BACKGROUND: Laminar airflow filters have been suggested as a potential preventive factor for surgical site infections, given their ability to reduce the airborne microbiological load. However, their role is still unclear, and evidence regarding vascular surgery patients is scarce. Our aim was to assess the impact of laminar-airflow filters on surgical site infections. METHODS: This single-centre retrospective cohort study was conducted with vascular surgery patients who underwent arterial vascular intervention through a groin incision between July 2018 and July 2019 (turbulent airflow cohort) and July 2020 and July 2021 (laminar airflow cohort). Data were prospectively collected from electronic medical files. We estimated the cumulative incidence of surgical site infections and its 95% confident interval (95%CI). A propensity score matching analysis was performed. RESULTS: We included 200 patients, 78 in the turbulent airflow cohort and 122 in the laminar airflow cohort. The cumulative incidence was 15.4% (12/78; 95%CI: 9.0-25.0%) in the turbulent-airflow cohort and 14.8% (18/122; 95%CI: 9.5 -22.1%) in the laminar-airflow cohort (p-value: 1.00). The propensity score matching yielded a cumulative incidence of surgical site infection of 13.9% (10/72) with turbulent airflow and 12.5% (9/72) with laminar airflow (p-value: 1.00). Risk factors associated with infection were chronic kidney disease (OR 2.70; 95%CI: 1.14-6.21) and a greater body mass index (OR 1.47; 95%CI: 1.01-2.14). CONCLUSION: Laminar airflow filters were associated with a non-significant reduction of surgical site infections. Further research is needed to determine its usefulness and cost-effectiveness. Surgical site infection incidence was associated with chronic kidney disease and a greater body mass index. Hence, efforts should be made to optimize the body mass index before surgery and prevent chronic kidney disease in patients with known arterial disease.
BACKGROUND: Glenoid reconstruction with a bone block for anterior glenoid bone loss (GBL) has shown excellent outcomes. However, fixation techniques that require metal implants are associated with metal-related complications and bone graft resorption. HYPOTHESIS: Arthroscopic glenoid reconstruction using a tricortical iliac crest bone graft (ICBG) and metal-free suture tape cerclage fixation can safely and effectively restore the glenoid surface area in patients with recurrent anterior shoulder instability and anterior GBL. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Adult patients (≥18 years) of both sexes with recurrent anterior shoulder instability and anterior GBL ≥15% were enrolled. These patients underwent arthroscopic glenoid reconstruction with ICBGs and metal-free suture tape cerclage fixation. The effectiveness and clinical outcomes with this technique were evaluated at 24 months using functional scores. Resorption of the graft articular surface was assessed by computed tomography, with the graft surface divided into 6 square areas aligned in 2 columns. Descriptive analysis was conducted. RESULTS: A total of 23 consecutive patients met inclusion criteria (22 male, 1 female; mean age, 30.5 ± 7.9 years). The mean preoperative GBL was 19.7% ± 3.4%, and there were 15 allograft and 8 autograft ICBGs. All patients exhibited graft union at 3 months. The median follow-up was 38.5 months (interquartile range, 24-45 months). The Western Ontario Shoulder Instability Index, Rowe, Constant-Murley, and Subjective Shoulder Value scores improved from preoperatively (35.1%, 24.8, 83.1, and 30.9, respectively) to postoperatively (84.7%, 91.1, 96.0, and 90.9, respectively) (P < .001). No differences in clinical scores were observed between the graft types. One surgical wound infection was reported, and 2 patients (8.7% [95% CI, 2.4%-26.8%]) required a reoperation. The mean overall glenoid surface area increased from 80.3% ± 3.5% to 117.0% ± 8.3% immediately after surgery before subsequently reducing to 98.7% ± 6.2% and 95.0% ± 5.7% at 12 and 24 months, respectively (P < .001). The mean graft resorption rate was 18.1% ± 7.9% in the inner column and 80.3% ± 22.4% in the outer column. Additionally, 3 patients treated with an allograft (20.0% [95% CI, 7.1%-45.2%]), including the 2 with clinical failures, exhibited complete graft resorption at the last follow-up. CONCLUSION: Arthroscopic glenoid reconstruction using an ICBG and metal-free suture tape cerclage fixation was safe and effective, yielding excellent clinical outcomes. Resorption of the graft articular surface predominantly affected the nonloaded areas beyond the best-fit circle perimeter.
Arthroscopy , Bone Transplantation , Joint Instability , Shoulder Joint , Tomography, X-Ray Computed , Humans , Male , Female , Adult , Joint Instability/surgery , Bone Transplantation/methods , Shoulder Joint/surgery , Shoulder Joint/diagnostic imaging , Arthroscopy/methods , Young Adult , Recurrence , Bone Resorption/surgery , Bone Resorption/diagnostic imaging , Ilium/transplantation , Ilium/surgery , Treatment Outcome
INTRODUCTION: Ceramic-on-ceramic bearings have been widely used since their introduction in the 1970s. First-generation ceramics have very high fracture (breakage) rates. To overcome this, in the 1990s, modular cotyloid insert designs were developed, consisting of a ceramic and polyethylene composite (sandwich-type) liner; however, high implant fracture rates were observed in the medium term. We aimed to estimate the cumulative incidences of revision surgery (implant failure) and implant failure due to fractures, survival rates (time-to-revision surgery and time-to-fracture), and the long-term clinical and radiological outcomes in our series. METHODS: This was an observational, longitudinal, ambispective, single-centre study based on patients who underwent primary total hip arthroplasty (THA) using a sandwich-type liner (Cerasul), only available in our tertiary hospital between January 1999 and December 2002. Cumulative incidences were estimated and the 95% confidence interval (95% CI) was calculated. The Kaplan-Meier method was used to assess the time-to-revision surgery and time-to-fracture. RESULTS: 54 patients (49 men) were included, accounting for 59 sandwich-type linear implants. The mean (range) age was 47.4 (22-57) years. The primary THA indications were osteoarthritis (28 patients), osteonecrosis (14), childhood pathology sequelae (11), and inflammatory arthritis (6). The cumulative incidence of revision surgery by implants was 8.5% (5/59, 95% CI, 3.5-19.2%), 9.3% by patients (5/54, 95% CI, 4.0-19.9%), and 5.1% by implant fractures (3/59, 95%CI, 1.7-13.9%). The median (Interquartile Range, IQR) time-to-revision surgery was 158 (72.5-161) months, and the time to fracture was 182 (138-215) months. All primary THAs had good clinical and long-term survival outcomes. All implants had signs of solid fixation. CONCLUSIONS: After a 20-year follow-up period, the polyethylene-ceramic sandwich-type liner showed a long survival rate and low cumulative incidence of implant fracture; however, implant fractures remain the main complication. Orthopaedic surgeons should be aware that some patients still have this type of prosthesis and must be capable of responding quickly if a fracture occurs.
PURPOSE: The optimal management of patients with compressive radiculopathy with motor deficit (CRMD) is controversial. Our goal was to provide evidence on the impact of the spine surgeons' experience on surgical planning and timing. METHODS: Spine surgeons were invited to participate in a 5-item online survey. A literature review was carried out. RESULTS: Of the 94 spine surgeons who responded to the survey, 70% would operate early on a patient with acute CRMD, but only 48% would do so if the radicular pain had resolved. Surgeons with more than 15 years of experience chose more conservative options. Twenty published studies were selected in the literature review. CONCLUSION: The optimal management of patients with compressive radiculopathy associated with a non-progressive motor loss remains unknown. The results of our survey show that surgeons with extensive surgical experience take a more conservative and cautious approach.
Radiculopathy , Surgeons , Humans , Cross-Sectional Studies , Radiculopathy/complications , Radiculopathy/surgery , Spine , Surveys and Questionnaires
Introducción: La fibra es el tratamiento inicial en el estreñimiento crónico funcional. Sin embargo, su papel en el grupo de pacientes con disinergia defecatoria no está bien establecido. El objetivo del estudio es evaluar la eficacia y la seguridad de la dieta alta en fibra en pacientes con disinergia defecatoria en el tratamiento con biofeedback anorrectal. Pacientes y métodos: Se realizó un ensayo clínico exploratorio, aleatorizado (1:1), doble ciego, controlado add-on, en un centro de referencia en España en pacientes con estreñimiento funcional y disinergia defecatoria de acuerdo con criterios de ROMAIV. Grupo control: tratamiento con biofeedback y dieta baja en fibra (15-20g/día). Grupo experimental: tratamiento con biofeedback y dieta alta en fibra (25-30g/día). Se analizó: respondedor (variable principal), paciente en quien la disinergia defecatoria se había corregido (>20% de reducción de la presión anal durante la maniobra defecatoria y prueba de expulsión del balón normal); parámetros anorrectales (relajación anal, reducción del esfuerzo); seguridad (síntomas abdominales: flatulencia, dolor, borborigmo, distensión). Resultados: Un total de 44 pacientes fueron aleatorizados: 22 por grupo. El porcentaje de respondedores fue del 75% (15/20; IC95%: 53-89%) grupo control y 70% (14/20; IC95%: 48-85%) grupo experimental, p=0,225. Solo se observaron diferencias a favor del grupo control en síntomas abdominales: flatulencias (p=0,028), distensión abdominal (p=0,041) y bienestar digestivo (p=0,043). Conclusión: En pacientes con disinergia defecatoria la dieta alta en fibra no solo no mejora la eficacia del biofeedback anorrectal, sino que se asocia a una pérdida de la mejoría de los síntomas abdominales. (AU)
Introduction: Fiber is the initial treatment in chronic functional constipation. However, its role in the group of patients with defecatory dyssynergy is not well established. The objective of the study is to evaluate the efficacy and safety of a high fiber diet in patients with defecatory dyssynergy in the treatment with anorectal biofeedback. Patients and methods: An exploratory, randomized (1:1), double-blind, controlled «add-on» clinical trial was carried out in a reference center in Spain in patients with functional constipation and defecatory dyssynergy according to the ROMEIV criteria. Control group: treatment with biofeedback and low-fiber diet (15-20g/day). Experimental group: treatment with biofeedback and high fiber diet (25-30g/day). Analyzed: responder (primary endpoint), patient whose defecatory dyssynergy had been corrected (>20% reduction in anal pressure during the defecation maneuver and normal balloon expulsion test); anorectal parameters (anal relaxation, reduced straining); safety (abdominal symptoms: flatulence, pain, borborygmus, bloating). Results: A total of 44 patients were randomized: 22 per group. The percentage of responders was 75% (15/20; 95%CI: 53 89%) control group and 70% (14/20; 95%CI: 48-85%) experimental group, P=.225. Differences in favor of the control group were only observed in abdominal symptoms: flatulence (P=.028), abdominal distension (P=.041) and digestive comfort (P=.043). Conclusions: In patients with defecatory dyssynergy, a high-fiber diet not only does not improve the efficacy of anorectal biofeedback but is associated with a loss of improvement in abdominal symptoms. (AU)
Humans , Male , Female , Adult , Middle Aged , Aged , Defecation , Flatulence , Biofeedback, Psychology , Constipation/diagnosis , Constipation/etiology , Constipation/therapy , Manometry
BACKGROUND: Humeral shaft fractures with extension to the proximal third are increasingly frequent and technically more demanding. Surgical management of proximal metaphyseal junction humeral fractures is challenging. The aim of this study was to assess the safety, reproducibility, and possibility of early and completed rehabilitation in the percutaneous treatment with helical plates in humeral shaft fractures with proximal extension. PATIENTS AND METHODS: This was a descriptive, retrospective, single-centre cohort study based on consecutive patients with proximal metaphyseal junction humeral fractures (MIPO-helical-plate-Broggi's cohort). Surgical technique (minimally invasive approach and osteosynthesis): percutaneous treatment with a twisted plate (helical plates). STUDY VARIABLES: i): Intraoperative and postoperative (up to 1 year after surgery) safety; ii) Reproducibility of the surgical technique [number (percentage) of patients with surgical technique success]. The surgical technique success was defined as the recovering without neurovascular, implant failures and infection issues after one year follow up; and iii) Early and completed (3 months) rehabilitation [number (percentage) of patients]. A descriptive analysis was performed. RESULTS: Between April 2010 to January 2022, we received 443 humeral shaft fractures at our unit. Of these, 350 fractures were treated surgically. 157 (44.9%) were treated using the minimally invasive approach and osteosynthesis technique with extramedullary implants, of which 46 (46/157, 29.3%, 9 men and 37 women) were performed with almost orthogonally twisted Philos® helical plates. The median (range) age was 67 (51-94) years. STUDY OUTCOMES: i) Safety: None intraoperative events were gathered. No neurovascular, implant failure and infection issues were reported one year after surgery.; ii) Reproducibility of the surgical technique: only 1 failure (2%, 95%CI:0-11%), who was reoperated; and iii) Early and 3 month of rehabilitation was completed in 45 (98%, 95%CI:89-100%) patients. Forty-five (98%, 95%CI:89-100%) patients recovered their previous function the year after surgery. CONCLUSIONS: The treatment of humeral shaft fractures with proximal extension based on a minimally invasive approach and osteosynthesis: percutaneous treatment with a twisted plate (helical plates), as this is a submuscular and extraperiosteal technique, is a safe and reproducible technique, and promotes early rehabilitation. In our opinion, it is surgical technique whose main requirement is a good knowledge of topographic anatomy.
Humeral Fractures , Shoulder Fractures , Male , Humans , Female , Aged , Aged, 80 and over , Humeral Fractures/diagnostic imaging , Humeral Fractures/surgery , Retrospective Studies , Cohort Studies , Reproducibility of Results , Fracture Healing , Treatment Outcome , Humerus , Fracture Fixation, Internal/methods , Bone Plates , Shoulder Fractures/surgery , Minimally Invasive Surgical Procedures/methods
Treatment failure occurs in about 25% of patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. We assessed whether cloxacillin plus fosfomycin achieves better treatment success than cloxacillin alone in hospitalized adults with MSSA bacteremia. We conducted a multicenter, open-label, phase III-IV superiority randomized clinical trial. We randomly assigned patients (1:1) to receive 2 g of intravenous cloxacillin alone every 4 h or with 3 g of intravenous fosfomycin every 6 h for the initial 7 days. The primary endpoint was treatment success at day 7, a composite endpoint with the following criteria: patient alive, stable or with improved quick Sequential Organ Failure Assessment score, afebrile and with negative blood cultures for MSSA, adjudicated by an independent committee blinded to treatment allocation. We randomized 215 patients, of whom 105 received cloxacillin plus fosfomycin and 110 received cloxacillin alone. We analyzed the primary endpoint with the intention-to-treat approach in 214 patients who received at least 1 day of treatment. Treatment success at day 7 after randomization was achieved in 83 (79.8%) of 104 patients receiving combination treatment versus 82 (74.5%) of 110 patients receiving monotherapy (risk difference 5.3%; 95% confidence interval (CI), -5.95-16.48). Secondary endpoints, including mortality and adverse events, were similar in the two groups except for persistent bacteremia at day 3, which was less common in the combination arm. In a prespecified interim analysis, the independent committee recommended stopping recruitment for futility prior to meeting the planned randomization of 366 patients. Cloxacillin plus fosfomycin did not achieve better treatment success at day 7 of therapy than cloxacillin alone in MSSA bacteremia. Further trials should consider the intrinsic heterogeneity of the infection by using a more personalized approach. ClinicalTrials.gov registration: NCT03959345 .
Bacteremia , Fosfomycin , Staphylococcal Infections , Adult , Humans , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/therapeutic use , Bacteremia/drug therapy , Cloxacillin/adverse effects , Fosfomycin/therapeutic use , Methicillin/therapeutic use , Staphylococcal Infections/drug therapy , Staphylococcus aureus , Treatment Outcome , Drug Therapy, Combination/adverse effects
BACKGROUND: Apixaban's technical sheet does not recommend its use in clinical practice for patients with chronic kidney disease undergoing haemodialysis. However, recent studies indicate that apixaban could be a safe oral anticoagulant in these kinds of patients who do not present valvular atrial fibrillation. We developed and validated ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) procedures for measuring apixaban concentrations in plasma, dialysate liquid, and urine. MATERIAL AND METHODS: Simple protein precipitation was implemented to prepare samples. Chromatographic separations were achieved on an Acquity®-UPLC®-BEHTM (2.1x100 mm id, 1.7 µm) reverse-phase C18 column using a water/acetonitrile non-linear gradient containing 0.1 % formic acid at a 0.4 mL/min flow rate. Apixaban and its internal standard (apixaban-d3) were detected by electrospray ionisation mass spectrometry in positive and multiple reaction monitoring modes, using transitions of 460.3 â 199.0/443.2 and 463.3 â 202.0, respectively. RESULTS: No significant interferences and carry-overs were observed. Precisions, absolute relative biases, normalised-matrix factors, and normalised recoveries were ≤ 12.2%, ≤8.0%, 94.3-105.1%, and 93.9-105.4%, respectively. Linearity was observed between 5 and 500 µg/L for plasma/dialysate liquid and 5-1000 µg/L for urine. CONCLUSIONS: The validated UHPLC-MS/MS procedures could help support a pharmacokinetic study in non-valvular atrial fibrillation subjects with chronic kidney disease undergoing haemodialysis and apixaban-based anticoagulant therapy.
Atrial Fibrillation , Renal Insufficiency, Chronic , Humans , Chromatography, High Pressure Liquid/methods , Tandem Mass Spectrometry/methods , Atrial Fibrillation/drug therapy , Renal Dialysis , Anticoagulants , Renal Insufficiency, Chronic/therapy , Dialysis Solutions
BACKGROUND: Chronic non-cancer pain (CNCP) treatment's primary goal is to maintain physical and mental functioning while improving quality of life. Opioid use in CNCP patients has increased in recent years, and non-pharmacological interventions such as music listening have been proposed to counter it. Unlike other auditive stimuli, music can activate emotional-regulating and reward-regulating circuits, making it a potential tool to modulate attentional processes and regulate mood. This study's primary objective is to provide the first evidence on the distinct (separate) effects of music listening as a coadjuvant maintenance analgesic treatment in CNCP patients undergoing opioid analgesia. METHODS AND ANALYSIS: This will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences.Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints' evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation. ETHICS AND DISSEMINATION: The study protocol has been reviewed, and ethics approval has been obtained from the Bellvitge University Hospital Institutional Review Board, L'Hospitalet de Llobregat, Barcelona, Spain. The results from this study will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05726266.
Cancer Pain , Chronic Pain , Music , Humans , Chronic Pain/drug therapy , Analgesics, Opioid/therapeutic use , Tertiary Care Centers , Quality of Life , Sound Recordings , Randomized Controlled Trials as Topic , Clinical Trials, Phase II as Topic
BACKGROUND: Low back pain is a common condition that becomes even more prevalent with aging. A non-pharmacological multidisciplinary approach for chronic non-specific low back pain (CNSLBP) has been recommended, but integrating different healthcare professionals is challenging. A multidisciplinary group videoconferencing approach (MGVA) can be helpful. Our aim was to provide evidence on MGVA's feasibility in managing CNSLBP and its impact on clinical practice. METHODS: We conducted an open-label, randomized, controlled, parallel-group pilot clinical trial with CNSLBP patients irresponsive to conservative treatment. Patients between 18 and 67 years of age were randomly assigned (1:1) to either Standard-of-Care + MGVA (experimental group) or Standard-of-Care alone (control group). MGVA consisted of integrated sessions for physical rehabilitation/physiotherapy, psychology, and social work treatments. The control group received standard clinical practice treatment. The feasibility was assessed by the number of study procedures completed to at least 80% as planned. The impact on clinical practice was evaluated by the number of patients who changed their status from "candidate" to "non-candidate" to low back surgery as the treatment of choice for CNSLBP. The SF-36, Oswestry Disability Index, and TMMS-24 questionnaires were used. We performed a whole population-based descriptive analysis. RESULTS: We included 20 patients, but only 18 were randomized (2 withdrew consent before randomization). The mean (SD) age was 53.1 (5.9) years, and mostly women (13/18); 7 were actively employed. In the experimental group, 6/9 (67%, 95%CI:35-88%) patients attended at least 80% of the scheduled procedures, while in the control group, 8/9 (89%, 95%CI:57-98%) did. Additionally, 1 out of 4 (25%) patients in the experimental group changed their status from "candidate" for low back surgery to "non-candidate". None of the 2 patients in the control group did so. We found differences between groups in the SF-36 mental health component (p-value:0.061), Oswestry Disability Index (p-value:0.032), and TMMS-24 Repair component (p-value:0.014) at the end of the trial favoring MGVA. CONCLUSIONS: The multidisciplinary group videoconferencing approach to managing chronic non-specific low back pain was feasible, suggesting overall beneficial effects on patients' health and could play a role in changing a patient's status from "candidate" to "non-candidate" for surgery. TRIAL REGISTRATION: NCT05093543 (ClinicalTrials.gov), first registered in 26/10/2021.
Chronic Pain , Low Back Pain , Humans , Female , Middle Aged , Male , Low Back Pain/diagnosis , Low Back Pain/therapy , Low Back Pain/psychology , Treatment Outcome , Feasibility Studies , Physical Therapy Modalities , Aging , Chronic Pain/diagnosis , Chronic Pain/therapy
BACKGROUND: Surgical site infection (SSI) is one of the most frightening complications after surgery. Adhesive drapes (AD) are widely used as an infection prevention tool. They can be non-impregnated or iodophor-impregnated, although non-impregnated are less used as they might be related to higher number of infections. One of the most common ways to study their efficacy is by analyzing the intraoperative contamination, which is a useful primary endpoint as it does not need follow-up and it has been strongly associated with infections. Therefore, we believe a systematic review (SR) and meta-analysis is needed to determine which is the literature available about this topic and to explore their results. METHODS: All randomized controlled trials (RCT) published since 1984 through to January 15, 2023 will be included. Non-human and experimental studies will be excluded. We will only include studies written in English. We will conduct searches in the following electronic databases: MEDLINE (via PubMed), SCOPUS and Web Of Science. The protocol of the SR was registered in PROSPERO under the number CRD42023391651 and was written according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol guidelines. DISCUSSION: The evidence regarding the benefits of using iodophor-impregnated adhesive drapes (IIAD) is scarce. Therefore, this SR and meta-analysis is required to determine if they are related with a lower intraoperative contamination incidence, compared to no AD.
Adhesives , Surgical Drapes , Humans , Iodophors , Surgical Wound Infection/prevention & control , Surgical Wound Infection/epidemiology , Incidence , Systematic Reviews as Topic , Meta-Analysis as Topic
INTRODUCTION: Acute pancreatitis is a high-incidence benign disease. In 2009, it was the second highest cause of total hospital stays, the largest contributor to aggregate costs (approximately US$ 7000.00 per hospitalization), and the fifth leading cause of in-hospital deaths in the United States. Although almost 80% of acute pancreatitis cases are mild (usually requiring short-term hospitalization and without further complications), severe cases can be quite challenging.Classifications, scores, and radiological criteria have been developed to predict disease severity and outcome accurately; however, in-hospital care remains of widespread use, regardless of disease severity. A recent Turkish study reported that mild acute pancreatitis can be effectively and safely managed with home monitoring. Although the optimal timing for oral refeeding remains controversial and could cast some doubt on the feasibility of home monitoring, some guidelines already advocate for starting it within 24 hours.The present clinical trial aims to assess whether home monitoring is effective, safe and non-inferior to hospitalization for managing mild acute pancreatitis. METHODS: This will be a multicenter open-label randomized (1:1) controlled clinical trial to assess the efficacy and safety of home monitoring compared to in-hospital care for mild acute pancreatitis. All patients coming to the emergency department with suspected acute pancreatitis will be screened for enrollment. The main variable will be treatment failure (Yes/No) within the first 7 days after randomization. DISCUSSION: Acute pancreatitis implies a high economic burden in healthcare systems worldwide. Recent evidence suggests that mild disease can be safely and effectively treated with home monitoring. This approach may produce considerable cost savings and positively impact patients' quality of life. We expect the results to show that home monitoring is effective and not inferior to hospitalization for managing mild acute pancreatitis and that the economic costs are lower, kickstarting similar trials throughout the world, optimizing the use of limited healthcare budgets, and improving patients' quality of life.
Pancreatitis , Quality of Life , Humans , Acute Disease , Pilot Projects , Pancreatitis/diagnosis , Pancreatitis/therapy , Hospitalization
Introduction: Angiography with indocyanine green (ICG) fluorescence performed before thyroidectomy would allow identification of the vascularization of parathyroid glands, maximizing efforts for preserving functioning glands intraoperatively. The rationale of the study was based on the hypothesis that showing the vascular pattern of the parathyroid glands by means of ICG angiography before performing the thyroidectomy could prevent permanent hypoparathyroidism. Methods and analysis: We propose a randomized single-blind controlled and multicenter clinical trial to assess the efficacy and safety of ICG angiography-guided thyroidectomy to identify the vascular pattern of the parathyroid glands versus conventional thyroidectomy in patients scheduled for elective total thyroidectomy. Patients will be randomized 1:1 to ICG angiography-guided thyroidectomy (experimental group) or conventional thyroidectomy (control group). Patients in the experimental group will undergo ICG angiography before thyroidectomy to identify the feeding vessels of the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the glands. Patients in the control group will undergo post-thyroidectomy ICG angiography only. The primary outcome measure will be the rate of patients with permanent hypoparathyroidism. Secondary outcome measures will be rate of postoperative hypoparathyroidism, the percentage of well vascularized parathyroid glands remaining in situ, the levels of iPTH and serum calcium after surgery and the influence of the type of vascular pattern of the parathyroid glands over these outcomes, as well as the safety profile of ICG angiography. Discussion: The results will contribute to adopt a new surgical strategy based on intraoperative ICG angiography before performing total thyroidectomy, according to which the rate of permanent hypoparathyroidism could be substantially reduced. Clinical trial registration: ClinicalTrials.gov. identifier NCT05573828.
Hypoparathyroidism , Parathyroid Glands , Humans , Parathyroid Glands/diagnostic imaging , Parathyroid Glands/surgery , Indocyanine Green , Single-Blind Method , Thyroidectomy/adverse effects , Angiography , Hypoparathyroidism/etiology , Hypoparathyroidism/prevention & control , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
The study of sex differences in Alzheimer's disease is increasingly recognized as a key priority in research and clinical development. People with Down syndrome represent the largest population with a genetic link to Alzheimer's disease (>90% in the 7th decade). Yet, sex differences in Alzheimer's disease manifestations have not been fully investigated in these individuals, who are key candidates for preventive clinical trials. In this double-centre, cross-sectional study of 628 adults with Down syndrome [46% female, 44.4 (34.6; 50.7) years], we compared Alzheimer's disease prevalence, as well as cognitive outcomes and AT(N) biomarkers across age and sex. Participants were recruited from a population-based health plan in Barcelona, Spain, and from a convenience sample recruited via services for people with intellectual disabilities in England and Scotland. They underwent assessment with the Cambridge Cognitive Examination for Older Adults with Down Syndrome, modified cued recall test and determinations of brain amyloidosis (CSF amyloid-ß 42 / 40 and amyloid-PET), tau pathology (CSF and plasma phosphorylated-tau181) and neurodegeneration biomarkers (CSF and plasma neurofilament light, total-tau, fluorodeoxyglucose-PET and MRI). We used within-group locally estimated scatterplot smoothing models to compare the trajectory of biomarker changes with age in females versus males, as well as by apolipoprotein É4 carriership. Our work revealed similar prevalence, age at diagnosis and Cambridge Cognitive Examination for Older Adults with Down Syndrome scores by sex, but males showed lower modified cued recall test scores from age 45 compared with females. AT(N) biomarkers were comparable in males and females. When considering apolipoprotein É4, female É4 carriers showed a 3-year earlier age at diagnosis compared with female non-carriers (50.5 versus 53.2 years, P = 0.01). This difference was not seen in males (52.2 versus 52.5 years, P = 0.76). Our exploratory analyses considering sex, apolipoprotein É4 and biomarkers showed that female É4 carriers tended to exhibit lower CSF amyloid-ß 42/amyloid-ß 40 ratios and lower hippocampal volume compared with females without this allele, in line with the clinical difference. This work showed that biological sex did not influence clinical and biomarker profiles of Alzheimer's disease in adults with Down syndrome. Consideration of apolipoprotein É4 haplotype, particularly in females, may be important for clinical research and clinical trials that consider this population. Accounting for, reporting and publishing sex-stratified data, even when no sex differences are found, is central to helping advance precision medicine.
INTRODUCTION: Fiber is the initial treatment in chronic functional constipation. However, its role in the group of patients with defecatory dyssynergy is not well established. The objective of the study is to evaluate the efficacy and safety of a high fiber diet in patients with defecatory dyssynergy in the treatment with anorectal biofeedback. PATIENTS AND METHODS: An exploratory, randomized (1:1), double-blind, controlled «add-on¼ clinical trial was carried out in a reference center in Spain in patients with functional constipation and defecatory dyssynergy according to the ROMEIV criteria. CONTROL GROUP: treatment with biofeedback and low-fiber diet (15-20g/day). Experimental group: treatment with biofeedback and high fiber diet (25-30g/day). Analyzed: responder (primary endpoint), patient whose defecatory dyssynergy had been corrected (>20% reduction in anal pressure during the defecation maneuver and normal balloon expulsion test); anorectal parameters (anal relaxation, reduced straining); safety (abdominal symptoms: flatulence, pain, borborygmus, bloating). RESULTS: A total of 44 patients were randomized: 22 per group. The percentage of responders was 75% (15/20; 95%CI: 53 89%) control group and 70% (14/20; 95%CI: 48-85%) experimental group, P=.225. Differences in favor of the control group were only observed in abdominal symptoms: flatulence (P=.028), abdominal distension (P=.041) and digestive comfort (P=.043). CONCLUSIONS: In patients with defecatory dyssynergy, a high-fiber diet not only does not improve the efficacy of anorectal biofeedback but is associated with a loss of improvement in abdominal symptoms.
Defecation , Flatulence , Humans , Manometry , Constipation/etiology , Constipation/therapy , Constipation/diagnosis , Biofeedback, Psychology , Diet
BACKGROUND: We aimed to evaluate icatibant, a competitive antagonist of the bradykinin B2 receptors, for the treatment of inpatients with coronavirus disease 2019 (COVID-19) pneumonia admitted in the early hypoxemic stage. METHODS: The randomized, open-label clinical trial of icatibant for COVID-19 pneumonia (ICAT·COVID, registered as NCT04978051 at ClinicalTrials.gov) was conducted in Barcelona. Inpatients requiring supplemental but not high-flow oxygen or mechanical ventilation were allocated (1:1) to treatment with either three 30-mg icatibant doses/d for 3 consecutive days plus standard care or standard care alone, and followed for up to 28 days after initial discharge. The primary and key secondary outcomes were clinical response on study day 10/discharge and clinical efficacy at 28 days from initial discharge, respectively. RESULTS: Clinical response occurred in 27 of 37 patients (73.0%) in the icatibant group and 20 of 36 patients (55.6%) in the control group (rate difference, 17.42; 95% confidence interval [CI], -4.22 to 39.06; P = .115). Clinical efficacy ensued in 37 patients (100.0%) in the icatibant group and 30 patients (83.3%) in the control group (rate difference, 16.67; 95% CI, 4.49-28.84; P = .011). No patient died in the icatibant group, compared with 6 patients (16.7%) in the control group (P = .011). All patients but 1 had adverse events, which were evenly distributed between study arms. No patient withdrew because of adverse events. CONCLUSIONS: Adding icatibant to standard care was safe and improved both COVID-19 pneumonia and mortality in this proof-of-concept study. A larger, phase 3 trial is warranted to establish the clinical value of this treatment. CLINICAL TRIALS REGISTRATION: NCT04978051.
COVID-19 , Humans , Hospitalization , Inpatients , SARS-CoV-2 , Treatment Outcome , Proof of Concept Study
Aortoenteric fistula (AEF) is a low-prevalence, life-threatening condition regardless of treatment, with a 30-50% postoperative (≤60 days) mortality. This study aimed to estimate our postoperative cumulative mortality incidence and assess the feasibility of the diagnostic-therapeutic algorithm used in our clinical practice. We performed a retrospective cohort study of patients treated for AEF at a fully-equipped tertiary healthcare center between January 2008 and December 2020.
Aortic Diseases , Intestinal Fistula , Vascular Fistula , Humans , Retrospective Studies , Vascular Fistula/diagnostic imaging , Vascular Fistula/surgery , Aortic Diseases/diagnostic imaging , Aortic Diseases/surgery , Intestinal Fistula/surgery , Intestinal Fistula/etiology , Patient Care Team , Algorithms
INTRODUCTION: The profiles of patients with COVID-19 have been widely studied, but little is known about differences in baseline characteristics and in outcomes between subjects with a ceiling of care assigned at hospital admission and subjects without a ceiling of care. The aim of this study is to compare, by ceiling of care, clinical features and outcomes of hospitalized subjects during four waves of COVID-19 in a metropolitan area in Catalonia. METHODS: Observational study conducted during the first (March-April 2020), second (October-November 2020), third (January-February 2021), and fourth wave (July-August 2021) of COVID-19 in five centers of Catalonia. All subjects were adults (> 18 years old) hospitalized with a proven SARS-CoV-2 infection and with therapeutic ceiling of care assessed by the attending physician at hospital admission. RESULTS: A total of 5813 subjects were analyzed. Subjects with a ceiling of care were mainly older (difference in median age of 20 years), with more comorbidities (Charlson index 3 points higher) and with fewer clinical signs at baseline than patients without a ceiling of care. Some features of their clinical profiles changed among waves. There were differences in treatments received during hospital admission across waves, but not between subjects with and without a ceiling of care. Subjects with a ceiling of care had a death incidence more than four times the death incidence of subjects a without a ceiling of care (risk ratio (RR) ranging from 3.5 in the first wave to almost 6 in the third and fourth). Incidence of severe pneumonia and complications for subjects with a ceiling of care was around 1.5 times the incidence in subjects without a ceiling of care. DISCUSSION: Analysis of hospitalized subjects with SARS-CoV-2 infection should be stratified according to therapeutic ceiling of care to avoid bias and outcome misestimation.
