Protocolización de estudios clínicos multicéntricos en la era digital. ¿Tiene utilidad la centralización de datos por un data-manager? / Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

Introducción En los estudios multicéntricos la protocolización de los datos es una fase crítica que puede generar sesgos, sobre todo en estudios clínicos con presupuesto limitado. El objetivo es analizar la concordancia y la confiabilidad de los datos obtenidos en un estudio multicéntrico clínico entre la protocolización del centro de origen y la protocolización centralizada mediante un data-manager. Método Estudio clínico multicéntrico de prevalencia nacional sobre un carcinoma familiar infrecuente, realizándose una doble protocolización de los datos: a)en el centro de origen, y b)centralizada con un data-manager. La concordancia se analiza para el global de los datos y para los dos subgrupos del proyecto: a)grupo a estudio (carcinoma familiar; protocolizan 30 investigadores) y b)grupo control (carcinoma esporádico; protocolizan 4). Las diferencias interobservador se evalúan mediante el índice de Kappa de Cohen. Resultados Se incluyen 689 pacientes: 252 del grupo a estudio y 437 del grupo control. Respecto al análisis de concordancia del estadio tumoral, se han objetivado un 2,5% de discordancias, siendo alta la concordancia entre protocolizadores (Kappa=0,931). Respecto a la valoración del riesgo de recidiva, las discordancias fueron del 7% de los casos, siendo alta la concordancia (Kappa=0,819). Respecto a la clasificación ecográfica TIRADS, las discordancias son del 6,9% y la concordancia es alta (Kappa=0,922). Se han detectado un 4,6% de errores de transcripción. Conclusiones En los estudios multicéntricos clínicos la protocolización centralizada de los datos por un data-manager parece presentar resultados similares a la protocolización directa en la base de datos en el centro de origen. (AU)

Introduction In multicenter studies, the protocolization of data is a critical phase that can generate biases. The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data-manager. Methods National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (i)center of origin; and (ii)centralized by a data manager. The concordance between the data is analyzed for the global data and for the two groups of the project: (i)study group (familiar carcinoma, 30 researchers protocolize); (ii)control group (sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. Results The study includes a total of 689 patients with carcinoma: 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa=0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa=0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa=0.922). Also, 4.6% of transcription errors were detected. Conclusions In multicenter clinical studies, the centralized data protocolization by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin. (AU)

Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

INTRODUCTION: In multicenter studies, the protocolization of data is a critical phase that can generate biases.The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data -manager. METHODS: National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (a) center of origin; and (b) centralized by a data manager: The concordance between the data is analyzed for the global data and for the two groups of the project: (a) study group (Familiar carcinoma, 30 researchers protocolize); (b) control group (Sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. RESULTS: The study includes a total of 689 patients with carcinoma, 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa = 0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa = 0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa = 0.922). Also, 4.6% of transcription errors were detected. CONCLUSIONS: In multicenter clinical studies, the centralized data protocolization o by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin.

Advanced Lipoproteins and Lipidomic Profile in Plasma Determined by Nuclear Magnetic Resonance Before and After Bariatric Surgery.

BACKGROUND: Obesity is related to cardiovascular risk factors (CVRF) such as dyslipidemia, diabetes, and hypertension, which increase mortality. Basic lipid determinations could underestimate the true atherogenic risk of patients and the impact of bariatric surgery. The objective of the study is to demonstrate the change in the advanced molecular profile of lipoproteins determined by nuclear magnetic resonance spectroscopy in plasma after bariatric surgery, thus reducing the risk of cardiovascular disease. MATERIAL AND METHODS: Descriptive, observational, and prospective study in obese patients undergoing bariatric surgery. Advanced lipid profile was analyzed in plasma from the immediate preoperative period and at the 18th postoperative month by sending samples and performing plasma magnetic resonance spectroscopy in the BiosferTreslab® laboratory. RESULTS: Fifty-two patients were included. Average age of 46.3 years; 63.46% were women, 36.54% men. The average BMI was 43.57; the abdominal perimeter 133.50 cm; 32.6% were diabetics under medical treatment, 44.23% hypertensive, and 19.23% smokers; 86.53% of the patients presented alterations in at least one of the analytical parameters in the lipid study. Twenty-nine (55.7%) underwent banded gastric bypass (PGB), 19.23% underwent GBP, and 17.31% vertical gastrectomy. The rest were revision surgeries, two BPG-A and two biliopancreatic diversions after GV. All patients presented some improvement in advanced molecular profile of lipoproteins. Twenty percent of the patients normalized all the parameters. CONCLUSIONS: Bariatric surgery improves advanced molecular profile of lipoproteins, decreasing CVRF. Analysis of the characteristics of lipoprotein particles by NMR spectrometry is optimal for studying lipoprotein metabolism in patients undergoing bariatric surgery.

Evaluation of Mitochondrial Function in Blood Samples Shows Distinct Patterns in Subjects with Thyroid Carcinoma from Those with Hyperplasia.

Metabolic adaptations are a hallmark of cancer and may be exploited to develop novel diagnostic and therapeutic tools. Only about 50% of the patients who undergo thyroidectomy due to suspicion of thyroid cancer actually have the disease, highlighting the diagnostic limitations of current tools. We explored the possibility of using non-invasive blood tests to accurately diagnose thyroid cancer. We analyzed blood and thyroid tissue samples from two independent cohorts of patients undergoing thyroidectomy at the Hospital Universitario 12 de Octubre (Madrid, Spain). As expected, histological comparisons of thyroid cancer and hyperplasia revealed higher proliferation and apoptotic rates and enhanced vascular alterations in the former. Notably, they also revealed increased levels of membrane-bound phosphorylated AKT, suggestive of enhanced glycolysis, and alterations in mitochondrial sub-cellular distribution. Both characteristics are common metabolic adaptations in primary tumors. These data together with reduced mtDNA copy number and elevated levels of the mitochondrial antioxidant PRX3 in cancer tissue samples suggest the presence of mitochondrial oxidative stress. In plasma, cancer patients showed higher levels of cfDNA and mtDNA. Of note, mtDNA plasma levels inversely correlated with those in the tissue, suggesting that higher death rates were linked to lower mtDNA copy number. In PBMCs, cancer patients showed higher levels of PGC-1α, a positive regulator of mitochondrial function, but this increase was not associated with a corresponding induction of its target genes, suggesting a reduced activity in cancer patients. We also observed a significant difference in the PRDX3/PFKFB3 correlation at the gene expression level, between carcinoma and hyperplasia patients, also indicative of increased systemic metabolic stress in cancer patients. The correlation of mtDNA levels in tissue and PBMCs further stressed the interconnection between systemic and tumor metabolism. Evaluation of the mitochondrial gene ND1 in plasma, PBMCs and tissue samples, suggested that it could be a good biomarker for systemic oxidative metabolism, with ND1/mtDNA ratio positively correlating in PBMCs and tissue samples. In contrast, ND4 evaluation would be informative of tumor development, with ND4/mtDNA ratio specifically altered in the tumor context. Taken together, our data suggest that metabolic dysregulation in thyroid cancer can be monitored accurately in blood samples and might be exploited for the accurate discrimination of cancer from hyperplasia.

Ligamentum Teres Cardiopexy Might Not Prevent Gastro-esophageal Reflux After Laparoscopic Sleeve Gastrectomy: Case Series.

Roux-en-Y gastric bypass (RYGB) is considered the gold standard procedure in patients with obesity and gastroesophageal reflux (GERD), but in patients with preoperative hiatal hernia (HH) or GERD, who are unfit for RYGB, there are no clear guidelines. Ligamentum teres cardiopexy (LTC) has been proposed as an effective alternative. The purpose of this study was to analyze medium-term results of LTC procedure associated with laparoscopic sleeve gastrectomy (LSG) in patients with GERD or HH, according to the absence of pathologic acid reflux in esophageal 24 h pH monitoring test, symptom release, or PPI reduction. Five patients underwent LSG-LTC between March 2018 and October 2019. In one patient, the effectiveness of LTC as an anti-reflux procedure could not be assessed because of conversion to RYGB was required. After a follow-up period of 30 [24-42] months and excessive BMI loss of 62.74 ± 18.18%, GERD recurrence was observed in 75% of patients. The study was discontinued due to unsatisfactory preliminary results with LTC. Our results suggest that LTC might not prevent GERD after LSG in patients with preoperative GERD or HH.

Long-term outcomes of transanal total mesorectal excision for rectal cancer: what could we do to improve them?

BACKGROUND: Long-term outcomes of transanal mesorectal excision are still controversial. The aim of this study was to analyze long-term oncological and functional results of TaTME. METHODS: Fifty patients with mid-low rectal cancer were included: 20 underwent TaTME and 30 laparoscopic total mesorectal excision. Clinical characteristics of patients and tumors and quality indicators for rectal surgery were described. Long-term functional outcomes were compared in two groups (TaTME vs. laTME). Local recurrence rate was calculated. Kaplan-Meier curves were performed for disease-free and overall survival and log-rank test was used to compare two groups. RESULTS: There were not significant differences between two groups in sex, age ASA Score, neoadjuvant therapy, tumor stage and quality indicators of rectal surgery. After a median follow-up of 46 (41-51) months functional outcomes were significantly worse in TaTME group in terms of rates of maior low anterior resection syndrome score (10% vs. 0%, P=0.009), faucal incontinence (15% vs. 3%, P=0.017), urinary disfunction (10% vs. 0%, P=0.009) and sexual disfunction (15% vs. 13%, P=0.047). Only one patient presented local recurrence (TaTME group, ypT3N0). Overall survival at 1 and 3 years were 92.6% and 90% respectively and disease-free survival at 1 and 3 years were 96% and 90% respectively. There were not significant differences in overall survival and disease-free survival between two groups. CONCLUSIONS: Overall survival and disease-free survival after TaTME for rectal cancer were similar to laparoscopic total mesorectal excision. However functional outcomes were worse after TaTME.

Analysis of vaccination strategy against cystic echinococcosis developed in the Province of Río Negro, Argentina: 12 years of work.

Cystic echinococcosis (CE) is a zoonosis caused by species of the complex Echinococcus granulosus, sensu lato in their larval stage. It is an endemic disease in the province of Río Negro, where small farmers generally have both sheep and goats. Lamb vaccination with EG95 was incorporated in 2009 with very good results: in fact, it contributed to a significant drop in prevalence of infection in both sheep and goats, when determined by necropsy and serology in 2018. In the design of the activity, it was decided not to vaccinate goats in order to minimize the operational requirements of vaccination and comments from producers about the rarity of observing hydatid cysts in goat viscera were considered. OBJECTIVE: To identify causes which can still generate infection in dogs, and to detect species/genotypes in circulation in the province of Río Negro. MATERIALS AND METHODS: In indigenous reserves comprised within the area of lamb vaccination with 3 doses of EG95, (dose 1 in December, dose 2 in January and dose 3 in December of the year following, at the time of application of dose 1 to the new lambs). Prevalence in adult goats and sheep was determined by necropsy and serology (ELISA). Infective species/genotypes present in the work area and in the rest of the province of Río Negro were identified by Cox1 mitochondrial gene sequencing. Epidemiological analysis was completed with surveys among farmers about slaughter habits for human consumption. RESULTS: Through serology and necropsy, infection rates in vaccinated and nonvaccinated sheep were significantly different (21% versus 66%). Non-vaccinated sheep and non-vaccinated goats were also significantly different in that there was less infection in goats compared to sheep (7% versus 66% for necropsy, 30% versus 61% for serology); After many years of sheep vaccination the infection positives were low, and differences between vaccinated sheep and non-vaccinated goats turned out non-significant (21% versus 7%). With reference to epidemiology and control along the period 2018-2022, PZQ dosing of dogs 4 times a year was maintained, and 2 extra deworming tasks were introduced together with dose 1 and 2 of EG95, performed by the veterinary vaccination team, ensuring the ingestion of PZQ by dogs. Assessment of animal slaughter for consumption in 41 producers showed that 21 of them slaughter a monthly average of 18 goats (an average of 0.43 goat per month per farm) and 36 in all slaughter 35 old sheep in a year (average of 0.85 sheep per month per farm). With respect to identification of species/genotypes as from 2010, genotypes G1 have been found in 11 sheep (out of which 6 belong to vaccination zone) and genotypes G7, in one pig. A goat cyst within vaccination zone turned out unfertile and it was not possible to sequence it. CONCLUSION: Design and implementation of a vaccine programme combined with the use of PZQ resulted as cost-effective, since it was possible to maintain the vaccine over time, with clear impact on prevalence decrease in sheep and goats.

A cross-sectional study of free-roaming dogs in a Patagonian city: Their distribution and intestinal helminths in relation to socioeconomic aspects of neighborhoods.

Human and dog health are inextricably linked, and although our relationship with dogs brings numerous benefits for our well-being, it is known that they can transmit disease. Bariloche is a Patagonian tourist city with heterogeneous social composition. This cross-sectional study evaluates the population of free-roaming dogs and their intestinal parasites in relation to the socioeconomic level of the city's human population. Census areas were used as survey units, stratified in three levels according to socioeconomic status. The free-roaming dog population was estimated by walking around each census area. Eight fresh feces per census count area were collected and analyzed using coproparasitological flotation tests, and CoproELISA was used to detect Echinococcus sp. A total of 858 free-roaming dogs were registered along 40.9 km, with significant differences between socioeconomic strata: the highest numbers were found in the lowest income strata. Of the feces collected, 39.2% tested positive for parasites, those associated with a lower socioeconomic level having higher percentages of positive feces and a greater number of species. Eight species of helminths were found, some of which were zoonotic, such as Echinococcus sp., Toxocara canis, and Dibothriocephalus latus. The presence of parasites can be explained by the number of free-roaming dogs per census count area. The free-roaming dogs generally have owners, and their parasitic infection is strongly associated with the socioeconomic level of the population. The main problem is irresponsible pet care, which generates healthy conditions for both dogs and humans. Thus, both dogs and humans deserve effective ethical public policies.

Mechanical triangular esophagogastrostomy: Technical aspects and initial results.

INTRODUCTION: Esophageal cancer represents the eighth neoplasm worldwide. The therapeutic approach is interdisciplinary, with surgery being the most effective option. Several techniques have been proposed to perform esophagogastrostomy after esophagectomy, among them mechanical triangular esophagogastrostomy (MT), with a little experience published in the Western literature on the latter. The objective of this study is to describe the technical aspects and initial results of MT anastomosis. METHODS: A retrospective review of the patients who underwent esophagectomy according to the McKeown technique was performed, those in which MT anastomosis was implemented, between October 2017 and March 2020 in our hospital. RESULTS: 14 patients were included, with a mean age of 63 years. The mean operative time was 436 min (360-581), being diagnosed of anastomotic leak (AL) 3 of the 14 patients (21.4%), as well as 3 patients presented anastomotic stenosis (AS). The median stay was 20 days, without any death in the series. DISCUSSION: Multiple publications suggest the superiority in terms of AL and AS of the mechanical triangular anastomosis, which was also observed in our series, in which despite the small sample, a rapid improvement was observed in the indicators after the first cases. Therefore, this type of anastomosis may be a safe option for performing esophagogastric anastomosis after esophagectomy, being necessary more definitive conclusive studies.

Esofagogastrostomía triangular mecánica: aspectos técnicos y resultados iniciales / Mechanical triangular esophagogastrostomy: Technical aspects and initial results

IntroducciónEl cáncer de esófago representa la octava neoplasia a nivel mundial. El abordaje terapéutico es interdisciplinar y la cirugía es la opción más eficaz. Se han planteado varias técnicas para la realización de la esofagogastrostomía posterior a la esofagectomía, entre ellas, la esofagogastrostomía triangular mecánica, con muy poca experiencia publicada en la literatura occidental. El objetivo de este estudio es describir los aspectos técnicos y los resultados iniciales de la instauración de anastomosis triangular mecánica.MétodosSe realizó una revisión retrospectiva de los pacientes tratados mediante esofaguectomía según la técnica de McKeown, en los cuales se realizó anastomosis triangular mecánica entre octubre de 2017 y marzo de 2020 en nuestro hospital.ResultadosFueron incluidos 14 pacientes, con una media de edad de 63 años. El tiempo operatorio promedio fue de 436 min (360-581); fueron diagnosticados de fuga anastomótica 3 de los 14 pacientes (21,4%) y otros 3 pacientes presentaron estenosis anastomótica. La mediana de estancia fue de 20 días, sin ningún fallecimiento en la serie.ConclusionesMúltiples publicaciones señalan la superioridad en términos de fuga anastomótica y estenosis anastomótica de la anastomosis triangular mecánica. Esto también se observa en nuestra serie, en la cual, a pesar de lo reducido de la muestra, se observó una rápida mejoría en los indicadores posterior a los primeros casos, por lo que este tipo de anastomosis puede ser una opción segura para la confección de la anastomosis esofagogástrica posterior a la esofaguectomía. Son necesarios más estudios para alcanzar conclusiones definitivas (AU)

IntroductionEsophageal cancer represents the eighth neoplasm worldwide. The therapeutic approach is interdisciplinary, with surgery being the most effective option. Several techniques have been proposed to perform esophagogastrostomy after esophagectomy, among them mechanical triangular esophagogastrostomy, with a little experience published in the Western literature on the latter. The objective of this study is to describe the technical aspects and initial results of triangular esophagogastrostomy anastomosis.MethodsA retrospective review of the patients who underwent esophagectomy according to the McKeown technique was performed, those in which triangular esophagogastrostomy anastomosis was implemented, between October 2017 and March 2020 in our hospital.ResultsA total of 14 patients were included, with a mean age of 63 years. The mean operative time was 436minutes (360-581), being diagnosed of anastomotic leak 3 of the 14 patients (21.4%), as well as 3 patients presented anastomotic stenosis. The median stay was 20 days, without any death in the series.ConclusionsMultiple publications suggest the superiority in terms of anastomotic leak and anastomotic stenosis of the mechanical triangular anastomosis, which was also observed in our series, in which despite the small sample, a rapid improvement was observed in the indicators after the first cases. Therefore, this type of anastomosis may be a safe option for performing esophagogastric anastomosis after esophagectomy, being necessary more definitive conclusive studies (AU)

Predictive Power of the "Trigger Tool" for the detection of adverse events in general surgery: a multicenter observational validation study.

BACKGROUND: In spite of the global implementation of standardized surgical safety checklists and evidence-based practices, general surgery remains associated with a high residual risk of preventable perioperative complications and adverse events. This study was designed to validate the hypothesis that a new "Trigger Tool" represents a sensitive predictor of adverse events in general surgery. METHODS: An observational multicenter validation study was performed among 31 hospitals in Spain. The previously described "Trigger Tool" based on 40 specific triggers was applied to validate the predictive power of predicting adverse events in the perioperative care of surgical patients. A prediction model was used by means of a binary logistic regression analysis. RESULTS: The prevalence of adverse events among a total of 1,132 surgical cases included in this study was 31.53%. The "Trigger Tool" had a sensitivity and specificity of 86.27% and 79.55% respectively for predicting these adverse events. A total of 12 selected triggers of overall 40 triggers were identified for optimizing the predictive power of the "Trigger Tool". CONCLUSIONS: The "Trigger Tool" has a high predictive capacity for predicting adverse events in surgical procedures. We recommend a revision of the original 40 triggers to 12 selected triggers to optimize the predictive power of this tool, which will have to be validated in future studies.

Quality indicators of transanal total mesorectal excision (TaTME) for rectal cancer

Introduction: Transanal total mesorectal excision (TaTME) has revolutionized the surgical techniques for lower-third rectal cancer. The aim of the present study was to analyze the outcomes of quality indicators of TaTME for rectal cancer compared with laparoscopic TME (LaTME). Methods: A cohort prospective study with 50 (14 female and 36male) patients, with a mean age of 67 (range: 55.75 to 75.25) years, who underwent surgery for rectal cancer. In total, 20 patients underwent TaTME, and 30, LaTME. Every TaTME procedure was performed by experienced colorectal surgeons. The sample was divided into two groups (TaTME and LaTME), and the quality indicators of the surgery for rectal cancer were analyzed. Results: There were no statistically significant differences regarding the patients and the main characteristics of the tumor (age, gender, American Society of Anesthesiologists [ASA] score, body mass index [BMI], tumoral stage, neoadjuvant therapy, and distance from the tumor to the external anal margin) between the two groups. The rates of: postoperativemorbidity (TaTME: 35%; LaTME: 30%; p=0.763);mortality (0%); anastomotic leak (TaTME: 10%; LaTME: 13%; p=0.722); wound infection (TaTME: 0%; LaTME: 3.3%; p=0.409); reoperation (TaTME: 5%; LaTME: 6.6%; p=0.808); and readmission (TaTME: 5%; LaTME: 0%; p=0.400), as well as the length of the hospital stay (TaTME: 13.5 days; LaTME: 11 days; p=0.538), were similar in both groups. There were no statistically significant differences in the rates of positive circumferential resection margin (TaTME: 5%; LaTME: 3.3%; p=0.989) and positive distal resection margin (TaTME: 0%; LaTME: 3.3%; p=0.400), the completeness of the TME (TaTME: 100%; LaTME: 100%), and the number of lymph nodes harvested (TaTME: 15; LaTME: 15.5; p=0.882) between two groups. Conclusion: Transanal total mesorectal excision is a safe and feasible surgical procedure for middle/lower-third rectal cancer. (AU)

Impact of the Covid-19 pandemic on colorectal cancer surgery in Madrid

Introduction: The Covid-19 pandemic has had an important impact on colorectal cancer surgery, for hospital resources had to be redistributed in favour of Covid-19 patients. The aim of the present study is to analyze our results in colorectal oncologic surgery during the Covid-19 pandemic in patients with and without perioperative SARSCoV- 2 infection. Methods: In total, 32 patients (19 male and 13 female patients), with a mean age of 64 years (range: 57.2 to 69.5 years) with colorectal cancer underwent surgery under the recommendations of surgical societies included in a protocol. Data collection included clinical characteristics (gender, age, body mass index, American Society of Anesthesiologists score, tumor location, preoperative staging, lymphopenia), data related to SARS-CoV-2 infection (postoperative symptoms, diagnostic tests), operative details (surgical procedure, approach, duration, stoma), pathological outcomes (tumor stage, number of lymph nodes harvested, distal and circumferential radial margins, quality of the total mesorectal excision), and surgical outcomes (morbidity, mortality, hospital stay, and the rates of reoperation and readmission). Results: A total of 3 (9.4%) patients who underwent colorectal surgery during the Covid-19 pandemic were infected by SARS-CoV-2 in the postoperative period. Chronic obstructive pulmonary disease was associated with Covid-19 (6.2% versus 33.3%; p=0.042), and surgical morbidity was higher among Covid-19 patients (100% versus 37.9%; p=0.039). There were not significant differences between COVID-19 patients and non-COVID-19 patients in relation to the rest of the analyzed outcomes. Conclusion: During the Covid-19 pandemic, colorectal cancer surgery should be performed according to the recommendations of surgical societies. However, Covid- 19 patients could present a higher morbidity rate. (AU)

Multicentre cohort study of acute cholecystitis management during the COVID-19 pandemic.

PURPOSE: To analyse acute cholecystitis (AC) management during the first pandemic outbreak after the recommendations given by the surgical societies estimating: morbidity, length of hospital stay, mortality and hospital-acquired SARS-CoV-2 infection rate. METHODS: Multicentre-combined (retrospective-prospective) cohort study with AC patients in the Community of Madrid between 1st March and 30th May 2020. 257 AC patients were involved in 16 public hospital. Multivariant binomial logistic regression (MBLR) was applied to mortality. RESULTS: Of COVID-19 patients, 30 were diagnosed at admission and 12 patients were diagnosed during de admission or 30 days after discharge. In non-COVID-19 patients, antibiotic therapy was received in 61.3% of grade I AC and 40.6% of grade II AC. 52.4% of grade III AC were treated with percutaneous drainage (PD). Median hospital stay was 5 [3-8] days, which was higher in the non-surgical treatment group with 7.51 days (p < 0.001) and a 3.25% of mortality rate (p < 0.21). 93.3% of patients with SARS-CoV-2 infection at admission were treated with non-surgical treatment (p = 0.03), median hospital stay was 11.0 [7.5-27.5] days (p < 0.001) with a 7.5% of mortality rate (p > 0.05). In patients with hospital-acquired SARS-CoV-2 infection, 91.7% of grade I-II AC were treated with non-surgical treatment (p = 0.037), with a median hospital stay of 16 [4-21] days and a 18.2% mortality rate (p > 0.05). Hospital-acquired infection risk when hospital stay is > 7 days is OR 4.7, CI 95% (1.3-16.6), p = 0.009. COVID-19 mortality rate was 11.9%, AC severity adjusted OR 5.64 (CI 95% 1.417-22.64). In MBLR analysis, age (OR 1.15, CI 95% 1.02-1.31), SARS-CoV-2 infection (OR 14.49, CI 95% 1.33-157.81), conservative treatment failure (OR 8.2, CI 95% 1.34-50.49) and AC severity were associated with an increased odd of mortality. CONCLUSION: In our population, during COVID-19 pandemic, there was an increase of non-surgical treatment which was accompanied by an increase of conservative treatment failure, morbidity and hospital stay length which may have led to an increased risk hospital-acquired SARS-CoV-2 infection. Age, SARS-CoV-2 infection, AC severity and conservative treatment failure were mortality risk factors.

Mechanical triangular esophagogastrostomy: Technical aspects and initial results. / Esofagogastrostomía triangular mecánica: aspectos técnicos y resultados iniciales.

INTRODUCTION: Esophageal cancer represents the eighth neoplasm worldwide. The therapeutic approach is interdisciplinary, with surgery being the most effective option. Several techniques have been proposed to perform esophagogastrostomy after esophagectomy, among them mechanical triangular esophagogastrostomy, with a little experience published in the Western literature on the latter. The objective of this study is to describe the technical aspects and initial results of triangular esophagogastrostomy anastomosis. METHODS: A retrospective review of the patients who underwent esophagectomy according to the McKeown technique was performed, those in which triangular esophagogastrostomy anastomosis was implemented, between October 2017 and March 2020 in our hospital. RESULTS: A total of 14 patients were included, with a mean age of 63 years. The mean operative time was 436minutes (360-581), being diagnosed of anastomotic leak 3 of the 14 patients (21.4%), as well as 3 patients presented anastomotic stenosis. The median stay was 20 days, without any death in the series. CONCLUSIONS: Multiple publications suggest the superiority in terms of anastomotic leak and anastomotic stenosis of the mechanical triangular anastomosis, which was also observed in our series, in which despite the small sample, a rapid improvement was observed in the indicators after the first cases. Therefore, this type of anastomosis may be a safe option for performing esophagogastric anastomosis after esophagectomy, being necessary more definitive conclusive studies.