Fetal Endoscopic Third Ventriculostomy Is Technically Feasible in Prenatally Induced Hydrocephalus Ovine Model.

BACKGROUND: Congenital obstructive hydrocephalus generates progressive irreversible fetal brain damage by ventricular enlargement and incremental brain tissue compression that leads to maldevelopment and poor clinical outcomes. Intrauterine treatments such as ventriculo-amniotic shunting have been unsuccessfully tried in the eighties. OBJECTIVE: To assess if prenatal endoscopic third ventriculostomy (ETV) is feasible in a large animal model and optimize this technique for ventricular decompression and potential arrest of fetal brain damage in fetal lambs. METHODS: We generated hydrocephalus in 50 fetal lambs by injecting a polymeric agent into the cisterna magna at midgestation (E85). Subsequently, 3 weeks later (E105), fetal ETV was performed using a small rigid fetoscope. The endoscopy entry point was located anterior to the coronal suture, 7 mm from the midline. RESULTS: We obtained clear visualization of the enlarged lateral ventricles by endoscopy in the hydrocephalic fetal lambs. The floor of the third ventricle was bluntly perforated and passed with the scope for a successful ETV. Total success was achieved in 32/50 cases (64%). Causes of failure were blurred vision or third ventricle obliteration by BioGlue in 10/50 (20%) cases, anatomic misdirection of the endoscope in 5 (10%) cases, 2 cases of very narrow foramen of Monro, and 1 case of choroid plexus bleeding. If we exclude the cases artificially blocked by the polymer, we had a successful performance of prenatal-ETV in 80% (32/40) of hydrocephalic fetuses. CONCLUSION: Despite the inherent difficulties arising from ovine brain anatomy, this study shows that innovative fetal ETV is technically feasible in hydrocephalic fetal lambs.

In Vitro and In Vivo Response of Zinc-Containing Mesoporous Bioactive Glasses in a Sheep Animal Model.

Zinc-enriched mesoporous bioactive glasses (MBGs) are bioceramics with potential antibacterial and osteogenic properties. However, few assays have been performed to study these properties in animal models. In this study, MBGs enriched with up to 5% ZnO were synthesized, physicochemically characterized, and evaluated for their osteogenic activity both in vitro and in vivo. The ZnO MBGs showed excellent textural properties despite ZnO incorporation. However, the release of Zn2+ ions inhibited the mineralization process when immersed in simulated body fluid. In vitro assays showed significantly higher values of viability and expression of early markers of cell differentiation and angiogenesis in a ZnO-content-dependent manner. The next step was to study the osteogenic potential in a sheep bone defect model. Despite their excellent textural properties and cellular response in vitro, the ZnO MBGs were not able to integrate into the bone tissue, which can be explained in terms of inhibition of the mineralization process caused by Zn2+ ions. This work highlights the need to develop nanostructured materials for bone regeneration that can mineralize to interact with bone tissue and induce the processes of implant acceptance, cell colonization by osteogenic cells, and regeneration of lost bone tissue.

Effects of peri-implant infection on serum biochemical analysis.

BACKGROUND: Peri-implant disease (PID) has not been directly linked to pathological organ changes. The present study assessed the dynamics of serum biochemical parameters in a model of experimental peri-implantitis in dogs, followed by open flap debridement. METHODS: Seven male beagle dogs comprised the study group. Procedures were performed as follows-extractions of two premolars and one molar on each mandibular quadrant (Day 0); bone healing time (week14); placement of four rough-surface endoosseous implants, two on each mandibular side; implant uncovering (week 28); induction of experimental peri-implantitis by the use of three ligatures (weeks 31, 34, 37) followed by open flap debridement (week 42). Serum biochemical analysis following each procedure was compared to baseline. Biochemical parameters were assigned into four subsets of variables-inflammation, renal function, liver function, and blood glucose. Wilcoxon paired tests were conducted in order to identify statistically significant differences between baseline data and values obtained after each procedure RESULTS: Following experimental peri-implantitis, the dynamics of renal parameters and blood glucose were minimal whereas statistically significant (P < 0.05) increases were noted for inflammatory (total protein and albumin concentrations) and hepatic (ALT, AST) parameters. A statistically significant (P < 0.05) decrease was only noted for total bilirubin. After open flap debridement, inflammatory (total protein and albumin concentrations) and hepatic (AST) parameters returned to baseline. CONCLUSIONS: Within their limits, the present results indicate that: (a) PID affects inflammatory and hepatic serum biochemical parameters, and (b) following open flap debridement most of the values returned to baseline.

Peri-implant disease affects systemic complete blood count values-an experimental in vivo study.

OBJECTIVES: To assess complete blood count (CBC) dynamics following ligature removal and open flap debridement in experimental peri-implantitis in dogs. MATERIALS AND METHODS: Seven male beagle dogs were included in the study. Four rough-surface implants were placed pair-wise in both sides of the mandible 14 weeks after tooth extraction. Second stage surgery was performed after 14 weeks. Experimental peri-implantitis was initiated 3 weeks later by ligature placement around the healing caps thus facilitating plaque accumulation and inducing inflammation and destruction of peri-implant tissues. Ligature removal and open flap debridement were performed 11 weeks later. The CBC values were compared with baseline after each procedure. Wilcoxon paired tests were conducted in order to identify statistically significant differences between baseline data and values obtained after each procedure. RESULTS: Following experimental peri-implantitis, statistically significant (p < 0.05) increases were noted for white blood cells-WBC (9.62 ± 4.34 vs. 6.48 ± 1.34 cells per microliter of blood × 1000), hemoglobin-Hb (15.25 ± 0.94 vs. 13.52 ± 1.46, grams per deciliter), red blood cells-RBC (7.26 ± 0.79 vs. 5.9 ± 0.61 cells per microliter of blood × 1000), mean corpuscular hemoglobin-MCH (23.64 ± 0.96 vs. 23.16 ± 0.83 picograms/cell), platelets-PLT (349.86 ± 51.05 vs. 277.57 ± 66 cells per microliter of blood × 1000), and mean corpuscular hemoglobin concentration-MCHC (35.83 ± 0.27 vs. 31.04 ± 0.48 grams per deciliter). A statistically significant (p < 0.05) decrease in values was noted only for after ligature removal and open flap debridement. Mean corpuscular volume-MCV values were significantly lower (65.99 ± 2.31 vs. 74.65 ± 2.85 femtoliter) following 1st ligature. Values returned to baseline after open flap debridement. CONCLUSIONS: Within its limits, the present data suggest that experimentally induced peri-implantitis affects CBC values. Following surgical treatment, CBC values returned to normal. Clinical relevance This is the first study suggesting possible relationships between peri-implantitis and CBC values. Future studies, confirming such correlation, may provide an insight into the importance of peri-implant maintenance and treatment to minimize supporting tissues disease and reduce systemic effects.

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.

Development and initial assessment of a training program for laparoscopic radical prostatectomy. First module: the urethrovesical anastomosis.

PURPOSE: We present our experience in the design and development of a training program in laparoscopic radical prostatectomy (LRP), and the validation of the first steps of the program by objective measurement of the attendants' skills improvement and subjective evaluation of its contents. MATERIALS AND METHODS: Our training model on LRP has a total duration of 42 hours, divided in two modules of 21 hours each, performed 1 month apart. Data included in the present study were obtained from the first module of our course. It begins with acquisition of basic knowledge in ergonomics and instrument concepts, after which the attendants develop essential laparoscopic dexterities through the performance of hands-on physical simulator tasks. During the second and third day, urologists performed urethrovesical anastomosis also in the physical simulator. Attendants' skills improvement was measured during the first module by registering surgical times and suturing quality of the anastomosis, the latter by means of a leak test. At the end of the training program, a subjective evaluation questionnaire on the different didactic and organizational aspects was handed out to the attendants. RESULTS: By comparing first and last anastomosis, we observed a significant decrease in surgical times (minutes) (T1 40.1±4.6 vs T6 24.01±3.34; P≤0.005) and an increase in intraluminal leak pressure (mm Hg) (T1 8.27±7.33 vs T6 21.09±6.72; P≤0.005). We obtained a highly positive score on all questions concerning the different topics and techniques included in the training program (≥9 points over 10). Regarding the attendants' self-assessment of acquired abilities, 78.3% considered themselves capacitated to perform the trained procedures on patients. CONCLUSIONS: Training obtained during the first module of our training model significantly decreased performance times for ex vivo urethrovesical anastomosis, simultaneously increasing its quality. In addition, validation of the training model was also demonstrated by the highly scored evaluation resulting from the attendants' assessment.