Estudio de cohortes comparando los resultados obtenidos tras la estadificación y el tratamiento quirúrgico por laparotomía frente al realizado por laparoscopia en el cáncer primario de endometrio estadio I clínico

Consultable des del TDXTítol obtingut de la portada digitalitzadaEl cáncer de endometrio es actualmente la neoplasia más frecuente del tracto genital inferior en los países desarrollados. La estadificación es quirúrgico-patológica y se basa en el estudio de la pieza operatoria. El tratamiento estándar se realiza mediante laparotomía, si bien hay estudios que sugieren puede ser llevado a cabo mediante abordaje laparoscópico-vaginal, con igual radicalidad oncológica y sin mayor número de complicaciones. El propósito de este estudio fue describir la factibilidad y los resultados del abordaje quirúrgico laparoscópico en el tratamiento del cáncer de endometrio estadio I clínico, y compararlos con los obtenidos mediante laparotomía. El objetivo principal fue comparar los resultados en cuanto a supervivencia global, periodo libre de enfermedad y complicaciones. Otros objetivos fueron comparar los datos quirúrgicos, los ganglios retroperitoneales obtenidos y la estancia hospitalaria. La estadificación quirúrgica mediante ambos procedimientos incluyó la realización de citologías peritoneales, histerectomía extrafascial con salpingooforectomía bilateral, linfadenectomía pélvica bilateral ± paraaórtica y omentectomía y biopsias aleatorias en tipos histológicos de alto riesgo. La mayoría de datos se recogieron de forma prospectiva. Se incluyeron en el estudio todas las pacientes diagnosticadas de un cáncer primario de endometrio estadio I en el Hospital Materno-infantil Vall d'Hebron, en las cuales el primer tratamiento pretendió ser la cirugía. El análisis estadístico se realizó mediante el paquete SPSS 11.0. Se utilizaron pruebas de normalidad, pruebas no paramétricas, test de Kaplan y Meier para las estimaciones de supervivencia global y tiempo libre de enfermedad, log-rank test para la comparación univariante de las curvas de supervivencia y modelo de los riesgos proporcionales de Cox para el análisis multivariable. Entre enero/1995 y junio/2001 se incluyeron 371 pacientes con cáncer endometrial estadio I clínico. La estadificación se realizó mediante abordaje laparoscópico-vaginal en 55 pacientes (14,8%) y mediante laparotomía en 315 (84,9%). La edad media fue de 64,3 años y el índice de masa corporal medio de 30 (r, 18-57). Se realizó la cirugía de estadificación óptima en 367 pacientes (98,9%), sin diferencias significativas al comparar las dos vías de abordaje. La linfadenectomía (LND) pélvica se realizó en el 91,1% de las pacientes y la LND aórtica en el 50%. Hubo afectación ganglionar en 41 casos (11,1%) y 32 recurrencias a lo largo del seguimiento (8,6%). El tipo histológico más frecuente fue el endometrioide (74%), seguido del grupo de alto riesgo (seroso-papilar, célula clara y adenoescamoso) con un 16%. El 27,5% de los cánceres fueron mal diferenciados (G3). La distribución por estadios FIGO fue: estadio I (58%), II (24%), III (16%) y IV (2%). Con un seguimiento medio de 40,7 meses, la supervivencia global para el total de las pacientes fue del 92,2% (supervivencia media de 93 meses), siendo del 90,8% para las pacientes del grupo laparotómico y del 100% para las del laparoscópico. La comparación de las curvas de supervivencia entre las dos vías mostró un resultado estadísticamente no significativo (p=0,06). El tiempo libre de enfermedad para el total de pacientes fue del 91,4% (tiempo medio de 93,2 meses), siendo del 90,2% para el abordaje laparotómico y del 98,2% para el laparoscópico. Las curvas de tiempo libre de enfermedad tampoco difirieron (p=0,09). Diferenciando entre ambas vías de abordaje, se hallaron diferencias estadísticamente significativas (p<0,001) en cuanto a datos operatorios: el sangrado intraoperatorio medio, el número de transfusiones y la estancia hospitalaria media fueron menores en el grupo de laparoscopia. En cambio, el tiempo quirúrgico medio fue mayor en este grupo. El promedio de ganglios pélvicos y aórticos obtenidos fue superior en el grupo laparoscópico (p<0,001). El número de complicaciones fue similar con ambas vías (p=0,26). En el grupo laparoscópico no hubo ningún caso de conversión a laparotomía. Las dos poblaciones estudiadas fueron similares en características basales y en variables histopatológicas. En el análisis multivariable, ajustado para diferentes variables clínicas y morfológicas, las únicas variables con valor pronóstico independiente para supervivencia global fueron el grado mal diferenciado, la edad y el estadio IVa. Para tiempo libre de enfermedad lo fueron el tipo histológico de alto riesgo, la edad y el estadio IVa. Se concluye que la estadificación quirúrgica del cáncer de endometrio mediante abordaje laparoscópico-vaginal es factible y segura, con menor morbilidad y estancia hospitalaria. No obstante, se requiere un ensayo clínico que pueda confirmar estos resultados.Endometrial cancer is currently the most frequent malignancy of the female lower genital tract in developed countries. Stratification of tumor extension is based on surgical findings and pathological examination of the resected specimen. Routine treatment is carried out through a standard laparotomy, although some studies have suggested that the operation can be performed by laparoscopic-vaginal approach with the same level of oncological radicality and without increasing the rate of complications. The purpose of this study was to assess the feasibility of laparoscopy in the surgical treatment of clinical stage I endometrical carcinoma and to compare and the results obtained with those of laparotomy. The primary objective of the study was the comparison between both procedures in terms of overall survival, disease-free survival, and rate of complications. Secondary objectives included a comparison of surgical data, retrieved retroperitoneal lymph nodes, and length of hospital stay. Surgical stratification in both procedures included peritoneal cytology, extrafascial hysterectomy with bilateral salpingoophorectomy, bilateral pelvic lymphadenectomy ± para-aortic lymphadenectomy and omentectomy, and random biopsies in high-risk histological types. Most data were recorded prospectively. All patients with a diagnosis of primary endometrical carcinoma, stage I, attended at the Hospital Materno-infantil Vall d'Hebron in whom surgery was indicated as the primary treatment modality were included. The SPSS, version 11.0, software computer progarm was used for the analysis of data. Tests of normality, non-parametric tests, the Kaplan-Meier test for the analysis of overall survival and disease-free survival with the long-rank test for the comparison of survival curves, and a Cox proportional regression analysis were used. Between January 1995 and June 2001, a total of 371 patients with clinical stage I endometrial cancer were included. Stratification of the disease was made by the laparoscopic-vaginal approach in 55 patients (14.88%) and by laparotomy in 315 (84.9%). The mean age of the patients was 64.3 years and the body mass index 30 kg/m2 (range 18-57). Optimal stratification surgery was achieved in 367 patients (98.9%), without significant differences between both surgical routes. A total of 91.1% of patients underwent pelvic lymphadenectomy and 50% para-aortic lymphadenectomy. Positive lymph nodes were found in 41 cases (11.1%) and a total of 32 relapses (8.6%) were documented at follow-up. Edometrioid carcinoma was the most frequent (74%) histological type followed by the high-risk group (serous papillary, clear cell, and adenosquamous) (16%). In 27.3% of cases, the tumor was poorly differentiated (G3). Distribution of cases according to FIGO stage included stage I in 58% of cases, stage II in 24%, stage III in 16%, and stage IV in 2%. After a mean follow-up of 40.7 months, the overall survival rate was 92.2% (mean survival 93 months), with 90% for the laparotomy group and 100% for the laposcopic group. Differences in survival between both groups were not statistically significant (P=0.06). Disease-free survival for all patients was 91.4% (mean 93.2 months), with 92% for the laparotomy approach and 98.2% for the laparoscopic group. Differences in disease-free survival between both procedures were not statistically significant (P=0.09). However, there were significant differences (P<0.001) between both surgical routes with regard to operative data: mean blood loss, number of blood transfusions required, and mean length of hospital stay, which were lower in the laparoscopic group. In contrast, the mean surgical time was significantly longer in this group. The mean number of pelvic and aortic nodes recovered was higher in the laparoscopic group (P<0.001). The number of complications was similar for both routes (P=0.26). In patients undergoing surgery through the laparoscopic approach, no case of conversion to laparotomy was necessary. The two study populations were similar in baseline characteristics and histopathological variables. In the multivariate analysis and after adjusting for different clinical and morphological parameters, independent variables significantly associated with survival were poorly differentiated histological grade, age, and stage IVa, whereas independent predictors of disease-free survival were high-risk histological type, age, and stage IVa. It is concluded that surgical stratification of endometrial cancer by means of laparoscopic-vaginal approach is feasible and safe, with lower morbidity and shorter length of hospital stay. However, these results should be confirmed in the framework of a clinical trial

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Una práctica habitual para obtener evidencia de validez de modelos teóricos basados en los resultados del Análisis Factorial Exploratorio -EFA-, (Arruda et. al., 1996), suele ser utilizar el Análisis Factorial Confirmatorio (CFA) para demostrar la validez de la estructura factorial previamente obtenida con EFA y por consiguiente la validez de las deducciones teóricas inferidas del mismo, es decir, los modelos obtenidos con EFA suelen ser validados con CFA. El objetivo de este artículo es incidir en la posible redundancia de este procedimiento usado en validez de constructo. Se intenta mostrar que generalmente CFA siempre validará las soluciones obtenidas previamente mediante EFA, dado que la estructura factorial resultante de EFA es una de las posibles soluciones que se derivan de la matriz de datos y, por consiguiente, es previsible que en otra muestra extraída de la misma población de referencia, se confirme la estructura obtenida en la anterior. En este sentido, el binomio EFA-CFA, puede ser considerado como un pseudoprocedimiento para la validación de constructo.The results of exploratory factor analysis (EFA) are usually used to deduce theoretical models (Arruda et. al., 1996) and then confirmatory factor analysis (CFA) is used to demonstrate the construct validity of those deductions. Therefore, models obtai - ned from the former are ussually validated using latter. The object of this study is to demonstrate the redundancy of this procedure in construct validation. It will be shown that, usually, CFA will validate solutions obtained using EFA. This article emphasizes that this type of procedure does not offer definitive information about the construct validity of the solutions obtained using exploratory factor analysis. In this sense, the EFA-CFA binomial could be considered as a pseudo construct validation

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