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Compliance with antimicrobial stewardship guidelines in surgery: an observational, multidisciplinary, cohort study
International audiencePurpose: Antimicrobial stewardship aims to improve clinical outcomes while reducing the unintended effects of antimicrobial use. The use of antibiotics in surgical wards, except for surgical antibiotic prophylaxis, has been poorly documented. Our goal was to assess the rate of compliance with the guidelines of antibiotic prescriptions in surgical wards.Method: In a single academic center, a retrospective analysis was conducted over a two-month period to assess the rate of compliance with four criteria reflecting good practice in terms of antimicrobial stewardship: (1) decision of treatment initiation in line with the guidelines, (2) adequate spectrum of antibiotics in terms of patient characteristics; (3) duration of antibiotic treatment in compliance with the guidelines, and (4) whether re-adaptation of treatment was required. Positive responses to these four criteria indicated a 100% compliance rate. A pair of experts assessed the clinical vignettes to decide the compliance of each criterion. The secondary aims were to assess whether a 100% compliance rate was associated with positive outcomes.Results: Among the 1,339 single stays in surgical wards, 232 patients (17%) received antibiotics during the study period. The rate of compliance with all four criteria was 33%. In addition, 149 (64%) patients complied with indication and spectrum, and 91 (39%) patients complied with indication, spectrum, and duration. Compliance with the antimicrobial treatment was associated with improved outcomes.Conclusion: Of the patients hospitalized in the surgical wards, antimicrobial stewardship guidelines were complied with in 33% patients. Full compliance with the guidelines was associated with improved outcomes
Landmark-free Automatic Digital Twin Registration in Robot-assisted Partial Nephrectomy using a Generic End-to-end Model
International audiencePurpose. Augmented Reality in Minimally-Invasive Surgery has made tremendous progress in organs including the liver and the uterus. The core problem of Augmented Reality is registration, where a preoperative patient's geometric digital twin must be aligned with the image of the surgical camera. The case of the kidney is yet unresolved, owing to the absence of anatomical landmarks visible in both the patient's digital twin and the surgical images. Methods. We propose a landmark-free approach to registration, which is particularly well-adapted to the kidney. The approach involves a generic kidney model and an end-to-end neural network, which we train with a proposed dataset to regress the registration directly from a surgical RGB image. Results. Experimental evaluation across four clinical cases demonstrate strong concordance with expert-labelled registration, despite anatomical and motion variability. The proposed method achieved an average tumour contour alignment error of 7.3 ± 4.1 mm in 9.4 ± 0.2 ms. Conclusion. This landmark-free registration approach meets the accuracy, speed 1 and resource constraints required in clinical practice, making it a promising tool for Augmented Reality-assisted Partial Nephrectomy
Efficacy and Safety of Infliximab and Vedolizumab Maintenance Therapy in Patients with Crohn’s Disease and Ulcerative Colitis: A Systematic Review and Meta-Analysis
International audienceBackground/Objectives: Direct comparative data for infliximab and vedolizumab are limited due to lack of head-to-head trials. This systematic review and meta-analysis compared the efficacy and safety of infliximab and vedolizumab as intravenous or subcutaneous maintenance treatments for adults with moderately to severely active Crohn’s disease or ulcerative colitis. Methods: Medical databases, PubMed, Embase, and the Cochrane Library were systematically searched from January 2010 to May 2024 to identify Phase 1 to 3 randomized controlled trials. The primary and co-primary outcomes were the proportions of patients achieving clinical remission and clinical response at one year, respectively. Safety was also analyzed (PROSPERO CRD42023483599). Data for each outcome were pooled using a two-sided random-effects model in separate analyses for Crohn’s disease and ulcerative colitis. Results: Seven eligible Crohn’s disease trials and eight eligible ulcerative colitis trials contributed data for 1910 and 2372 patients, respectively. For Crohn’s disease, higher proportions of infliximab-treated patients achieved clinical remission (0.64 [95% confidence interval: 0.60–0.68]) and/or clinical response (0.71 [0.67–0.75]) at one year compared with vedolizumab-treated patients (0.40 [0.35–0.46] and 0.47 [0.43–0.51], respectively). For ulcerative colitis, similar proportions of infliximab- and vedolizumab-treated patients achieved clinical remission (0.54 [0.38–0.71] vs. 0.40 [0.35–0.44]) and/or clinical response (0.52 [0.45–0.58] vs. 0.58 [0.51–0.65]) at one year. Safety results showed no significant differences. Conclusions: An indirect comparison of maintenance treatment with infliximab and vedolizumab demonstrated that infliximab yields significantly better efficacy than vedolizumab in Crohn’s disease, whereas both agents yielded similar efficacy in ulcerative colitis
Multicentre, double-blind, randomised controlled clinical trial comparing intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: the PROPHYLOXITIN study protocol
International audienceIntroduction Surgical site infections (SSIs) are the second leading cause of healthcare-associated infections in Europe with the highest rates being reported in colorectal surgery (ranging from 9% to 30%). Surgical antibiotic prophylaxis (SAP) is one of the most efficient measures for SSI prevention and should be started before surgical incision. Cefoxitin is an antibiotic widely used as SAP for colorectal surgery, but its continuous administration is currently the subject of debate due to its potential pharmacokinetic advantages. Therefore, the aim of the PROPHYLOXITIN study is to demonstrate that a loading dose followed by continuous infusion of cefoxitin during colorectal surgery (intervention group) decreases the rate of SSI compared to an intermittent bolus administration (control group).Methods and analysis The PROPHYLOXITIN study is a superiority, prospective, double-blind, randomised and multicentre study of 2000 patients undergoing colorectal surgery. The primary objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over intermittent bolus administration in reducing the proportion of SSIs within 30 days after colorectal surgery. Subjects will be randomised 1:1 using a secure web-based random-number generator to one of two study groups. Randomised allocation of treatment will be done by minimisation and stratified according to the centre, the localisation of surgery (colon or rectum) and the type of surgical procedure (laparoscopy or laparotomy).Ethics and dissemination This research has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration number EudraCT 2022-003262-20 and Clinical trial NCT05755789
Influence of statistical approaches on probabilistic sweet spots computation in deep brain stimulation for severe Essential tremor
ACLInternational audienceDeep Brain Stimulation (DBS) is an established therapy for movement and neuropsychiatric disorders. Identifying brain regions (Probabilistic Sweet Spots, PSS) linked with the greatest symptom improvement is crucial for refining pre-operative targeting and post-operative programming. Probabilistic stimulation mapping is a powerful data-driven tool to delineate these regions. However, the chosen statistical methods can influence the identified PSS. A comprehensive evaluation of their impact is lacking in DBS research. The present study compares the PSS generated with four voxel-wise statistical approaches — t-test, Wilcoxon test, Linear Mixed Model, and Bayesian t-test — with the aim of assessing their influence on computed results on the same dataset. Intra-operative stimulation test data of 23 ET patients was used to run patient-specific electric field simulations and to generate PSS in a group-specific anatomical template space. The PSS for the different statistical tests were first compared in terms of size and topography. Then, their correlation with clinical improvement was calculated in a leave-one-out cross-validation scheme and PSS consistency across datasets with different compositions was assessed. Our findings emphasize the impact of statistical test selection on both the anatomical location and volume of the extracted PSS, highlighting the importance of careful methodological choices in future DBS mapping studies. The Bayesian t-test and a voxel-wise application of nonparametric permutation testing, introduced for the first time in DBS research, showed promising results in identifying PSS representative of improvement and exhibited robustness to variations in the dataset
Innovative Trajectory Analysis Reveals Dynamics and Risk Factors of Post‐Kidney Transplant Diabetes Mellitus in a French Cohort
International audienceBackground and Hypothesis Post‐transplant diabetes mellitus (PTDM) is a common, dynamic complication after kidney transplantation (KT) that may resolve over time. To better understand and prevent PTDM, we analyzed its prevalence, evolution, and influencing factors. Methods Data from the French national ASTRE database at different post‐transplantation periods (P) were analyzed. PTDM was defined by fasting blood glucose (FBG) ≥1.26 g/L, HbA1c ≥ 6.5%, or the use of hypoglycemic medications in kidney transplant recipients without diabetes. Patient trajectories were identified using group‐based trajectory models (GBTM), and associated factors were examined. Results Among 2898 patients, PTDM prevalence was 27.3% at P1 (>M2, ≤M6), 21.3% at P2 (>M6, ≤M18), 19.8% at P3 (>M18, ≤M30), and 19.9% at P4 (>M30, ≤M42). Analysis of 1825 patients identified four trajectories: no PTDM (67%), late‐onset PTDM (6%), remission after P1 (10%), and early, persistent PTDM (17%). Late‐onset PTDM was linked to history of cardiovascular disease, higher BMI at transplantation, HCV positive status, and weight gain. Early, persistent PTDM was associated with older age, higher BMI, HVC positive status, history of cardiovascular disease, and tacrolimus use. PTDM remission was linked to lower BMI. Corticosteroids contributed to both late‐onset and persistent PTDM, while switching between tacrolimus and cyclosporine did not significantly affect progression. Conclusion This study confirmed the high prevalence and dynamic nature of PTDM after transplantation, emphasizing the critical role of pretransplant cardiovascular disease, BMI, and early post‐transplant weight gain in the onset or remission of PTDM
La santé du sommeil comme marqueur et cible d’intervention dans les troubles psychiatriques
International audiencePsychiatric disorders (schizophrenia disorder, bipolar disorder, major depressive disorder, autism spectrum disorder) are characterized by complaints of insomnia or hypersomnolence associated with sleep disorder (e.g. obstructive sleep apnea syndrome) or an inappropriate sleep behavior (e.g. irregular sleep-wake cycle). These complaints, disorders, and behaviors define sleep health, a new public health concept that includes six dimensions: duration, regularity, temporality, efficiency, sleep satisfaction and daytime alertness. Sleep health is often impaired in psychiatric disorders, with numerous genetic, biological, anatomical and psychological arguments underpinning this interaction. Interventions aimed at improving sleep health show efficacy on the symptomatology and prognosis of these psychiatric disorders. The aim of this review is to analyze the place of sleep health as a marker and preferred therapeutic target of health in psychiatric disorders. The impact on more general mental health are not addressed.Les altérations du sommeil sont fréquentes et retentissent sur la qualité de vie des patients ayant des troubles psychiatriques. Elles peuvent être caractérisées par une plainte d’insomnie ou d’hypersomnolence, liée à un trouble du sommeil (exemple : syndrome d’apnées obstructives du sommeil), ou à un comportement de sommeil inapproprié (exemple : rythme veille-sommeil irrégulier). Ces plaintes, troubles et comportements définissent la santé du sommeil, un concept récent de santé publique qui possède six dimensions : la durée, la régularité, la temporalité, l’efficacité, la satisfaction du sommeil, et la vigilance pendant la journée. La santé du sommeil est fréquemment altérée dans les troubles psychiatriques ; de nombreux arguments génétiques, biologiques, anatomiques et psychologiques sous-tendent cette interaction. Les interventions visant à améliorer la santé du sommeil montrent une efficacité sur les symptômes et le pronostic de ces troubles psychiatriques. Cette revue a pour objectif d’analyser la place de la santé du sommeil comme marqueur et cible thérapeutique privilégiée dans les troubles psychiatriques. L’impact sur la santé mentale plus générale ne sera pas abordé
DOP042 Bowel damage and its correlation with the disability index in patients with recently diagnosed Crohn´s disease
Meeting abstract du "20th Congress of ECCO", Berlin, Germany, February 19-22, 2025International audienceBackground Crohn’s disease (CD) progression manifests as bowel damage (BD) and disability; prevention of both is a long-term treatment target in CD. However, the longitudinal characterization of BD and disability in early CD patients remains limited. Methods The Crohn´s Disease Cohort (CROCO) is a multicentre, European cohort study of recently diagnosed CD patients (<12 months following diagnosis) designed to prospectively characterize BD progression and disability. At one year following diagnosis (Y1), BD progression was evaluated using the Lemann Index (LI). Magnetic resonance enterography was completed by all patients, with additional endoscopy and/or pelvic MRI based on disease location. Absence of BD was defined as a LI=0, and any presence of bowel damage was indicated by LI>0. Disability was assessed using the validated IBD-disability index (IBD-DI). We report the LI and its association with prognostic disease features and with IBD-DI at Y1. Results Among 394 included patients, 277 completed Y1 visit; LI could be calculated in 176 [60% male, median age at diagnosis 36.5Y (IQR 25-50)]. Most patients (92%) had ileal or ileocolonic involvement, 68% had inflammatory phenotype, and 11% had perianal disease at diagnosis. At inclusion, 6.2% had undergone surgery (5.1% intestinal and 1.1% perianal). Within the 1st year of disease 66% started advanced therapy, mostly Anti-TNF (59%). By Y1, 68% of the patients exhibited some degree of BD (LI>0), yet the median LI at Y1 was low [0.6 (IQR 0-1.8)]. Univariate analysis revealed an association between the presence of any BD at Y1 and disease location (L2 vs L1 OR: 0.37, 95% CI 0.11-1.22, and L3 vs L1 OR 0.59, 95% CI 0.29-1.18, p= 0.044), disease behaviour (B2/B3 vs B1 OR 8.35, 95% CI 3.11-22.38 p<0.01), and steroids (OR 0.48, 95% CI 0.24-0.97), p= 0.036). In a multivariate logistic model, only disease behaviour at Y1 was significantly associated with any BD (B2/B3 vs B1, aOR 7.61, 95% CI 2.79-20.71)-Table 1. The median IBD-DI in those who completed BD assessment at Y1 was 19.6 [10.4;35.7]; 29% of patients had moderate to severe disability (IBD-DI> 35). No association was observed between LI and IBD-DI at Y1 (OR 0.99, 95%CI 0.97-1.02, p=0.60) and there were no differences in the median LI across disability categories. Fig1 shows the correlation between LI and IBD-DI at Y1. Conclusion In a cohort of newly diagnosed CD patients, approximately one-third exhibited no BD as per the LI evaluation. For those presenting with any degree of BD, the global LI remained low. Complicated disease behaviour was the only factor associated with BD. No association was found with disability assessed by the IBD-DI. Prospective follow-up will determine factors underlying BD variation over time
Secondary progression activity monitoring in MS despite an early highly active treatment the SPAM study
International audienceBackground: Real-world data suggest that the early use of highly active therapies (HAT) may reduce the risk of transition to secondary progressive MS (SPMS). However, current knowledge about predictive factors of outcomes needs to be improved. The primary objective of this study was to determine factors associated with the occurrence of SPMS in patients treated early after MS onset with an HAT.Methods: Retrospective, multicentric study based on the French MS database. Patients who initiated a HAT within 5 years after MS onset, EDSS ⩽4, and had a follow-up >5 years were included. The association of each covariate at baseline with time to the occurrence of SPMS was quantified by hazard ratios (HRs) in unadjusted and adjusted Cox proportional hazards models.Results: Two thousand two hundred and thirty-seven patients were included in the analysis: mean age 31.6 years, female/male sex ratio 2.3, and median EDSS 2.0. The estimated probability of reaching SPMS, progression independent of relapse activity (PIRA) and progression independent of activity (PIA) at 10 years was 8%, 22%, and 11%, respectively. After adjustment, we found that female patients (HR 0.64, p = 0.036) had a lower risk of developing SPMS. Older age, EDSS >0 (HR 7.44, p < 0.001), and oral versus intravenous HAT (HR 1.97, p = 0.003) were significantly associated with an increased SPMS risk. Early PIRA and PIA predicted conversion to SPMS.Conclusions: Early HAT use resulted in a low risk of developing SPMS over 10 years. Introducing the HAT before any residual disability was associated with a lower risk of progression
Clinical features and comorbidities associated with migraine in bipolar disorder: Results from the FACE-BD cohort
International audienceIntroduction: Individuals with bipolar disorder (BD) frequently experience comorbid medical conditions, with migraine being among the most common. While research on migraine prevalence in BD is growing, the associated clinical features, comorbidities, and treatments remain underexplored and sometimes inconsistent. This study aimed to investigate the clinical features and comorbidities associated with migraine in a large cohort of adults with BD.Methods: We assessed 4348 outpatients with BD attending FondaMental Advanced Centers of Expertise. Sociodemographic and clinical data were collected using a standardized procedure. Lifetime diagnoses for medical disorders, including migraine, were based on self-reports, clinician assessments, and medical history reviews. Multivariable logistic regression was used to assess associations between migraine and sociodemographic factors, clinical characteristics, comorbidities, and medications.Results: The prevalence of comorbid migraine in BD was 20 %, with 29.1 % in BD type II and 19.9 % in BD type I. Multivariable analysis found that migraine was associated with younger age (OR = 0.98, CI 95 % 0.97-0.99), females (OR = 2.15, CI 95 % 1.56-2.95), sleep disturbances (OR = 1.06, CI 95 % 1.02-1.11), childhood trauma (OR = 1.01, CI 95 % 1.00-1.02), hypertension (OR = 1.88, CI 95 % 1.13-3.15), psoriasis (OR = 1.61, CI 95 % 1.01-2.56), asthma (OR = 1.65, CI 95 % 1.02-2.67) and lower use of second-generation antipsychotics (OR = 0.65, CI 95 % 0.48-0.87).Conclusion: Migraine is common in BD, especially in younger individuals, females, and those with sleep disturbances or a history of trauma, who also experience a higher clinical burden. These overlapping factors highlight the need for an integrated treatment approach, addressing mood stabilization, sleep management, and trauma support to reduce migraine burden in BD patients