Outcomes of GatekeeperTM prosthesis implantation for the treatment of fecal incontinence: a multicenter observational study.

BACKGROUND: The implantation of Gatekeeper ™ (GK) represents a new option for the treatment of fecal incontinence (FI). The aim of this study was to analyze the postoperative morbidity associated with GK and to determine its clinical efficacy after at least 1 year of follow-up. METHODS: This was a multicenter, retrospective and longitudinal study of patients with FI who were treated with GK at our institutions between January 2010 and December 2015. Patients with FI without sphincter lesions or with sphincter injuries < 120° and with low anterior resection syndrome were included. Postoperative complications, long-term adverse effects and migration were recorded. FI severity was assessed using the Vaizey score. Patients were classified as responders or non-responders according to the improvement of the Vaizey score (≥ than 50 and < 50%, respectively) during the first 6 months after implantation. RESULTS: Forty-nine consecutive patients treated with GK between 2010 and 2015 were included (11 males and 38 females, mean age 63.3 years, SD 13.5). No postoperative and long-term complications were observed. Prosthesis migration was observed in 51% of patients. Twenty-three patients (48%) were classified as responders and 25 (52%) as non-responders. The mean Vaizey score at baseline, 6, 12 months and last visit post-surgery in the responder group was, respectively, 13.3 (SD 3.8), 4.3 (SD 2.1), 4.2 (SD 3.6) and 5.7 (SD 5.3). Significant differences were observed between the mean baseline Vaizey score and the mean 6, 12 and last follow-up Vaizey score values (p < 0.001). In long-term follow-up (2.7 years (SD 1.1)), responders maintained an improvement of more than 50% of the baseline Vaizey score. In the non-responder group the mean number of migrated prostheses was higher than in the responder group (2.4 SD 2.5 vs. 1.0 SD 1.6; p = 0.040). CONCLUSIONS: GK is a safe and effective procedure in more than 50% of the patients for at least 1 year after the implantation.

Tratamiento de la enfermedad hemorroidal mediante desarterialización y hemorroidopexia. Experiencia de varias unidades especializadas / Treatment of haemorrhoids by transanal haemorrhoidal dearterialization. Experience of several specialized units

INTRODUCCIÓN: Durante varias décadas, las hemorroidectomías de Milligan-Morgan y Ferguson han sido la referencia en el tratamiento de la enfermedad hemorroidal sintomática. Sin embargo las técnicas escisionales llevan asociadas una morbilidad no despreciable. En los últimos años han surgido una serie de técnicas dedicadas a disminuir estos problemas. La desarterialización hemorroidal transanal (THD) guiada por doppler es una de estas técnicas. El objetivo de este estudio es analizar sus resultados según la experiencia de varias unidades especializadas. MÉTODOS: El estudio se realizó en 5 hospitales de la red pública de España. Se analizan y comparan los resultados pre- y posquirúrgicos, así como la homogeneidad interhospitalaria de dicha técnica. Se recogieron de forma prospectiva consecutiva datos de un total de 475 pacientes intervenidos mediante THD, la mayoría con hemorroides grado III(267 casos [56%]). RESULTADOS: La técnica anestésica preferida fue la anestesia raquídea, en un total de 398 casos (81%). Encontramos mejoría global tras la intervención ya que existen diferencias estadísticamente significativas entre síntomas pre- y postoperatorios (p = 0,03). La estancia media fue de 0,4 ± 0,3 días. Los días de analgesia media fueron 8,8 ± 2,7 días (paracetamol y AINE). La tasa acumulada de complicaciones fue del 16%. CONCLUSIONES: La THD es una técnica segura y fácilmente reproducible. Los resultados posquirúrgicos generan una escasa morbilidad, con una estancia hospitalaria muy reducida que permite una rápida reincorporación a la vida laboral, y una tasa de recurrencia baja

INTRODUCTION: Milligan-Morgan and Ferguson haemorrhoidectomy has been the gold standard treatment for symptomatic haemorrhoids for many years. However, escisional techniques are associated with a significant morbidity rate. In recent years, diverse techniques have been described in an attempt to decrease these complications. The guided transanal haemorrhoidal dearterialization THD) doppler is one of these techniques. We report our experience with this new technique. METHODS: We performed a prospective study of 475 patients from 5 hospitals from the National Health System, in Spain. The majority of these patients suffered from third grade haemorrhoids (256 [56%]) and underwent THD. We analyse and compare preoperative and postoperative results as well as the homogeneity of the technique between hospitals. RESULTS: Spinal anaesthesia was the most elected procedure by the anaesthetist (81.0%). Statistically significant differences were found between pre and postoperative symptoms (P = .03), with an overall improvement after surgery. The average hospitalization was 0.4 ± 0.3 days. The mean number of days of oral analgesics was 8.8 ± 2.7 days. The cumulative complication rate is 16%. CONCLUSION: THD is a safe and easily reproducible procedure. Postoperative outcomes demonstrated a low rate of morbidity and recurrence together with early discharge; therefore, a rapid incorporation to daily activities was noted

Treatment of haemorrhoids by transanal haemorrhoidal dearterialization. Experience of several specialized units.

INTRODUCTION: Milligan-Morgan and Ferguson haemorrhoidectomy has been the gold standard treatment for symptomatic haemorrhoids for many years. However, escisional techniques are associated with a significant morbidity rate. In recent years, diverse techniques have been described in an attempt to decrease these complications. The guided transanal haemorrhoidal dearterialization THD) doppler is one of these techniques. We report our experience with this new technique. METHODS: We performed a prospective study of 475 patients from 5 hospitals from the National Health System, in Spain. The majority of these patients suffered from third grade haemorrhoids (256 [56%]) and underwent THD. We analyse and compare preoperative and postoperative results as well as the homogeneity of the technique between hospitals. RESULTS: Spinal anaesthesia was the most elected procedure by the anaesthetist (81.0%). Statistically significant differences were found between pre and postoperative symptoms (P=.03), with an overall improvement after surgery. The average hospitalization was 0.4±0.3 days. The mean number of days of oral analgesics was 8.8±2.7 days. The cumulative complication rate is 16%. CONCLUSION: THD is a safe and easily reproducible procedure. Postoperative outcomes demonstrated a low rate of morbidity and recurrence together with early discharge; therefore, a rapid incorporation to daily activities was noted.

Variación del valor pronóstico de la proteína p53 en relación con el estadio tumoral en pacientes con adenocarcinoma colorrectal / Variation in the prognostic value of p53 protein in relation to tumoral stage in patients with colorectal adenocarcinoma

Objetivo. Analizar el valor pronóstico que posee la proteína p53 en cada estadio tumoral, como indicador de riesgo de recidiva. Pacientes y método. Estudio prospectivo de una cohorte de 288 pacientes intervenidos por adenocarcinoma colorrectal. Cuarenta y dos pacientes (14,6%) se encontraban en estadio I de la clasificación TNM (tu-mor-nodo-metástasis); 144 (50%), en estadio II, y 102 (35,4%), en estadio III. Se analizaron, en muestras tu-morales fijadas en formol y parafinadas, variables histopatológicas y se determinaron mediante inmunohistoquímica las proteínas p53 (anticuerpo DO7) y PCNA (proliferative cell nuclear antigen) (anticuerpo PC10). Se analizaron los resultados de p53 en cada una de las categorías de las variables clínicas e histopatológicas. Se calculó la supervivencia sin recidiva mediante el método de Kaplan-Meier. Se analizó el valor de cada variable como indicador predictivo de aparición de recidiva tumoral mediante análisis de regresión de Cox. Se calcularon las hazard ratio y los intervalos de confianza (IC) del 95%, como indicadores del riesgo relativo. El análisis se aplicó en toda la cohorte de pacientes y, posteriormente, fue repetido en cada estadio tumoral TNM por separado. Resultados. Los tumores con sobreexpresión de proteína p53 desarrollaron con mayor frecuencia recidiva tumoral y presentaron menor supervivencia sin recurrencia a los 5 años de seguimiento. Sin embargo, únicamente en los tumores en estadio III la asociación entre expresión de p53 y evolución postoperatoria alcanzó significación estadística. En este subgrupo de pacientes, la supervivencia sin recidiva a los 60 meses de seguimiento fue del 60% en los tumores con p53 negativo y del 26% en aquellos con p53 positivo (p = 0,010). En el análisis multivariante, p53 se mostró como un factor pronóstico independiente asociado a un riesgo elevado de recidiva en tumores en estadio III (hazard ratio = 2,76; IC del 95%, 1,29-5,9; p = 0,009). La sobreexpresión de p53 aportó valor pronóstico como indicador de riesgo elevado de recidiva en forma de metástasis (hazard ratio = 2,23; IC del 95%, 1,04-4,75) y no como factor pronóstico de recidiva locorregional. No se observó relación entre el estado de la proteína p53 y el efecto de la quimioterapia adyuvante postoperatoria. Conclusión. La proteína p53 no posee el mismo valor como factor pronóstico en todos los estadios tu-morales. Esta proteína únicamente posee valor predictivo indicativo de riesgo elevado de recidiva en el subgrupo de pacientes con tumores en estadio III (AU)

Objective. To analyze the prognostic value of p53 protein as a marker of recurrence risk in each tumoral stage. Patients and method. A prospective study of a cohort of 288 patients who underwent surgery for colo-rectal adenocarcinoma was performed. Stage 1 of the tumor-node-metastasis (TNM) classification was found in 42 patients (14.6%), stage II in 144 (50%) and stage III in 102 (35.4%). Histopathological variables were examined in tumor samples fixed in formol and embedded in paraffin and p53 (DO7 antibody) and proliferative cell nuclear antigen (PC-10 antibody) proteins were determined using immunohistochemistry. The results of p53 were analyzed in each of the categories of clinical and histopathological variables. Recurrence-free survival was calculated using the Kaplan-Meier method. The value of each variable as a predictive marker for tumoral recurrence was analyzed using Cox regression analysis. Hazard ratios and 95% confidence intervals were calculated as indicators of relative risk. The analysis was applied to the whole cohort and was subsequently repeated in each TNM tumoral stage separately. Results. Tumors with p53 protein overexpression more frequently recurred and showed lower recurren-ce-free survival at 5 years. However, the association between p53 expression and postoperative outcome was statistically significant in stage III tumors only. In this subgroup of patients, recurrence-free survival at 60 months was 60% in p53-negative tumors and was 26% in p53-positive tumors (p = 0.010). In the multivariate analysis, p53 was an independent prognostic factor associated with a high risk of recurrence in stage III tumors (hazard ratio = 2.76; 95% CI, 1.29-5.9; p = 0.009). Overexpression of p53 showed prognostic value as a marker of high risk of recurrence in the form of metastases (hazard ratio = 2.23; 95% CI, 1.04-4.75), but not as a prognostic marker of locoregional recurrence. No relationship was found between the state of p53 protein and the effect of postoperative adjuvant therapy. Conclusion. The p53 protein does not have the same prognostic value in all tumoral stages. This protein is only predictive of high recurrence risk in the subgroup of patients with stage III tumors (AU)

[Variation in the prognostic value of p53 protein in relation to tumoral stage in patients with colorectal adenocarcinoma]. / Variación del valor pronóstico de la proteína p53 en relación con el estadio tumoral en pacientes con adenocarcinoma colorrectal.

OBJECTIVE: To analyze the prognostic value of p53 protein as a marker of recurrence risk in each tumoral stage. PATIENTS AND METHOD: A prospective study of a cohort of 288 patients who underwent surgery for colorectal adenocarcinoma was performed. Stage 1 of the tumor-node-metastasis (TNM) classification was found in 42 patients (14.6%), stage II in 144 (50%) and stage III in 102 (35.4%). Histopathological variables were examined in tumor samples fixed in formol and embedded in paraffin and p53 (DO7 antibody) and proliferative cell nuclear antigen (PC-10 antibody) proteins were determined using immunohistochemistry. The results of p53 were analyzed in each of the categories of clinical and histopathological variables. Recurrence-free survival was calculated using the Kaplan-Meier method. The value of each variable as a predictive marker for tumoral recurrence was analyzed using Cox regression analysis. Hazard ratios and 95% confidence intervals were calculated as indicators of relative risk. The analysis was applied to the whole cohort and was subsequently repeated in each TNM tumoral stage separately. RESULTS: Tumors with p53 protein overexpression more frequently recurred and showed lower recurrence-free survival at 5 years. However, the association between p53 expression and postoperative outcome was statistically significant in stage III tumors only. In this subgroup of patients, recurrence-free survival at 60 months was 60% in p53-negative tumors and was 26% in p53-positive tumors (p=0.010). In the multivariate analysis, p53 was an independent prognostic factor associated with a high risk of recurrence in stage III tumors (hazard ratio=2.76; 95% CI, 1.29-5.9; p=0.009). Overexpression of p53 showed prognostic value as a marker of high risk of recurrence in the form of metastases (hazard ratio=2.23; 95% CI, 1.04-4.75), but not as a prognostic marker of locoregional recurrence. No relationship was found between the state of p53 protein and the effect of postoperative adjuvant therapy. CONCLUSION: The p53 protein does not have the same prognostic value in all tumoral stages. This protein is only predictive of high recurrence risk in the subgroup of patients with stage III tumors.