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.

La población gitana tiene miedos sobre la donación de órganos propios para trasplante / The Roma population's fear of donating their own organs for transplantation

Introducción: La tasa de negativas a la donación entre el pueblo gitano es muy superior a la de cualquier otro grupo social. Objetivo: Analizar la actitud hacia la donación de los órganos propios entre la población gitana residente en España. Métodos: Tipo de estudio: estudio sociológico observacional nacional español estratificado por género y edad. Población a estudio: población gitana con edad≥15 años residente en España. Tamaño muestral: 1.253 encuestados. Instrumento de valoración: cuestionario validado de actitud hacia la donación de órganos para trasplante PCID-DTO Ríos. Trabajo de campo: selección aleatoria en función de la estratificación. Cumplimentación anónima y autoadministrada. Fue precisa la colaboración de personas de etnia gitana. Estadística: test de t de Student, χ2, Fisher y un análisis de regresión logística. Resultados: El grado de cumplimentación fue del 18,2% (n=228). De los que han cumplimentado el cuestionario, están a favor de la donación el 42,1% (n=96), indeciso el 30,3% (n=69) y en contra el 27,6% restante (n=63). De los 1.025 (81,8%) que rechazaron cumplimentar el cuestionario, 1.004 (98%) indicaron que era por miedo a hablar y rellenar un cuestionario que plantee el tema de la muerte y la donación de órganos tras fallecer. Si se considera que los que no han cumplimentado el cuestionario por miedo a la muerte y la donación de órganos tras fallecer no están a favor, los resultados serían los siguientes: el 7,8% (n=96) a favor de donar sus órganos frente al 92,2% (n=1.136) no a favor (en contra o indecisos). Conclusiones: La población gitana presenta un rechazo mayoritario a plantear el tema de la muerte y la donación de órganos tras fallecer. Estos hallazgos muestran que las campañas actuales para promover la donación de órganos no son efectivas en este grupo de población. (AU)

Introduction: The refusal rate for donating organs among the Roma people is much higher than that of any other social group. Objective: To analyze the attitude towards the donation of one's own organs among the Roma population living in Spain. Methods: Type of study: Spanish national observational sociological study stratified by gender and age. Study population: Roma population aged≥15 years living in Spain. Sample size: 1253 respondents. Assessment instrument: validated questionnaire on attitude towards organ donation for transplantation PCID-DTO Ríos. Field work: random selection based on stratification. Anonymous and self-administered completion. The collaboration of people of Roma ethnicity was required. Statistics: Student's t test, χ2, Fisher's exact test and a logistic regression analysis. Results: The degree of completion was 18.2% (n=228). Of those who completed the questionnaire, 42.1% (n=96) were in favor of donation, 30.3% (n=69) were undecided and the remaining 27.6% (n=63) were against it. Of the 1025 (81.8%) who declined to complete the questionnaire, 1004 (98%) indicated that it was for fear of speaking about and filling in a questionnaire that raises the issue of death and organ donation after death. If those who did not complete the questionnaire due to fear of death and donating organs after death are considered not in favor, the results would be as follows: 7.8% (n=96) in favor of donating their organs compared to 92.2% (n=1136) not in favor (against or undecided). Conclusions: A majority of the Roma population prefer not speak of death nor organ donation after death. These findings show that current campaigns to promote organ donation are not effective in this population group. (AU)

Lower limb cutaneous melanoma surgery: location matters.

The anatomical location of cutaneous melanoma is a relevant independent prognostic factor in melanoma. The aim of the study is to know the prognosis of lower limb cutaneous melanoma related to their location within the limb, regardless of the histological type, and if there are any other influencing variables. A real-world data observational study was developed. The lesions were divided depending on the location of the melanoma (thigh, leg and foot). Bivariate and multivariate analysis were performed, and melanoma-specific survival and disease-free survival rates were calculated. When these analysis were done, the results showed that, in melanomas of the lower limb, location on the foot presented a lower melanoma-specific survival rate compared to more proximal locations, and only the anatomical location presents statistical significance to discriminate cases with a higher mortality risk and a lower disease-free survival rate among distal melanomas (mainly on the foot). In conclusion, this study confirms that a more distal location of lower limb cutaneous melanoma is a relevant prognostic factor.Trial registration number NCT04625491 retrospectively registered.

The Roma population's fear of donating their own organs for transplantation.

BACKGROUND: The refusal rate for donating organs among the Roma people is much higher than that of any other social group. OBJECTIVE: To analyze the attitude towards the donation of one's own organs among the Roma population living in Spain. METHOD: . TYPE OF STUDY: Spanish national observational sociological study stratified by gender and age. STUDY POPULATION: Roma population aged ≥15 years living in Spain. SAMPLE SIZE: 1,253 respondents. Assessment instrument: Validated questionnaire on attitude towards organ donation for transplantation "PCID - DTO Ríos". Field work: Random selection based on stratification. Anonymous and self-administered completion. The collaboration of people of Roma ethnicity was required. STATISTICS: Student's t test, χ2, Fisher's exact test and a logistic regression analysis. RESULTS: The degree of completion was 18.2% (n = 228). Of those who completed the questionnaire, 42.1% (n = 96) were in favor of donation, 30.3% (n = 69) were undecided and the remaining 27.6% (n = 63) were against it. Of the 1,025 (81.8%) who declined to complete the questionnaire, 1,004 (98%) indicated that it was for fear of speaking about and filling in a questionnaire that raises the issue of death and organ donation after death. If those who did not complete the questionnaire due to fear of death and donating organs after death are considered not in favor, the results would be as follows: 7.8% (n = 96) in favor of donating their organs compared to 92.2% (n = 1166) not in favor (against or undecided). CONCLUSIONS: A majority of the Roma population prefer not speak of death nor organ donation after death. These findings show that current campaigns to promote organ donation are not effective in this population group.

[Influence of the lockdown due to COVID-19 on weight-loss results during the first year after sleeve gastrectomy]. / Influencia del confinamiento por COVID-19 en los resultados ponderales durante el primer año tras la gastrectomía vertical.

INTRODUCTION: COVID-19 pandemic has lead to lockdown of population in many countries. In Spain, the state of alarm was established from March 15 to June 20, 2020. Usually this fact decreased people's mobility and physical activity, in addition to producing or exacerbating psychological disorders. Our aim was to determine the influence that this condition had over the short-term ponderal results of patients undergoing laparoscopic vertical gastrectomy from May 2019 to May 2020. METHODS: Case-control study for comparing the percentage of excess weight lost (%EWL) and the percentage of total weight lost (%TWL) of patients that underwent a VG during the last year, so they were affected by lockdown in April and part of March 2020 (group 1), to the %EWL and %TWL of a control group (group 2), obtained from our previous series. RESULTS: The mean %EWL in group 1 is 47,37 ± 18,59 and in group 2 is 51,13 ± 17,59, being p = 0,438. Meanwhile, the mean %TWL in group 1 is 21,14 ± 8,17 and in group 2 is 24,67 ± 8,01, with p = 0,115. CONCLUSIONS: Population lockdown by COVID-19 did not get worse short-term results of vertical gastrectomy. More studies with a larger number of patients are necessary to draw firm conclusions.

Clinical value of baseline 18F-FDG PET/CT in soft tissue sarcomas.

BACKGROUND: The use of 18F-FDG Positron emission tomography/Computed tomography (PET/CT) in the initial staging of many cancers is clearly established. Most soft tissue sarcoma (STS) has a high affinity for 18F-FDG, which is why 18F-FDG PET/CT has been proposed as a non-invasive method, useful in diagnosis and follow-up. The standardized uptake value values (SUV), the volume-based metabolic parameters MTV (metabolic tumor volume), and TLG (total lesion glycolysis) determine tumor viability and provide its total volume and the total activity of metabolically active tumor cells. The histological grade is the most important predictor of metastases and mortality associated with STS, and a significant relationship between the metabolic parameters of 18F-FDG PET/CT and the histological grade has been described. METHODS: A retrospective study was conducted on STS patients, who had histological grade according to the FNCLCC (Fédération Nationale des Centres de Lutte Contre Le Cancer) criteria, as well as a baseline PET/CT. SUV (SUVmax, SUVmean, and SUVpeak), MTV, and TLG were quantified. A T-student test was performed to establish the relationship between the metabolic biomarkers and the histological grade. Their usefulness as predictors of the histological grade was verified using receiver operator characteristic (ROC) curves. A survival function study was performed using the Kaplan-Meier method. To assess the prognostic utility of the metabolic biomarkers we use the Log-Rank method. RESULTS: The SUV values were useful to discriminate high-grade STS. We found a significant relationship between the histological grade and the SUV values. SUVmax, SUVpeak, MTV, and TLG were predictors of overall survival (OS). There were no significant differences in the OS for the SUVmean, or in the disease-free survival (DFS) for SUVmax, SUVmean, SUVpeak, MTV, and TLG. CONCLUSIONS: The SUVmax, SUVmean, and SUVpeak values correlate with the HG and are useful to discriminate high-grade from low-grade STS. Patients with high SUVmax, SUVpeak, MTV, and TLG have a significantly lower OS.

Usefulness of an organ donation opinion survey as a tool to promote organ donation among the adolescent population.

Opinion surveys on health issues are considered health promotion tools. However, no studies have confirmed this in deceased organ donation for transplantation. This study aimed to analyse the impact of completing an opinion questionnaire about deceased organ donation on the attitude towards organ donation among the adolescent population. This longitudinal study with repeated measurements of attitude towards deceased organ donation was conducted with an adolescent population. The measurement instrument was a validated questionnaire of the attitude towards organ donation (PCID-DTO-Ríos). The study process involved the application of the questionnaire at an initial time, 1 month later, and 6 months later. A total of 1374 adolescents participated in this study. The favourable attitude towards donation was 43.1%, which fell to 41.4% at 1 month (P = 0.145), and to 39.7% at 6 months (P = 0.019). Changes in the attitude were observed in all groups, both 1 and 6 months after the questionnaire was completed. There was no objective relationship between the adolescent's socio-family environment and the effect of completing the questionnaire on their attitude towards deceased organ donation. In conclusion, the opinion questionnaire was not useful for promoting organ donation and did not have a positive effect on adolescents' attitudes towards organ donation in the medium or long term.

Cavity shaving for invasive breast cancer conservative surgery: Reduced specimen volume and margin positive rates.

INTRODUCTION: The cavity shaving (CS) technique was described in breast conserving surgery to reduce the rate of reoperation avoiding the need for intraoperative margin analysis. This study assesses differences in the rates of involvement of the surgical margin (requiring further surgery) and volume of surgical specimens, depending on the use or not of this technique. MATERIAL AND METHODS: A retrospective cohort study was conducted in patients with breast carcinoma who underwent breast conserving surgery between 2013 and 2019. They were divided into two groups depending on whether the cavity shaving technique was used or not. Primary outcomes of the study included presence of final margin involvement, requiring need for further surgery, and the volume of excised tissue comparing the study groups. RESULTS: A total of 202 cases were included: 92 in the control group and 110 in the cavity shaving group. Significant differences were found regarding involvement of the final margin (19.57% control group vs. 4.55% cavity shaving group; p = 0.010). The volume of additional surgical specimens were significantly greater in the traditional technique group than in the shaving technique (46.43 vs 13.32 cm3; p = 0.01) as was total specimen volume (143.40 vs 100.63 cm3; p = 0.022). CONCLUSIONS: CS can reduce the positive margin and re-excision rates without larger-volume resections and should therefore be considered a routine technique in BCS for early-stage breast cancer.

Influencia del confinamiento por COVID-19 en los resultados ponderales durante el primer año tras la gastrectomía vertical / Influence of the lockdown due to COVID-19 on weight-loss results during the first year after sleeve gastrectomy

Introducción: La pandemia por COVID-19ha obligado al confinamiento de la población en muchos países. En España, el estado de alarma se estableció desde el 15 de marzo al 20 de junio del 2020. Este hecho, por lo general, disminuyó la movilidad y la actividad física de las personas, además de producir o exacerbar alteraciones psicológicas. Nuestro objetivo es analizar la influencia que esta situación ha ejercido sobre los resultados ponderales a corto plazo de los pacientes tratados mediante una gastrectomía vertical laparoscópica entre mayo del 2019 y mayo del 2020. Métodos: Estudio de casos y controles donde se compararon el porcentaje de exceso de peso perdido (%EWL) y el porcentaje de peso total perdido (%TWL) de los pacientes intervenidos en el último año y a los que ha afectado el confinamiento durante el mes de abril y parte de marzo del 2020 (grupo 1; n=20), con el de un grupo control (grupo 2; n=40) de nuestra casuística previa. Resultados: El %EWL medio en el grupo 1 es de 47,37±18,59 y en el grupo 2 es de 51,13±17,59, siendo la p=0,438. Por su parte, el %TWL medio en el grupo 1 es de 21,14±8,17 mientras que en el grupo 2 es de 24,67±8,01, resultando la p=0,115. Conclusiones: El confinamiento de la población por COVID-19 no empeoró los resultados ponderales a corto plazo de la gastrectomía vertical. Son necesarios más estudios con un mayor número de pacientes para obtener conclusiones más sólidas. (AU)

Introduction: COVID-19 pandemic has lead to lockdown of population in many countries. In Spain, the state of alarm was established from March 15 to June 20, 2020. Usually this fact decreased people's mobility and physical activity, in addition to producing or exacerbating psychological disorders. Our aim was to determine the influence that this condition had over the short-term ponderal results of patients undergoing laparoscopic vertical gastrectomy from May 2019 to May 2020. Methods: Case-control study for comparing the percentage of excess weight lost (%EWL) and the percentage of total weight lost (%TWL) of patients that underwent a VG during the last year, so they were affected by lockdown in April and part of March 2020 (group 1), to the %EWL and %TWL of a control group (group 2), obtained from our previous series. Results: The mean %EWL in group 1 is 47,37±18,59 and in group 2 is 51,13±17,59, being p=0,438. Meanwhile, the mean %TWL in group 1 is 21,14±8,17 and in group 2 is 24,67±8,01, with p=0,115. Conclusions: Population lockdown by COVID-19 did not get worse short-term results of vertical gastrectomy. More studies with a larger number of patients are necessary to draw firm conclusions. (AU)

Influence of the lockdown due to COVID-19 on weight-loss results during the first year after sleeve gastrectomy.

INTRODUCTION: COVID-19 pandemic has lead to lockdown of population in many countries. In Spain, the state of alarm was established from March 15 to June 20, 2020. Usually this fact decreased people's mobility and physical activity, in addition to producing or exacerbating psychological disorders. Our aim was to determine the influence that this condition had over the short-term ponderal results of patients undergoing laparoscopic vertical gastrectomy from May 2019 to May 2020. METHODS: Case-control study for comparing the percentage of excess weight lost (%EWL) and the percentage of total weight lost (%TWL) of patients that underwent a VG during the last year, so they were affected by lockdown in April and part of March 2020 (group 1), to the %EWL and %TWL of a control group (group 2), obtained from our previous series. RESULTS: The mean %EWL in group 1 is 47.37±18.59 and in group 2 is 51.13±17.59, being P=.438. Meanwhile, the mean %TWL in group 1 is 21.14±8.17 and in group 2 is 24.67±8.01, with P=.115. CONCLUSIONS: Population lockdown by COVID-19 did not get worse short-term results of vertical gastrectomy. More studies with a larger number of patients are necessary to draw firm conclusions.

Is the result of breast Tc-99m mibi scintigraphy a prognostic factor for survival in invasive breast cancer? / ¿Es el resultado de la gammagrafía con Tc-99m MIBI un factor pronóstico para la supervivencia en el cáncer invasor de mama?

Background Breast scintigraphy with Tc-99m MIBI showed utility in diagnosing and monitoring response to neoadjuvant treatment. This work studies if there are differences in long-term survival in breast carcinomas depending on the result of Tc-99 MIBI scintigraphy and to analyze their relationship with other variables of prognostic value. Material and methods A prospective observational study on a series of cases of breast cancer in which scintigraphy with Tc-99m MIBI was carried out prior to its treatment, and which had a minimum follow-up of ten years. Clinical–epidemiological, histopathological and immunohistochemical variables were recorded. Bivariate and multivariate analysis were performed studying the result of Tc99m-MIBI scintigraphy. Differences in OS and DFS were studied using Kaplan Meier curves with the log-rank test between factors. Results The significant relationship was found between Tc-99m-MIBI positive result and palpable tumors (p=0.0001), poorly differentiated (p=0.003), with lymph node involvement (p=0.038) and high cell proliferation (p=0.007), although only the palpability and tumor size are related after multivariate analysis. Patients with Tc-99m MIBI positive tumors showed a worse OS (p=0.043) and DFS (p=0.026), independently of size and palpability of the lesión. Conclusion Tc-99m MIBI scintigraphy showed prognostic importance in invasive breast cancer, relating its positivity to reduced long-term survival. (AU)

Introducción La gammagrafía mamaria con Tc-99m MIBI ha mostrado su utilidad en el diagnóstico y la monitorización de la respuesta al tratamiento neoadyuvante. Este trabajo estudia si hay diferencias en la supervivencia por cáncer de mama a largo plazo dependiendo del resultado de la gammagrafía con Tc-99m MIBI y analizar su relación con otras variables de valor pronóstico. Material y métodos Se realizó un estudio observacional prospectivo sobre una serie de pacientes con cáncer de mama en las que se realizó una gammagrafía con Tc-99m MIBI previa a su tratamiento, y con un seguimiento mínimo de 10 años. Se registraron variables clínico-epidemiológicas, histopatológicas e inmunohistoquímicas. Se realizaron análisis bivariante y multivariante para el resultado de la gammagrafía con Tc-99m MIBI. Se estudiaron la supervivencia glogal y libre de enfermedad mediante la curva de Kaplan-Meier y el test de log-rank entre factores. Resultados Se encontró una relación significativa entre la gammagrafía con Tc-99m MIBI positiva y las lesiones palpables (p=0,0001), pobremente diferenciadas (p=0,003), con afectación ganglionar (p=0,038) y alta proliferación celular (p=0,007), aunque solo la palpabilidad y el tamaño tumoral fueron significativos en el análisis multivariante. Las pacientes con gammagrafía positiva mostraron peor supervivencia global (p=0,043) y libre de enfermedad (p=0,026), independientemente del tamaño o la palpabilidad de la lesión. Conclusión La gammagrafía mamaria con Tc-99m MIBI presenta una relevancia pronóstica en cáncer invasor de mama, relacionando su positividad con menor supervivencia a largo plazo. (AU)

Influencia del confinamiento por COVID-19 en los resultados ponderales durante el primer año tras la gastrectomía vertical / Influence of the lockdown due to COVID-19 on ponderal results during the first year after vertical gastrectomy

INTRODUCCIÓN: La pandemia por COVID-19ha obligado al confinamiento de la población en muchos países. En España, el estado de alarma se estableció desde el 15 de marzo al 20 de junio del 2020. Este hecho, por lo general, disminuyó la movilidad y la actividad física de las personas, además de producir o exacerbar alteraciones psicológicas. Nuestro objetivo es analizar la influencia que esta situación ha ejercido sobre los resultados ponderales a corto plazo de los pacientes tratados mediante una gastrectomía vertical laparoscópica entre mayo del 2019 y mayo del 2020. MÉTODOS: Estudio de casos y controles donde se compararon el porcentaje de exceso de peso perdido (%EWL) y el porcentaje de peso total perdido (%TWL) de los pacientes intervenidos en el último año y a los que ha afectado el confinamiento durante el mes de abril y parte de marzo del 2020 (grupo 1; n = 20), con el de un grupo control (grupo 2; n = 40) de nuestra casuística previa. RESULTADOS: El %EWL medio en el grupo 1 es de 47,37 ± 18,59 y en el grupo 2 es de 51,13 ± 17,59, siendo la p = 0,438. Por su parte, el %TWL medio en el grupo 1 es de 21,14 ± 8,17 mientras que en el grupo 2 es de 24,67 ± 8,01, resultando la p = 0,115. CONCLUSIONES: El confinamiento de la población por COVID-19 no empeoró los resultados ponderales a corto plazo de la gastrectomía vertical. Son necesarios más estudios con un mayor número de pacientes para obtener conclusiones más sólidas

INTRODUCTION: COVID-19 pandemic has lead to lockdown of population in many countries. In Spain, the state of alarm was established from March 15 to June 20, 2020. Usually this fact decreased people's mobility and physical activity, in addition to producing or exacerbating psychological disorders. Our aim was to determine the influence that this condition had over the short-term ponderal results of patients undergoing laparoscopic vertical gastrectomy from May 2019 to May 2020. METHODS: Case-control study for comparing the percentage of excess weight lost (%EWL) and the percentage of total weight lost (%TWL) of patients that underwent a VG during the last year, so they were affected by lockdown in April and part of March 2020 (group 1), to the %EWL and %TWL of a control group (group 2), obtained from our previous series

Relationship between the polyp detection rate and the post-colonoscopy colorectal cancer rate

Aim: the adenoma detection rate is the quality indicator of colonoscopy that is most closely related to the development of interval colorectal cancer or post-colonoscopy colorectal cancer. However, the recording of this indicator in different units of gastrointestinal endoscopy is obstructed due to the large consumption of resources required for its calculation. Several alternatives have been proposed, such as the polyp detection rate. The objective of this study was to evaluate the relationship between the polyp detection rate and its influence on post-colonoscopy colorectal cancer rate. Patients and methods: in this study, 12,482 colonoscopies conducted by 14 endoscopists were analyzed. The polyp detection rate was calculated for each endoscopist. Endoscopists were grouped into quartiles (Q1, Q2, Q3, and Q4), from lowest to highest polyp detection rate, in order to evaluate whether there were any differences in the development of post-colonoscopy colorectal cancer. Results: the lowest polyp detection rate was 20.66% and the highest was 52.16%, with a median of 32.78 and a standard deviation of +/- 8.54. A strong and positive association between polyp endoscopy diagnosis and adenoma histopathology result was observed and a linear regression was performed. A significantly higher post-colonoscopy colorectal cancer rate was observed in the group of endoscopists with a lower polyp detection rate (p < 0.02). Conclusion: polyp detection rate is a valuable quality indicator of colonoscopy and its calculation is much simpler than that of the adenoma detection rate. In our study, the prevalence of post-colonoscopy colorectal cancer was inversely and significantly related to the endoscopists' polyp detection rate

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Relationship between the polyp detection rate and the post-colonoscopy colorectal cancer rate.

AIM: the adenoma detection rate is the quality indicator of colonoscopy that is most closely related to the development of interval colorectal cancer or post-colonoscopy colorectal cancer. However, the recording of this indicator in different units of gastrointestinal endoscopy is obstructed due to the large consumption of resources required for its calculation. Several alternatives have been proposed, such as the polyp detection rate. The objective of this study was to evaluate the relationship between the polyp detection rate and its influence on post-colonoscopy colorectal cancer rate. PATIENTS AND METHODS: in this study, 12,482 colonoscopies conducted by 14 endoscopists were analyzed. The polyp detection rate was calculated for each endoscopist. Endoscopists were grouped into quartiles (Q1, Q2, Q3, and Q4), from lowest to highest polyp detection rate, in order to evaluate whether there were any differences in the development of post-colonoscopy colorectal cancer. RESULTS: the lowest polyp detection rate was 20.66% and the highest was 52.16%, with a median of 32.78 and a standard deviation of ± 8.54. A strong and positive association between polyp endoscopy diagnosis and adenoma histopathology result was observed and a linear regression was performed. A significantly higher post-colonoscopy colorectal cancer rate was observed in the group of endoscopists with a lower polyp detection rate (p < 0.02). CONCLUSION: polyp detection rate is a valuable quality indicator of colonoscopy and its calculation is much simpler than that of the adenoma detection rate. In our study, the prevalence of post-colonoscopy colorectal cancer was inversely and significantly related to the endoscopists' polyp detection rate.

A FCGR3A Polymorphism Predicts Anti-drug Antibodies in Chronic Inflammatory Bowel Disease Patients Treated With Anti-TNF.

BACKGROUND: The production of anti-drug antibodies (ADAs) against IgG monoclonal antibodies (mAbs) targeting tumour necrosis factor (TNF) is an important cause of loss of response to anti-TNF mAbs in patients with inflammatory bowel diseases (IBD) such as Crohn's disease (CD) and ulcerative colitis (UC). Since receptors for the Fc portion of IgG (FCGRs) are involved in the degradation of IgG complexes, we hypothesised that a polymorphism in FCGR3A (V158F; rs396991) gene could be involved in anti-TNF ADA generation and treatment resistance. MATERIAL AND METHODS: A cohort of 103 IBD patients (80 CD, 23 UC) were genotyped and serum level of both anti-TNFs (infliximab or adalimumab) and ADA against them were measured. RESULTS: No significant differences were observed between ADA occurrence or V158F genotype and type of disease or the kind of anti-TNF administrated. Interestingly, VV genotype correlated with patients producing ADA (VV: 37.5% vs. FV: 10.6% or FF: 5%; p=0.004) and was an independent predictor of this event after multivariate analysis. Moreover, VV genotype also correlated with those patients receiving anti-TNF dose intensification (p=0.03). CONCLUSION: FCGR3A V158F polymorphism seems to be associated with ADA production against mAbs and it could be taken into account when considering the dose and type of anti-TNF in IBD patients.

Acoustic radiation force impulse imaging for detection of liver fibrosis in overweight and obese children.

Background Acoustic radiation force impulse (ARFI) is a non-invasive alternative to a liver biopsy for the evaluation of liver fibrosis (LF). Purpose To investigate the potential usefulness of acoustic radiation force impulse ARFI for detecting LF in overweight and obese children Material and Methods A cross-sectional study was conducted in 148 schoolchildren. A diagnosis of non-alcoholic fatty liver disease (NAFLD) and LF was based on ultrasound (US) and ARFI shear wave velocity (SWV). Results The laboratory parameters were normal in all the children. NAFLD was observed in 50 children (33.8%). The median SWV was 1.18 ± 0.28 m/s. Differences between ARFI categories and hepatic steatosis grades were observed (χ2 = 43.38, P = 0.0005). No fibrosis or insignificant fibrosis (SWV ≤ 1.60 m/s) was detected in 137 children (92.5%), and significant fibrosis (SWV > 1.60 m/s) in 11 children (7.5%), nine of whom had normal US or mild steatosis. Conclusion The present study is the first to evaluate the utility of the ARFI technique for detecting LF in overweight and obese children. The results of the study suggest that children with normal laboratory parameters such as normal liver ultrasound or mild steatosis may present with significant LF.