 412 patients with at least one POC group. Baseline characteristics, surgical outcomes, and healthcare utilization were compared between groups, and results were further contextualized through a review of international multicenter studies.Setting 20 centers across China, with data collected from December 2018 to December 2020.Participants 2271 patients who underwent gastrectomy for gastric cancer, including 1859 in the non-POC group and 412 in the POC group.Main outcome measures POC incidence, postoperative hospital stay, healthcare costs, and cross-regional comparisons of surgical quality.Results Patients with POCs exhibited distinct baseline and intraoperative profiles compared with those without. The most frequent complications were respiratory infections, anastomotic leakage, and non-leak intra-abdominal infections. Among surgical types, proximal gastrectomy had the highest POC incidence. Costs and postoperative hospital stay were significantly higher in patients with these complications. Compared with international cohorts, China demonstrated comparable surgical quality and complication profiles. However, the cost burden associated with major POCs was substantially lower in China, despite similar hospital stays.Conclusion China’s gastric cancer surgery outcomes align with international standards in terms of surgical quality and complication rates. Notably, major complications were associated with significantly lower costs than those reported internationally, suggesting greater cost advantages in postoperative management. These findings highlight the value of robust complication reporting systems and evidence-based management protocols in delivering cost-effective, high-quality surgical care.Trial registration number NCT03828266.
Objectives:To evaluate the influence of femtosecond laser-assisted cataract surgery (FLACS) on the post-operative capsular bag and visual performance using a novel aspheric hydrophobic intraocular lens (IOL). Design:Randomized controlled bilateral study. Setting:Department of Ophthalmology and Optometry, Kepler University Hospital, Linz, Austria. Participants:Patients scheduled for bilateral cataract surgery. Interventions:Patients were scheduled either for conventional cataract surgery or femtolaser-assisted cataract surgery. Main outcome measures:Anterior chamber depth, IOL tilt, IOL decentration, best-corrected distance visual acuity, uncorrected distance visual acuity. Results:In total, 100 eyes of 50 patients were included in this study. After 6 months, there was no relevant difference between the FLACS and the conventional cataract group regarding anterior chamber depth (4.56±1.68 mm and 4.60±0.26 mm; p=0.903), tilt (4.87°±2.17° and 4.37°±1.62°; p=0.124) or decentration (0.28±0.14 mm and 0.33±0.20 mm; p=0.414), respectively. The postoperative mean spherical equivalent showed a slight hyperopic shift with no relevant difference between both groups (+0.17±0.49 D and +0.19±0.50 D; p=0.996) with a target refraction of emmetropia or myopia (-2.5 D). Conclusions:FLACS was not superior to manual cataract surgery regarding capsular bag or visual performance, and the investigated IOL was safe and stable. Trial registration number:NCT06069752.
ABSTRACT: Background:In France, 25% of healthcare emissions are attributed to the supply of medical devices, underscoring the necessity for the development of more sustainable procurement policies. However, comparing the carbon footprint of different devices, especially single-use devices versus reusable ones, presents challenges. Objective:To assess the carbon footprint of single-use and reusable electrosurgical scalpels over 1 year of use in our hospital setting. Design:A cradle-to-grave analysis was conducted from May 1, 2022, to April 30, 2023. Setting:Nantes University Hospital, France. Main outcome measures:The study quantifies carbon emissions across all life cycle stages: raw material extraction, manufacturing, transportation, use, maintenance, and disposal. For reusable devices, sterilization emissions were allocated based on the total annual workload of the Central Sterile Services Department. Carbon footprint values were derived from direct measurements, manufacturer and supplier data, and literature, with conversions using a public and national database (Base Empreinte, ADEME). Results:The carbon footprint of single-use devices was estimated at 4291 kg of carbon dioxide equivalent (CO2e), with 94% attributed to the production of the device itself. The carbon footprint related to the reusable device was estimated at 494 kg CO2e, with 86% stemming from handling at our sterilization unit. Conclusions:These findings are contingent on our hospital's practices and may vary based on several factors. Beyond estimating these carbon footprints, it provides a practical, decision-oriented analysis accessible for hospital leadership and healthcare professionals, supporting institutional change.
