Novel Osteoinductive and Osteogenic Scaffolds of Monetite, Amorphous Calcium Phosphate, Hydroxyapatite, and Silica Gel: Influence of the Hydroxyapatite/Monetite Ratio on Their In Vivo Behavior and on Their Physical and Chemical Properties.

In this work, a new family of multiphasic materials composed of the same amount of silica gel and variable amount of three calcium phosphates with very different solubilities, monetite > amorphous calcium phosphate > hydroxyapatite (HAp), was studied. Silicon was added to calcium phosphate to increase bioactivity and osteinductivity. The influence of the HAp/monetite ratio on the material resorption and bone regeneration was investigated in critical bone defects in sheep and was related to their chemical and physical properties. It was concluded that a minimum rate of HAp/monetite is necessary to achieve an appropriate compromise between material resorption and bone regeneration. Above this minimum rate, bone regeneration and material resorbtion did not change significantly. Physical properties such as particle size, specific surface area, porosity, and granulate cohesion played a more critical role on material resorption than the solubility of their components. A huge difference between in vitro solubility and in vivo resorption was observed. It was related to the fastest cellular-mediated resorption of monetite compared to the other components. Computerized axial tomography, histology, histomorphometric, and multiple fluorochrome labeling studies showed a very advanced bone regeneration of the defects when materials with the highest HAp/monetite rate were implanted. It was also demonstrated that all materials induce bone formation and vascularization.

Evaluación de competencias en Urología. Esscolap® basic, como aproximación a la mejora de las capacidades de los urólogos / Evaluation of competencies in urology. Esscolap® basic, as aproximation to urologists skills improvement

Introducción: La Urología necesita de modelos de evaluación de capacidades, a pesar de que existe una variada oferta de herramientas que no están integradas en los programas de formación. Contexto: No existe un criterio universal para medir el nivel de competencia. Los programas de formación deben proporcionar conocimientos y destrezas, y deben considerar las habilidades cognitivas, la formación basada sobre simulación y modelo animal. La validez es un concepto complejo que hace referencia a la capacidad del instrumento de evaluación, por lo que es necesario establecer varios tipos de validación para asegurar la capacidad de un método, reforzarse con distintos test de fiabilidad y cálculo de consistencia interna entre evaluadores. Objetivo: A partir de un dossier estructurado de competencias quirúrgicas, clasificadas por grupos, se planteó el sistema ESSCOLAP® Basic con 5 ejercicios sobre simulador, para la evaluación de las competencias básicas en Laparoscopia. Una vez validado, en el CCMIJU, se planteó ampliar el alcance e implementación del mismo en otras localizaciones. Resultados: Nuestro sistema no ha demostrado aún su validez en el ámbito clínico real, porque no presenta una validez predictiva con datos clínicos de resultados en salud. Existe, además, un cierto rango de subjetividad, por lo que se requiere establecer criterios claros y definidos para cualquier situación. El número de evaluadores y de los ejercicios a evaluar, va a influir en los test de fiabilidad que miden el grado de acuerdo entre evaluadores, de modo que sólo obteniendo un elevado número de casos evaluados, podremos acercarnos a una mayor fiabilidad de nuestro sistema. Por último, asumimos que la incorporación de este tipo de herramientas implica un coste añadido a cargo de las instituciones públicas y privadas responsables, que sólo se considerará rentable cuando se demuestre su trazabilidad real y positiva en resultados sanitarios. Conclusiones: ESSCOLAP® Basic, con capacidad de implementación rápida y sencilla, ha sido validado y contrastado para la evaluación de las habilidades técnicas básicas en laparoscopia (AU)

Introduction: Urology needs models of competencies assessment, although there is a wide range of tools not yet integrated into the official training programs. Context: At present, there is no universal framework for measuring surgeons ́ level of competence. Urology training programs should provide and consider knowledge, pyschomotor/cognitive skills, and simulator, cadaver or animal models-based training. Validity is a complex concept that refers to the capacity of the evaluation tool, so it is necessary to demonstrate several types of validation to assure the capacity of a method, reinforced with different reliability tests and calculation of internal consistency between evaluators. Objective: Based on a structured dossier of surgical skills, classified by groups, the ESSCOLAP® Basic system was proposed with 5 simulator tasks to evaluate basic laparoscopic skills. Once validated in the JUMISC (Spain), the tool was proposed to extend its scope and implementation in other locations. Results: Our system has not yet demonstrated a full validity in the real clinical setting because a predictive validity needs to be demonstrated on the basis of clinical data. It also suffers from a certain range of subjectivity, thus implying clear and defined criteria for any situation. Factors like the number of evaluators and tasks to assess will influence the reliability tests that measure the degree of agreement between evaluators, so that a higher number of evaluated cases would imply a greater reliability of our system. Finally, we assume that the incorporation of this type of tools implies an added cost, charged to the public and private responsible institutions, which will only be considered cost-effective when it is demonstrated its real and positive traceability in health outcomes. Conclusions: ESSCOLAP® Basic, of quick and simple implementation capacity, has been validated and calibrated for the evaluation of basic technical skills in laparoscopy (AU)

[Evaluation of competencies in urology. Esscolap® basic, as aproximation to urologists skills improvement.] / Evaluación de competencias en Urología. Esscolap® basic, como aproximación a la mejora de las capacidades de los urólogos.

Urology needs models of competencies assessment, although there is a wide range of tools not yet integrated into the official training programs. CONTEXT: At present, there is no universal framework for measuring surgeons' level of competence. Urology training programs should provide and consider knowledge, pyschomotor/cognitive skills, and simulator, cadaver or animal models-based training. Validity is a complex concept that refers to the capacity of the evaluation tool, so it is necessary to demonstrate several types of validation to assure the capacity of a method, reinforced with different reliability tests and calculation of internal consistency between evaluators. OBJECTIVE: Based on a structured dossier of surgical skills, classified by groups, the ESSCOLAP® Basic system was proposed with 5 simulator tasks to evaluate basic laparoscopic skills. Once validated in the JUMISC (Spain), the tool was proposed to extend its scope and implementation in other locations. RESULTS: Our system has not yet demonstrated a full validity in the real clinical setting because a predictive validity needs to be demonstrated on the basis of clinical data. It also suffers from a certain range of subjectivity, thus implying clear and defined criteria for any situation. Factors like the number of evaluators and tasks to assess will influence the reliability tests that measure the degree of agreement between evaluators, so that a higher number of evaluated cases would imply a greater reliability of our system. Finally, we assume that the incorporation of this type of tools implies an added cost, charged to the public and private responsible institutions, which will only be considered cost-effective when it is demonstrated its real and positive traceability in health outcomes. CONCLUSIONS: ESSCOLAP® Basic, of quick and simple implementation capacity, has been validated and calibrated for the evaluation of basic technical skills in laparoscopy.

Laparoscopic Cholecystoduodenostomy in Dogs: Canine Cadaver Feasibility Study.

OBJECTIVE: To evaluate the feasibility of laparoscopic cholecystoduodenostomy in canine cadavers using barbed self-locking sutures. STUDY DESIGN: In vivo experimental study. ANIMALS: Fresh male Beagle cadavers (n=5). METHODS: Surgery was performed by a single veterinary surgeon. Dogs were placed in dorsal recumbency and 15° reverse Trendelenburg position. The surgical procedure was performed with four 5 mm entry ports and a 5 mm 30° telescope. The cholecystoduodenostomy technique included dissection, incision of the gallbladder, and lavage, followed by gallbladder transposition over the duodenum, incision of the duodenum, and anastomosis. The latter was performed with a 4-0 barbed self-locking suture (V-Loc® 180). Subsequently, a leak test was performed by submerging the anastomosis in saline and insufflating air into the duodenum through a catheter. Total operative time and completion times for each procedural step were recorded. RESULTS: The median total operative time was 151 minutes (range, 129-159). One conversion to open surgery occurred because of vascular hemorrhage. The 3 longest intraoperative steps were posterior wall anastomosis, gallbladder dissection, and anterior wall anastomosis. Intraoperative anastomotic leakage sites were identified in 3 of 5 dogs. Leaks were managed by placement of a single reinforcing conventional intracorporeal suture, which was adequate to obtain a watertight anastomosis. CONCLUSION: This technique cannot be recommended in clinical practice until further studies are performed and the technique is further refined.

Validación preliminar del simulador físico Simulap ® y de su sistema de evaluación para cirugía laparoscópica / Preliminary validation of the Simulap ® physical simulator and its assessment system for laparoscopic surgery

Introducción Nuestro objetivo es evaluar la validez aparente y de contenidos del simulador físico Simulap® y la validez constructiva de su sistema de evaluación. Material y métodos Cinco cirujanos noveles (G1) y 5 cirujanos expertos (G2) realizaron siete ejercicios básicos y uno de sutura en Simulap®, los cuales fueron evaluados en base a los errores y al tiempo. Las validaciones aparente y de contenidos fueron realizadas por los cirujanos noveles y los expertos, respectivamente. Ambas consistieron en un cuestionario sobre Simulap® y sus ejercicios con una escala del 0 al 5. La validez constructiva del sistema de evaluación se determinó comparando las puntuaciones de ambos grupos. Resultados La valoración por parte de los cirujanos del simulador Simulap® y su programa de entrenamiento fue positiva, obteniendo una puntuación media de 4±1,1 para el G1 y de 4,9±0,6 para el G2. El G2 consideró muy útil el entrenamiento con Simulap® para la formación de residentes y cirujanos, obteniendo una puntuación máxima de 5. El G2 superó al G1 en todas las puntuaciones de los ejercicios, observándose diferencias estadísticamente significativas en los ejercicios de coordinación ojo-mano (G1: 52,2±6,7 frente a G2: 39,6±6,5; p=0,027), disección (G1: 301,8±100,2 frente a G2: 150,8±66,7; p=0,028) y sutura (G1: 258,5±87,0 frente a G2: 108,4±20,2; p=0,009).Conclusiones El sistema de evaluación para Simulap® es capaz de distinguir diferentes grados de experiencia en cirugía laparoscópica. Además este simulador mostró una gran aceptación por parte de los cirujanos para el aprendizaje de habilidades básicas (AU)

Introduction Our aim is to assess the face and content validities of the physical simulator Simulap®, as well as the construct validity of its assessment method. Material and methods Five novice surgeons (G1) and five experts (G2) performed seven basic tasks and one suturing exercise on Simulap®, which were assessed through an exam based on mistakes and performance time. Face and content validations were carried out by novice surgeons and expert surgeons, respectively. Both validations consisted of a questionnaire graded on a five-point scale about the Simulap® and its tasks. Construct validity of the assessment system was determined by comparing the scores of both groups. Results Surgeons rated the Simulap® simulator and its training program positively, obtaining an average score of 4±1.1 for G1 and of 4.9±0.6 for G2. G2 considered training on Simulap® very useful for the training of residents and surgeons, obtaining a maximum score of 5. G2 outperformed G1 in all task scores, with statistically significant differences in the eye-hand coordination (G1: 52.2±6.7 vs. G2: 39.6±6.5; P=.027), dissection (G1: 301.8±100.2 vs. G2: 150.8±66.7; P=.028) and suturing exercises (G1: 258.5±87.0 vs. G2: 108.4±20.2; P=.009).Conclusions The assessment method for Simulap® is able to distinguish different levels of experience in laparoscopic surgery. Furthermore, this simulator showed a great acceptance by surgeons for the learning of basic skills (AU)

[Preliminary validation of the Simulap(®) physical simulator and its assessment system for laparoscopic surgery]. / Validación preliminar del simulador físico Simulap(®) y de su sistema de evaluación para cirugía laparoscópica.

INTRODUCTION: Our aim is to assess the face and content validities of the physical simulator Simulap(®), as well as the construct validity of its assessment method. MATERIAL AND METHODS: Five novice surgeons (G1) and five experts (G2) performed seven basic tasks and one suturing exercise on Simulap(®), which were assessed through an exam based on mistakes and performance time. Face and content validations were carried out by novice surgeons and expert surgeons, respectively. Both validations consisted of a questionnaire graded on a five-point scale about the Simulap(®) and its tasks. Construct validity of the assessment system was determined by comparing the scores of both groups. RESULTS: Surgeons rated the Simulap(®) simulator and its training program positively, obtaining an average score of 4±1.1 for G1 and of 4.9±0.6 for G2. G2 considered training on Simulap(®) very useful for the training of residents and surgeons, obtaining a maximum score of 5. G2 outperformed G1 in all task scores, with statistically significant differences in the eye-hand coordination (G1: 52.2±6.7 vs. G2: 39.6±6.5; P=.027), dissection (G1: 301.8±100.2 vs. G2: 150.8±66.7; P=.028) and suturing exercises (G1: 258.5±87.0 vs. G2: 108.4±20.2; P=.009). CONCLUSIONS: The assessment method for Simulap(®) is able to distinguish different levels of experience in laparoscopic surgery. Furthermore, this simulator showed a great acceptance by surgeons for the learning of basic skills.

Construct and face validity of SINERGIA laparoscopic virtual reality simulator.

PURPOSE: Laparoscopic techniques have nowadays become a gold standard in many surgical procedures, but they imply a more difficult learning skills process. Simulators have a fundamental role in the formative stage of new surgeons. This paper presents the construct and face validity of SINERGIA laparoscopic virtual reality simulator in order to decide whether it can be considered as an assessment tool. METHODS: Twenty people participated in this study, 14 were novices and 6 were experts. Five tasks of SINERGIA were included in the study: coordination, navigation, navigation and touch, precise grasping and coordinate traction. For each one of these tasks, a certain number of metrics are automatically recorded. All subjects accomplished each task only once and filled in two questionnaires. A statistical analysis was made and results from both groups were compared with the Mann-Whitney U-test, considering significant differences when P < or = 0.05. Internal consistency of the system has been analyzed with the Cronbach's alpha test. RESULTS: Novices and experts positively rated SINERGIA characteristics. At least one of the evaluated metrics of each exercise presented significant differences between both groups. Nevertheless, all metrics under study gave a better punctuation to the executions accomplished by experts (lower time, higher efficiency, fewer errors. . .) than to those made by novices. CONCLUSION: SINERGIA laparoscopic virtual reality simulator is able to discriminate subjects according to their level of experience in laparoscopic surgery; therefore, it can be used within a training program as an assessment tool.