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Summary Background Cataract surgery is one of the most common operations in health care. Femtosecond laser-assisted cataract surgery (FLACS) enables more precise ocular incisions and lens fragmentation than does phacoemulsification cataract surgery (PCS). We hypothesised that FLACS might improve outcomes in cataract surgery compared with PCS despite having higher costs. Methods We did a participant-masked randomised superiority clinical trial comparing FLACS and PCS in two parallel groups (permuted block randomisation stratified on centres via a centralised web-based application, allocation ratio 1:1, block size of 2 or 4 for unilateral cases and 2 or 6 for bilateral cases). Five French University Hospitals enrolled consecutive patients aged 22 years or older who were eligible for unilateral or bilateral cataract surgery. Participants, outcome assessors, and technicians carrying out examinations were masked to the surgical treatment allocation until the last follow-up visit and a sham laser procedure was set up for participants randomly assigned to the PCS arm. The primary clinical endpoint was the success rate of surgery, defined as a composite of four outcomes at a 3-month postoperative visit: absence of severe perioperative complication, a best-corrected visual acuity (BCVA) of 0·0 LogMAR (logarithm of the minimum angle of resolution) or better, an absolute refractive error of 0·75 dioptres or less, and unchanged postoperative corneal astigmatism power (≤0·5 dioptres) and axis (≤20°). The primary economic endpoint was the incremental cost per additional patient who had treatment success at 3 months. Primary outcomes were assessed in all randomly assigned patients who met all eligibility criteria (missing data considered as failure). We used mixed logistic regression models or mixed linear regression models for statistical comparisons, adjusted on centres and whether cataract surgery was bilateral or unilateral. The study is registered with ClinicalTrials.gov , NCT01982006 . Findings Of the 907 patients (1476 eyes) randomly assigned between Oct 9, 2013, and Oct 30, 2015, 870 (704 eyes in FLACS group and 685 eyes in the PCS group) were analysed. We identified no significant difference in the success rate of surgery between the FLACS and PCS groups (FLACS: 41·1% [289 eyes]; PCS: 43·6% [299 eyes]); adjusted odds ratio 0·85, 95% CI 0·64–1·12, p=0·250). The incremental cost-effectiveness ratio was €10 703 saved per additional patient who had treatment success with PCS compared with FLACS. We observed no severe adverse events during the femtosecond laser procedure, and most of the complications in the FLACS group related to the primary outcome measures occurred during the phacoemulsification phase or postoperatively. Interpretation Despite its advanced technology, femtosecond laser was not superior to phacoemulsification in cataract surgery and, with higher costs, did not provide an additional benefit over phacoemulsification for patients or health-care systems. Funding French Ministry of Social Affairs and Health.

To assess the effect of pelvic drainage after rectal surgery for cancer.Pelvic sepsis is one of the major complications after rectal excision for rectal cancer. Although many studies have confirmed infectiveness of drainage after colectomy, there is still a controversy after rectal surgery.This multicenter randomized trial with 2 parallel arms (drain vs no drain) was performed between 2011 and 2014. Primary endpoint was postoperative pelvic sepsis within 30 postoperative days, including anastomotic leakage, pelvic abscess, and peritonitis. Secondary endpoints were overall morbidity and mortality, rate of reoperation, length of hospital stay, and rate of stoma closure at 6 months.A total of 494 patients were randomized, 25 did not meet the criteria and 469 were analyzed: 236 with drain and 233 without. The anastomotic height was 3.5 ± 1.9 cm from the anal verge. The rate of pelvic sepsis was 17.1% (80/469) and was similar between drain and no drain: 16.1% versus 18.0% (P = 0.58). There was no difference of surgical morbidity (18.7% vs 25.3%; P = 0.83), rate of reoperation (16.6% vs 21.0%; P = 0.22), length of hospital stay (12.2 vs 12.2; P = 0.99) and rate of stoma closure (80.1% vs 77.3%; P = 0.53) between groups. Absence of colonic pouch was the only independent factor of pelvic sepsis (odds ratio = 1.757; 95% confidence interval 1.078-2.864; P = 0.024).This randomized trial suggests that the use of a pelvic drain after rectal excision for rectal cancer did not confer any benefit to the patient.

International audience; Recent data suggest that the nutritional status of patients who are on the waiting list for kidney transplantation, influence outcomes after renal transplantation. Body composition (BC) analysis is rarely included in pretransplant evaluation. The aim of this study was to determine how alteration of the BC of these patients could influence pretransplant and post-transplant care. We compared the BC of French patients on a waiting list for kidney transplantation to a sex- and age-matched healthy, European control population. Patients were included when listed for kidney grafting in a prospective longitudinal study (CORPOS). Biological nutritional parameters, fat free mass (FFM) and fat mass (FM) estimated by dual-energy x-ray absorptiometry (DXA) were assessed on the day of wait-list registration. FFM and FM index (FFMi - FMi) are the ratio of FFM and FM to height squared. Results are expressed as median (range). These indexes were compared with previous study values used as a normal range in nutritional assessment and clinical practice. The study included 28 women and 70 men aged 25.3 to 65.9 y. Body mass index ranged from 16.8 kg/m² to 39.4 kg/m². Compared with controls, FMi was higher in women (10.6 kg/m² [3.7-18.6 kg/m²]) than in men (8.1 kg/m² [3.5-13.3 kg/m²] in M) and FFMi was lower in women (14.3 kg/m² [11.8-21.4 kg/m²]) than in men (17.9 kg/m² [13.9-24.2 kg/m²]) (P < 0.01), reflecting an abnormal distribution of body compartments. All biological parameters were within the normal range. BC abnormalities, which can only be detected with the use of DXA, are present in patients on a kidney transplantation waiting list. Detection of these abnormalities could influence the post-transplantation survey in order to prevent the frequent risk for developing metabolic complications after the procedure.

Background During on-pump cardiac surgery, hemorrhagic complications occur frequently. Fresh-frozen plasma (FFP) is widely transfused to provide coagulation factors. Yet, no randomized clinical trial has demonstrated its benefits on mortality. We assessed the relationship between therapeutic transfusion of FFP and 30-day mortality in cardiac surgery patients suffering from excessive bleeding in a prospective cohort study. Study Design and Methods Adult patients who underwent on-pump cardiac surgery and experienced excessive bleeding during the 48-hour perioperative period were recruited from 15 French centers between February 2004 and January 2006. Patients who received a preventive FFP transfusion were excluded. The association between FFP transfusion and all cause 30-day mortality was estimated using a Cox proportional hazards model, adjusted for confounding. A propensity score (PS) sensitivity analysis was also performed. Results Among 967 patients included in this study, 58.1% received FFP. The median dose was 11.3 mL/kg (interquartile range, 7.6-19.5). The cumulative 30-day mortality rate was 11.3% (95% confidence interval [CI], 9.5-13.5). FFP transfusion was associated with a higher 30-day mortality (hazard ratio [HR], 3.2; 95% CI, 1.7-6.1) in univariate analysis; however, after adjusting for prognostic factors, there was no longer any association (HR, 1.5; 95% CI, 0.8-3.0, p = 0.20). The results of the PS analysis were consistent with the adjusted analysis. Conclusion Among on-pump cardiac surgery patients experiencing excessive perioperative bleeding, there is no evidence of a beneficial impact of FFP transfusion on mortality.

Background It is no longer safe to use large tidal volumes ( V T ) (>8 ml kg −1 ) for one-lung ventilation (OLV), and limiting plateau pressure should be a major objective. Due to the specificity of OLV, the use of positive end-expiratory pressure (PEEP) remains controversial. This study determined whether at the same low plateau pressure, reducing V T and increasing PEEP were not inferior to larger V T and lower PEEP ventilation in terms of oxygenation. Methods This prospective, randomized, non-inferiority, cross-over trial included 88 patients undergoing open thoracotomy who received two successive ventilatory strategies in random order: V T (8 ml kg −1 of ideal body weight) with low PEEP (5 cm H 2 O), or low V T (5 ml kg −1 ) with a high PEEP. Respiratory rate and PEEP were, respectively, adjusted to maintain constant ventilation and plateau pressure. The primary endpoint was the P a O 2 / F I O 2 ratio under each ventilatory strategy. Results The non-inferiority of low- V T ventilation could not be established. The mean adjusted P a O 2 / F I O 2 ratio was lower overall during low- V T ventilation, and differences between the two ventilatory modes varied significantly according to baseline (T0) P a O 2 / F I O 2 . Decreased oxygenation during low V T was smaller when baseline values were low. Systolic arterial pressure was not lower during low- V T ventilation. Conclusion During OLV, lowering V T and increasing PEEP, with the same low plateau pressure, reduced oxygenation compared with larger V T and lower PEEP. This strategy may reduce the risk of lung injury, but needs to be investigated further.

Introduction L’insuffisance renale chronique est associee a des alterations de la reponse immunitaire humorale et une reponse vaccinale diminuee. Une etude preliminaire chez 15 patients non immunises apres au moins une vaccination anterieure et dialyses pendant trois mois sur polymethylmetacrylate (PMMA) a montre une reponse vaccinale chez 60 % d’entre eux nettement superieure a ce qui est rapporte dans la litterature. Cette reponse etait associee a une baisse du CD40 soluble, inhibiteur naturel de la reponse humorale. Nous avons voulu confirmer ces resultats par une etude randomisee multicentrique. Patients et methodes Vingt-cinq patients ont ete inclus (14 sur PMMA [BKF2.1], 11 sur polysulfone haute permeabilite). Selon le protocole, les patients devaient etre dialyses pendant 40 semaines et ont recu deux doses d’Engerix B20 a Semaine 12, S16, S20 et S36. Le critere de jugement principal est la reponse vaccinale a S40 definie par un taux d’Ac anti-HbS > 10 UI/L. La cinetique de la reponse vaccinale a ete evaluee. Le taux de CD40s a ete evalue a S0 et S12. Resultats A l’issue de l’etude, 58,3 % des patients sous PMMA vs 75 % des patients sous Polysulfone ont repondu a la vaccination (p = 0,64). Le taux median d’AC anti-HbS a S40 chez les repondeurs est de 496 (min–max : 81;750) vs 395 (26;750) UI/mL pour la PMMA et la polysulfone respectivement (p = 0,46). Le taux median de CD40s a S12 est de 306 (93;814) vs 491 (142;726) pg/mL (p = 0,21). La variation mediane du CD40s entre S0 et S12 est de 5 (−425;255) vs 64 (−189;357) pg/mL (p = 0,55). Il y a une tendance a un taux plus bas de CD40s a S12 chez les patients non repondeurs a la vaccination : mediane = 193 (142;470) vs 413 (93;814) pg/mL ; p = 0,08. Pour l’ensemble de la cohorte, les patients repondeurs a la vaccination ont tendance a etre plus jeunes (âge median 64 ans vs 76 ans ; p = 0,16). Discussion L’hypothese d’une epuration du CD40s par adsorption sur PMMA qui permettrait une meilleure reponse vaccinale n’est pas confirmee dans notre etude. Il est possible que la bonne reponse vaccinale observee dans les deux groupes et particulierement sous Polysulfone, soit liee a l’epuration d’autres substances par les membranes haute permeabilite ou a un meilleur suivi de la vaccination dans le cadre d’un protocole. Conclusion Nous n’avons pas observe de superiorite de la membrane en PMMA sur la reponse vaccinale contre le virus de l’hepatite B comparee a la polysulfone haute permeabilite.

Des etudes preliminaires laissent penser que le thermalisme a orientation psychosomatique pourrait etre efficace pour traiter le trouble d’anxiete generalisee. Nous avons compare le thermalisme a orientation psychosomatique a la Paroxetine dans un essai randomise muticentrique pendant 8 semaines. Deux cent trente-sept patients presentant un trouble d’anxiete generalisee (DSM-IV) ont ete inclus dans l’essai, 117 ont ete randomises dans le groupe thermalisme et 120 dans le groupe Paroxetine. L’efficacite a ete evaluee a partir des scores obtenus a l’echelle d’appreciation de l’anxiete d’Hamilton (HAMA). Deux cent sept patients ont ete suivis jusqu’a la fin de l’etude. Les scores obtenus a l’HAMA montrent une amelioration dans les deux groupes avec une superiorite en faveur du traitement par thermalisme par rapport a la Paroxetine (p < 0,0001). La mise en place de cette etude s’est heurtee a differents problemes methodologiques (notamment parce que l’utilisation d’un placebo n’etait pas possible) qui sont discutes par les auteurs.

Background: There is insufficient data to reliably assess the benefit of bronchodilators in ventilated premature neonates. Objectives: To compare the efficacy/tolerance of inhaled ipratropium bromide (IB) vs. terbutaline (T) and to describe factors associated with their efficacy. Methods: A cross-over randomized controlled double-blind trial including intubated neonates with respiratory distress syndrome. Two puffs of IB or T were administered at 0, 20, 40 min. Passive respiratory system resistance (Rrs) and compliance (Crs) were measured at 0, 20, 40, 60 min. A positive response was defined as a >2 individual coefficients of variation decrease in Rrs or increase in Crs. Results: Twenty-one infants (gestational age (mean ± SD): 27.3 ± 1.6 weeks; birth weight: 947 ± 250 g; postnatal age: 20 ± 9 days) were included. At 60 min, no treatment effect for Rrs and Crs could be identified (cross-over analysis). Overall data (irrespective of order of administration) showed that after 6 puffs, the decrease in Rrs was greater in the IB vs. T group (–17.0 ± 22.2% vs. –11.3 ± 26.7%, respectively (NS)). Thirty-eight percent of infants responded to IB vs. 43% to T. However, in 19% of patients, decreased Crs was observed after 6 puffs of T. No marker of a positive or paradoxical response could be identified. Treatment was well-tolerated. Conclusion: High doses of bronchodilators are required in ventilated neonates, but the positive response rate was

Objectives The objectives were to estimate the prevalence of Chlamydia trachomatis infection in subfertile couples and to study the relationship between markers of C. trachomatis infection and male infertility as well as pregnancy rates after in vitro fertilization (IVF). Study design All consecutive couples consulting for infertility and IVF in Pellegrin Hospital were screened for C. trachomatis by direct (PCR test) and serological methods. Results Two hundred and seventy-seven couples were included in the study (mean age in years: 35 for men, 32 for women; mean duration of infertility: 4 years). The most frequent indication for IVF was tubal factor in 33%, endometriosis in 6%, dysovarian function in 12%, male infertility in 36% and others in 13%. C. trachomatis PCR was positive in 1.2% of men, 95% confidence interval (CI 95% ): (0.2%; 3.3%) and in 2.7% of women, CI 95% : (1.1%; 5.5%). When combining all chlamydial markers, 17.3% of men, CI 95% : (12.7%; 22.8%) and 20.4% of women, CI 95% : (15.6%; 25.9%) had at least one positive marker. The presence of positive markers was not associated with altered semen characteristics. Couples with positive markers had a pregnancy rate of 23.1% (12 out of 52) compared with 20.2% (24 out of 119) among those with negative markers. Conclusion In this population, the presence of past or current C. trachomatis infection was associated with neither semen characteristics nor outcome of IVF in subfertile couples.

Introduction et but de l’etude La transplantation renale (TR) est le traitement de choix de l’insuffisance renale chronique terminale. Elle s’accompagne de modifications de la composition corporelle, en particulier d’une augmentation de la masse grasse. Le devenir de la masse cellulaire active (MCA) dans cette population ainsi que ses determinants sont moins bien connus. Nous presentons ici les resultats de l’etude prospective CORPOS decrivant l’evolution de la MCA avant et apres greffe renale. Les parametres cliniques et biologiques l’influencant sont analyses. Materiel et methodes La masse maigre (MM) et la masse grasse (MG) ont ete mesurees par absorptiometrie bi photonique (DEXA). L’eau corporelle totale et l’eau extra cellulaire (EEC) ont ete evaluees par bioimpedancemetrie multifrequence (Imp SFB7 − Impedimed Pty Ltd. Queensland, Australia). La masse cellulaire active (MCA) a ete calculee selon MCA = MM – EEC. Les apports alimentaires, le score global d’activite physique (auto questionnaire de Baecke), les parametres nutritionnels ont ete recueillis simultanement aux mesures anthropometriques, au moment de l’inscription sur liste d’attente de greffe, M12 apres l’inscription, a M1, M6, M12, M. 24 post greffe. Les resultats sont exprimes en moyenne +/ – ecart-type. Un modele mixte avec changements de pente est utilise pour l’analyse des variables explicatives. Resultats et Analyse statistique 80 patients (25 femmes et 55 hommes) âges de 51,9 +/−11 ans ont ete inclus. La duree moyenne d’attente avant greffe est de 17 +/−11 mois. La MCA diminue pendant la periode pre greffe (33,4 +/−7,1 kg a 32,9 +/−8,1 kg), avec un nadir a M1 post greffe (30,2 +/−6,5 kg). Elle remonte ensuite avec un maximum a M. 12 post greffe (31,7 +/−7,1kg). L’evolution des autres parametres est decrite dans le tableau ci-dessous : Inclusion M12 pre TR M1 post TR M6 post TR M12 post TR M24 post TR IMC (kg/m2) 25,7+/− 4,0 26,2 +/−4,7 24,8 +/−3,8 25,1 +/−3,8 25,5 +/−3,9 25,9 +/−4,4 CRP (mg/l) 6,2 +/− 9,1 4,1 +/−5,3 9,9 +/−12,4 6,2 +/−6,8 8,0 +/−13,4 4,2 +/−4,1 Apports proteiques (g/kg/j) 1,1+/−0,3 1,0+/−0,3 1,1+/−0,3 1,1 +/−0,2 1,1 +/−0,3 1,1 +/−0,3 Activite physique (UA) 6,4 +/− 2,1 5,8 +/−1,8 4,9 +/−1,8 5,8 +/−1,84,9 5,8 +/−1,8 5,8 +/−1,8 Dose corticoides (mg/j) 0,9 +/− 3,6 1,0 +/−3,8 36,2 +/−20,3 9,7 +/−7,6 6,3 +/−5,4 4,3 +/−4,5 L’utilisation d’un modele mixte avec changements de pente (M1 et M12 post greffe) prenant en compte l’âge, le sexe, l’albuminemie, la CRP, les apports proteiques et energetiques, le score d’activite physique et la dose de corticoides permet de conclure que l’evolution avant et apres TR de la MCA est significativement influencee par le sexe (p Conclusion La MCA diminue avant la TR, pour re augmenter ensuite la premiere annee post greffe. Cette evolution est plus marquee chez les hommes, positivement correlee a l’activite physique et negativement influencee par la corticotherapie. L’activite physique, faible dans la population des insuffisants renaux, doit etre encouragee.

To correlate the short-term neurological outcome of early cerebral abnormalities using cranial ultrasonography (US) in premature newborns at their hospital discharge.Each newborn born33 weeks of gestational age (GA) included in a prospective cohort benefited of 3 US: two early in the first week of life (D3 and D8) and one later (Months 1-2) standardized US pulsed Doppler. A US abnormality was ≥one morphologic abnormality (moderate: intra-ventricular hemorrhage (IVH) grades 1-2; severe: IVH 3-4, periventricular leukomalacia, persistent flares). Correlates of having a severe adverse neurological outcome were analyzed using a stepwise backward logistic regression adjusted model with gestational age, early cerebral abnormality at Days 3-8, velocity and with variables with correlation probabilities with p0.25 in the univariate analysis among occurring co-morbidity events previously defined. Two adjusted logistic regression analyses were conducted including or not velocity data because of missing information.Among 452 premature included, 11.3% did not have an early US, 74.8% had a normal early US, 13.9% ≥one early morphological US abnormality (10.0% moderate, 3.9% severe). At hospital discharge, 40% were still alive with a normal late US, 33% alive with ≥one late morphological US abnormality (10% moderate, 23% severe), and 10% died. Adjusted correlates of a late US severe abnormality or a neurological related death at hospital discharge were: early US abnormality (aOR: 8.7, 95% CI: 2.3-33.6), GA29 weeks (aOR: 2.8 95% CI: 1.4-5.4).This study shows that early US morphological abnormalities increase significantly when the GA decreases and is highly predictive of the occurrence of a further late US severe abnormality or neurological related death at hospital discharge.

Objective The ERAMS study addressed the value of arterial stiffness in predicting the severity of systemic sclerosis. Methods ERAMS was a prospective multicentre cohort study including patients with definite systemic sclerosis. Arterial stiffness was measured by the standardized non-invasive QKd 100-60 method. Clinical evaluation, biological measurements, functional respiratory tests and cardiac Doppler echography were performed at inclusion then each year until 3 years' follow-up was completed. Progression was defined as mild (articulations, muscle, oesophagus or skin involvement) or severe (lung, heart or kidney involvement) by a critical event committee. The prediction of severe progression was studied for QKd 100-60 as well as clinical and biological data at baseline by univariate and multivariate analysis. Results Ninety-nine patients were included (81 women, 18 men, mean age 57 years, standard deviation 12.5). Although their blood pressure profile was normal, half the patients had increased arterial stiffness (QKd 100-60 < 200ms). There was a significant relationship between age-adjusted arterial stiffness and decrease in carbon dioxide diffusion (P

Objective To assess the effects of delirium on the institutionalization rate, taking into account geriatric syndromes and nutritional status. Methods This population-based study took place in an acute care unit and included participants older than 75 years, arriving from home and later discharged. Confusion Assessment Method (CAM) symptoms were recorded by the nurses within 24 hours after admission and every 3 days. Delirium was defined using the CAM algorithm, and subsyndromal delirium responded to symptoms not fulfilling the CAM algorithm. These delirium categories were either present at admission (prevalent) or occurred during the hospital stay (incident). Participants were classified as having a low dietary intake when energy intake was at any time lower than 600 kcal/d. Age, sex, known cognitive impairment, weight, functional dependency, and laboratory testing as well as diagnoses were also recorded. Step-by-step backward logistic regression was used to identify predictors of institutionalization. Results Among 427 patients, 310 (72.6%) were discharged and were compared with 117 (27.4%) participants admitted to an institution. Female sex (odds ratio [OR]: OR 2.15, 95% confidence interval [CI]: CI 1.22-3.78), prevalent delirium (OR 3.19, 95% CI 1.33-7.64), subsyndromal delirium (OR 2.72, 95% CI 1.48-5.01), incident subsyndromal delirium (OR 4.27, 95% CI 2.17-8.39), low dietary intake (OR 2.50, 95% CI 1.35-4.63), and a fall (OR 2.16, 95% CI 1.22-3.84) or a diagnosis of stroke (OR 2.03, 95% CI 1.04-3.94) were independent predictors of institutionalization. Conclusions Symptoms of delirium and severe nutritional impairment led patients to geriatric institutions. Therefore, these institutions need to implement policies that address both of these issues.