¿Permiten la citología, el genotipado y la anoscopia de alta resolución establecer un protocolo para la detección precoz del carcinoma epidermoide de canal anal en población de riesgo? / Do cytology, genotyping, and high resolution anoscopy allow to establish a protocol for early detection of squamous cell carcinoma of the anal canal in risk population?

Introducción: El cáncer anal ha experimentado un aumento de incidencia en los últimos años. Está mediado por el VPH y precedido de cambios precancerosos planteando la posibilidad de dirigir los esfuerzos preventivos hacia los grupos de alto riesgo. Sigue siendo controvertida la indicación de cribado y los métodos de detección ideales. Objetivo: Validar las pruebas de cribado implementadas en la actualidad comparadas con la biopsia como "gold standard". Material y Métodos: Estudio transversal con recogida de datos prospectiva, en una cohorte de hombres VIH+ que tienen sexo con hombres, pertenecientes al Hospital Gregorio Marañón e Infanta Leonor en un periodo de 2 años. Resultados: Se seleccionaron 179 pacientes con 286 visitas a la consulta de screening en las que se llevaron a cabo 3 pruebas de cribado en paralelo (citología anal, genotipado del VPH y anoscopia de alta resolución (AAR) con toma de biopsia dirigida sobre zona sospechosa o aleatoria). La sensibilidad y especificidad para la detección de displasia de alto grado y cáncer y su grado de concordancia con la biopsia fue la siguiente: citología 3,23%/94,43% (k: 0,03), genotipado de VPH de alto riesgo 90,32%/27,45% (k: 0,05), AAR 32,26%/87,45 (k: 0, 17) siendo el rendimiento diagnóstico de las tres pruebas muy bajo. Conclusión: La citología presenta un rendimiento diagnóstico muy bajo comparado con el genotipado que representa el mayor. A la luz de nuestros resultados, los protocolos clínicos tal y como vienen desarrollándose en la actualidad deberían de ser abandonados.

Introduction: The incidence of anal cancer has increased in recent years. It is mediated by HPV and preceded by precancerous changes, raising the possibility of directing preventive efforts towards high-risk groups. The indication of screening remains controversial and which methods would be the ideal ones. Objective: To validate the screening tests established actually, comparing it with the biopsy considered as the "gold standard". Materials and Methods: A cross-sectional study was performed, with prospective data collection in a cohort of VIH+ patients, who have male homosexual anal relations, belonging to Gregorio Marañón and Infanta Leonor Hospitals in a period of 2 years. Results: A total of 179 patients were selected with 286 visits to the screening Outpatient Clinic in which 3 parallel screening tests were performed (anal cytology, HPV genotyping and high resolution anoscopy (AAR) with a biopsy directed on a suspicious or random area). The sensitivity and specificity for the detection of high-grade dysplasia and cancer and their degree of agreement with the biopsy was as follows: cytology 3.23%/94.43% (k: 0.03), high HPV genotyping. risk 90.32%/27.45% (k: 0.05), AAR 32.26%/87.45 (k: 0, 17), the diagnostic accuracy of the three tests being very low. Conclusion: Cytology shows a very low diagnostic accuracy compared to the genotype that represents the highest one. In light of our results, clinical protocols as they are currently being developed should be abandoned.

Hernia diafragmática intrapericárdica postraumática de diagnóstico tardío / Delayed diagnosis of a traumatic intrapericardial diaphragmatic hernia

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La banda gástrica ajustable como tratamiento de la obesidad mórbida: ¿son reproducibles los resultados mundiales en España? Análisis de 132 pacientes intervenidos en los últimos 10 años / Adjustable gastric band as surgical treatment for morbid obesity. Are worldwide results reproducibles in Spain?

Introducción La banda gástrica ajustable es una técnica afianzada en el mundo en el tratamiento de la obesidad mórbida. En España, las cifras de pacientes intervenidos de banda gástrica distan mucho de las cifras mundiales, habiéndose alegado un alto número de reintervenciones. Material y métodos En el año 2001 iniciamos, un programa de tratamiento quirúrgico de la obesidad mediante la implantación de banda gástrica ajustable. Paralelamente, desarrollamos un sistema exhaustivo de seguimiento para evitar complicaciones y mejorar los resultados. Resultados Desde el año 2001 hasta el 2011 hemos intervenido un total de 132 pacientes, 102 mujeres y 30 hombres, con una edad media de 39 años y un índice de masa corporal medio de 43. El seguimiento fue superior a 5 años en 61 pacientes; en el resto, el seguimiento medio fue de 44, 4 meses. La mortalidad y complicaciones graves fue 0. Ocho pacientes requirieron cirugía de revisión (6,06%), 3 por complicaciones relacionadas con el reservorio, 4 por deslizamiento y una por erosión. Tres deslizamientos se convirtieron a otra técnica y otro se resolvió con colocación de una nueva banda de tipo Lap Band. El porcentaje de sobrepeso perdido medio se mantuvo en los pacientes con un seguimiento superior a los 5 años en 54, 8%.ConclusionesLos resultados de nuestra serie son superponibles a los publicados en la literatura mundial en nuestro medio y demuestran que, reproduciendo el seguimiento realizado, la banda gástrica es un método eficaz y seguro para el control del peso en los pacientes con obesidad mórbida también en España(AU)

Introduction Adjustable gastric banding is a surgical technique used all over the world for the treatment of morbid obesity. In Spain, the number of patients treated with adjustable gastric banding is far lower than the average worldwide average. A number of reasons have been put forward to explain this difference. Material and methods A program of bariatric surgery by means of implantation of an adjustable gastric banding was started in 2001, together with a dedicated follow-up protocol in order to prevent complications and improve results. Results A total of 132 patients were operated on between 2001 and 2011. The mean age of the 102 female and 30 male patients was 39 years, and the mean body mass index was 43. Follow-up was longer than 5 years in 61 patients, while the mean follow-up in the rest was 44.4 months. There was no mortality or severe morbidity. Eight patients (6.06%) underwent reoperation, 3 of them for complications related to the reservoir, 4 for slipping of the band, and one for erosion. One slipped band was removed, and a new one (of the Lap Band type) was inserted. Three slipping bands were converted to other techniques. The percentage excessive body weight loss was maintained in 54.8% of the patients followed-up for longer than 5 years. Conclusions The results of our series are comparable to those reported in the literature and show that, provided that a close follow-up, like that performed by most groups, is implemented, adjustable gastric banding can also be a safe and effective bariatric surgery technique in our country (AU)

[Adjustable gastric band as surgical treatment for morbid obesity. Are worldwide results reproducibles in Spain?]. / La banda gástrica ajustable como tratamiento de la obesidad mórbida: ¿son reproducibles los resultados mundiales en España? Análisis de 132 pacientes intervenidos en los últimos 10 años.

INTRODUCTION: Adjustable gastric banding is a surgical technique used all over the world for the treatment of morbid obesity. In Spain, the number of patients treated with adjustable gastric banding is far lower than the average worldwide average. A number of reasons have been put forward to explain this difference. MATERIAL AND METHODS: A program of bariatric surgery by means of implantation of an adjustable gastric banding was started in 2001, together with a dedicated follow-up protocol in order to prevent complications and improve results. RESULTS: A total of 132 patients were operated on between 2001 and 2011. The mean age of the 102 female and 30 male patients was 39 years, and the mean body mass index was 43. Follow-up was longer than 5 years in 61 patients, while the mean follow-up in the rest was 44.4 months. There was no mortality or severe morbidity. Eight patients (6.06%) underwent reoperation, 3 of them for complications related to the reservoir, 4 for slipping of the band, and one for erosion. One slipped band was removed, and a new one (of the Lap Band type) was inserted. Three slipping bands were converted to other techniques. The percentage excessive body weight loss was maintained in 54.8% of the patients followed-up for longer than 5 years. CONCLUSIONS: The results of our series are comparable to those reported in the literature and show that, provided that a close follow-up, like that performed by most groups, is implemented, adjustable gastric banding can also be a safe and effective bariatric surgery technique in our country.

Utilización de adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo: resultados preliminares del ensayo clínico fase iv multicéntrico, prospectivo, aleatorizado y controlado simple ciego: Protissucol001 / Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001

Introducción: Con el objetivo de demostrar la eficacia de los adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas, en enero de 2007 iniciamos un estudio multicéntrico, prospectivo, aleatorizado, controlado, simple ciego, sobre la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo mediante la utilización de adhesivos biológicos a base de fibrina. Material y métodos En enero de 2007 iniciamos un ensayo clínico multicéntrico en el que participan los hospitales Gregorio Marañón, Universitario de San Carlos y Hospital del Sureste, de Madrid sobre la prevención de defectos de cicatrización anastomótica mediante la aplicación de adhesivos biológicos a base de fibrina en la linea de sutura. Los pacientes reclutados se aleatorizan asignando al paciente en función de esta aleatorización a uno de los 2 grupos: grupo de estudio en el que se aplica adhesivo en la línea de sutura y grupo control en el que no se aplica. La variable principal del estudio es la presencia o ausencia de fugas. El ensayo ha sido aprobado por los correspondientes Comités de Ética e Investigación Clínica, por la Agencia Española del Medicamento y registrado en www.clinicaltrials.gov (NCT01306851). Ninguno de los autores manifiesta tener conflicto de interés con la empresa Baxter, que comercializa el producto en España. Resultados Desde enero de 2007 hasta noviembre de 2010, se ha reclutado a 104 pacientes que han sido asignados tras aleatorización, 52 al grupo de estudio y 52 al grupo control. Se han registrado 22 fugas anastomóticas de las cuales 7 en el grupo de estudio (13, 4%) y 15 en el grupo control (28, 8%) con un valor de la P de 0,046. El índice de riesgo de fugas fue de 0,384, es decir, se produce una reducción del 61% en las fugas de los pacientes a los que se aplica adhesivo biológico a (..) (AU)

Introduction: A multicentre, prospective, randomised, controlled, and simple blind clinicaltrial was started in January 2007, with the aim of demonstrating the eficacy of fibrin-based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract. Material and methods: A study on the prevention of anastomotic healing defects by applying biological adhesives along the suture line began in January 2007, and included the hospitals, Gregorio Marañón, Universitario de San Carlos, and Hospital del Sureste, in Madrid. The enrolled patients were randomised to one of 2 groups: the study group in which the adhesive was applied to the suture line, and a control group in which it was not applied. The primary outcome of the study was the presence or absence of leaks. The trial was approved by the corresponding Clinical Research Ethics Committees and the Spanish Medicines Agency(AEMPS) and registered www.clinicaltrials.gov (NCT01306851). The authors declared not to have any (..) (AU)

[Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001]. / Utilización de adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo: resultados preliminares del ensayo clínico fase iv multicéntrico, prospectivo, aleatorizado y controlado simple ciego: Protissucol001.

INTRODUCTION: A multicentre, prospective, randomised, controlled, and simple blind clinical trial was started in January 2007, with the aim of demonstrating the efficacy of fibrin-based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract. MATERIAL AND METHODS: A study on the prevention of anastomotic healing defects by applying biological adhesives along the suture line began in January 2007, and included the hospitals, Gregorio Marañón, Universitario de San Carlos, and Hospital del Sureste, in Madrid. The enrolled patients were randomised to one of 2 groups: the study group in which the adhesive was applied to the suture line, and a control group in which it was not applied. The primary outcome of the study was the presence or absence of leaks. The trial was approved by the corresponding Clinical Research Ethics Committees and the Spanish Medicines Agency (AEMPS) and registered www.clinicaltrials.gov (NCT01306851). The authors declared not to have any conflict of interests with the company, Baxter, which markets the product in Spain. RESULTS: A total of 104 patients were recruited between January 2007 and November 2010, of whom 52 were randomised to the study group, and 52 to the control group. A total of 22 anastomotic leaks were recorded, of which 7 (13.4%) were in the study group, and 15 (28.8%) in the control group (P=.046). The leak risk index was 0.384, which means that there was a 61% reduction in leaks in the patients who had the fibrin-based biological adhesive applied. There were 3 (5.7%) further surgeries in the study group, compared to 12 (23%) in the control group (P=.12). On analysing the mortality, it was observed that 3 patients in the study group and 4 patients in the control group died (5.7% vs. 7.7%, P=.5). No other significant differences were found as regards the type of suture, surgical time, or pre-surgical history, except that the use of drainages appeared to be a protective factor of anastomotic leak (P=.041), although the use or not of a drainage was not a controlled factor, but at the discretion of each surgeon. CONCLUSIONS: Our study demonstrates, significantly, that in the 104 patients in the study that fibrin based biological adhesives are capable of preventing anastomotic leaks in the high risk digestive tract, reducing the risk of leaks by 61% and a further surgeries. This is the first clinical trial that shows these significant results. If our results are maintained at the end of the study, it will show that anastomotic leaks can be prevented with the application of these adhesives, thus their application may be recommended in all the anastomosis of the high risk digestive tract.

[Severe pelvic fractures, associated injuries and hemodynamic instability: incidence, management and outcome in our center]. / Fracturas de pelvis graves, lesiones asociadas e inestabilidad hemodinámica: incidencia, manejo y pronóstico en nuestro medio.

INTRODUCTION: The aim of this study was to review the incidence, treatment and outcome of severe pelvic fractures, as well as associated injuries, in our center. PATIENTS AND METHOD: We performed a retrospective study of patients included in our trauma registry between June 1993 and January 2005. Pelvic fractures were classified according to the system proposed by Tile. Clinical and demographic data such as age, gender, mechanism of injury, transfer time, hemodynamic status, and trauma scores were compared and analyzed statistically. Shock was defined as a systolic blood pressure of < or = 90 mmHg during the primary assessment. Mortality and associated risk factors were analyzed, with emphasis on patients in shock on admission. RESULTS: Of 1274 patients with severe trauma admitted during the study period, 192 (15%) had pelvic fracture. Only 6.7% were isolated fractures and 6% were open fractures. Twenty percent of the patients were in shock on admission. The mean Injury Severity Score of the series was 28.5 +/- 14 and that of patients in shock was 38 +/- 16. The most frequently associated injuries were thoracic (70%), abdominal (55%), long bone fractures (52%), and head injuries (40%). Twenty-three percent of the patients had retroperitoneal hematoma. Arteriograms were performed in 16 patients, with four embolizations. Eight patients underwent external orthopedic fixation, and none posterior orthopedic fixation. Five patients underwent pelvic packing and two patients underwent ligation of hypogastric arteries. Overall mortality was 30% and mortality in patients in shock was 61%. Predictors of mortality were shock on admission, a Glasgow Coma Scale score of < or = 8, ISS > 25 and age > 55 years. CONCLUSIONS: Patients in shock with pelvic fractures have a poor prognosis in our center, frequently related to the severity of associated injuries, the relative rarity of these fractures, and the lack of a clearly defined management protocol. The main cause of death was massive hemorrhage.

Fracturas de pelvis graves, lesiones asociadas e inestabilidad hemodinámica: incidencia, manejo y pronóstico en nuestro medio / Severe pelvic fractures, associated injuries and hemodynamic instability: incidence, management and outcome in our center

Introducción. El objetivo de esta revisión ha sido conocer la incidencia, lesiones asociadas, tratamiento y resultados obtenidos en el manejo de los pacientes con fracturas graves de pelvis en nuestro centro. Pacientes y método. Estudio retrospectivo de los pacientes incluidos en nuestro registro de traumatizados graves entre junio de 1993 y enero de 2005. La clasificación de las fracturas pelvianas se ha realizado con los criterios de Tile. Se comparan y analizan estadísticamente aspectos demográficos y clínicos, incluidos la edad, el sexo, el mecanismo lesivo, tiempo de traslado, la situación hemodinámica al ingreso y las escalas de gravedad. Se ha definido el estado de shock como una presión arterial sistólica ≤ 90 mmHg durante la revisión primaria. Se analizan la mortalidad y los factores de riesgo asociados, con especial énfasis en el grupo de pacientes en shock. Resultados. De los 1.274 politraumatizados graves atendidos en el período de estudio, 192 (15%) presentaban fractura pelviana. Muy pocas fracturas se han presentado como lesiones aisladas (6,7%), y el porcentaje de fracturas abiertas ha sido del 6%. El 20% de los pacientes presentaba shock al ingreso. El Injury Severity Score (ISS) medio de la serie fue de 28,5 ± 14, y el de los pacientes en shock fue de 38 ± 16. Las lesiones asociadas más frecuentes fueron las torácicas (70%), seguidas por las abdominales (55%), fracturas de huesos largos (52%) y craneoencefálicas (40%). El 23% de los pacientes presentaba hematoma retroperitoneal. Se realizaron 16 arteriografías y 4 embolizaciones pelvianas. Se colocaron 8 fijadores externos anteriores y ninguno posterior. Se realizaron 5 taponamientos pelvianos y 2 ligaduras de arterias hipogástricas. La mortalidad general fue del 30%, y del 61% en los pacientes en shock al ingreso. El shock a la llegada, una escala de coma de Glasgow ≤ 8, un ISS > 25 y la edad > 55 años se correlacionaron con la mortalidad. Conclusiones. El pronóstico de los pacientes en shock y con fracturas de pelvis graves en nuestro medio es sombrío y, con frecuencia, está condicionado por la gravedad de las lesiones asociadas, la relativa escasa incidencia de estas fracturas y la heterogeneidad de criterios de manejo de los equipos de guardia. La hemorragia masiva incontrolada ha sido la causa principal de muerte (AU)

Introduction. The aim of this study was to review the incidence, treatment and outcome of severe pelvic fractures, as well as associated injuries, in our center. Patients and method. We performed a retrospective study of patients included in our trauma registry between June 1993 and January 2005. Pelvic fractures were classified according to the system proposed by Tile. Clinical and demographic data such as age, gender, mechanism of injury, transfer time, hemodynamic status, and trauma scores were compared and analyzed statistically. Shock was defined as a systolic blood pressure of ≤ 90 mmHg during the primary assessment. Mortality and associated risk factors were analyzed, with emphasis on patients in shock on admission. Results. Of 1274 patients with severe trauma admitted during the study period, 192 (15%) had pelvic fracture. Only 6.7% were isolated fractures and 6% were open fractures. Twenty percent of the patients were in shock on admission. The mean Injury Severity Score of the series was 28.5 ± 14 and that of patients in shock was 38 ± 16. The most frequently associated injuries were thoracic (70%), abdominal (55%), long bone fractures (52%), and head injuries (40%). Twenty-three percent of the patients had retroperitoneal hematoma. Arteriograms were performed in 16 patients, with four embolizations. Eight patients underwent external orthopedic fixation, and none posterior orthopedic fixation. Five patients underwent pelvic packing and two patients underwent ligation of hypogastric arteries. Overall mortality was 30% and mortality in patients in shock was 61%. Predictors of mortality were shock on admission, a Glasgow Coma Scale score of ≤ 8, ISS > 25 and age > 55 years. Conclusions. Patients in shock with pelvic fractures have a poor prognosis in our center, frequently related to the severity of associated injuries, the relative rarity of these fractures, and the lack of a clearly defined management protocol. The main cause of death was massive hemorrhage (AU)