Multicentre, prospective, randomized control non-inferiority trial of bladder catheter management in colon surgery.

AIM: Perioperative bladder catheterization is a controversial issue. Most current recommendations are based on data from open surgery extrapolated to enhanced recovery after surgery or fast-track programmes ranging between 24 and 48 h. The aim of this study is to provide a rationale for reducing catheterization time while at the same time avoiding acute urine retention (AUR), in patients undergoing scheduled laparoscopic colon surgery. METHOD: This is a multicentre, prospective, controlled, randomized non-inferiority study of bladder catheter management in patients undergoing scheduled laparoscopic colon surgery, randomized into two groups: experimental (with catheter removal immediately after surgery) and control (with catheter removal 24 h post-surgery). The main outcome will be the development of AUR, and secondary outcomes the development of urinary infection within the first 30 days and hospital stay. Demographic, surgical and pathological variables will also be evaluated, especially the development of adverse effects assessed according to the Clavien scale and the Comprehensive Complication Index. Following the literature, we assume an incidence of AUR of 11% and a margin of non-inferiority (delta) of 8% and estimate that a sample size of 208 patients per group will be required (with an estimated 10% of losses per group). CONCLUSIONS: In this study we try to demonstrate that the bladder catheter can be removed immediately after scheduled laparoscopic colon surgery, without increasing acute urine retention. This measure would offers the benefits of earlier mobilization and reduces catheter-related morbidity.

Multicenter Controlled Study of Intracorporeal Mechanical Side-to-Side Isoperistaltic Anastomosis versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-Study.

Colorectal cancer is the second most frequent cancer in the Western world. A third of colorectal tumors are located in the right colon, and right hemicolectomy is the treatment in nondisseminated right colon cancer. The most serious complication of this procedure is anastomotic leak, which occurs in 8.4% of cases. At present, there is no standardized technique for laparoscopic ileo-colic anastomosis. In previous observational studies, intracorporeal side-to-side ileo-colic laparoscopic anastomosis has shown better results than extracorporeal anastomosis in terms of morbidity and mortality. It is known that randomized studies provide higher levels of evidence, but multicenter randomized controlled studies may imply a learning curve bias due to the differences in technical experience acquired at each hospital. As a result, we propose to carry out a prospective, controlled, nonrandomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND) in a large sample of 416 patients (208 per group) in order to assess the use of intracorporeal side-to-side ileo-colic laparoscopic anastomosis as the gold standard in right hemicolectomy.

Correlation between intraoperative surgical diagnosis of complicated acute appendicitis and the pathology report: clinical implications.

BACKGROUND: The post-operative management of appendectomy for acute appendicitis is based primarily on the operative findings. The surgeon describes the severity of the disease, and antibiotic therapy is administered accordingly. The histologic findings are not always considered in the decision about the management and may not be correlated with the clinical outcome. The aim of this study was to investigate the agreement between the surgeon's intra-operative visual description of the appendix and the pathologist's report in a consecutive series of patients with acute appendicitis. Complications were analyzed in relation to the classification. METHODS: A comparative observational study was performed in 69 patients who underwent surgery for acute appendicitis at the same hospital during a one-year period (the entire year of 2011). The surgeon's classification of the severity of appendicitis was compared with the pathologist's report using the kappa coefficient. Patient demographics, surgical techniques, and post-operative complications also were analyzed. RESULTS: Complicated appendicitis (gangrenous or perforated) was considered to be present in 36.2% of patients in the surgeon's classification and 43% of the patients in the histopathologic reports (p=0.033). The kappa coefficient showed only a weak correlation between the surgeons' and pathologists' descriptions (κ=0.25). Significant differences in post-operative complications were found only in the surgeon's classification. CONCLUSION: We found a weak correlation between the surgeon's macroscopic diagnosis and the pathologic findings. However, the differences did not have meaningful clinical implications. Further studies are required to evaluate the clinical meaning of these results.

[A surgical safety checklist implementation: experience of a start-up phase of a collaborative project in hospitals of Catalonia, Spain]. / Implementación de un listado de verificación de prácticas seguras en cirugía: experiencia de la fase inicial de la puesta en marcha de un proyecto colaborativo en hospitales de Catalunya.

Surgical patient safety is a priority in the national and international quality healthcare improvement strategies. The objective of the study was to implement a collaborative intervention with multiple components and to evaluate the impact of the patient surgical safety checklist (SSC) application. This is a prospective, longitudinal multicenter study with a 7-month follow-up period in 2009 based on a collaborative intervention for the implementation of a 24 item-SSC distributed in 3 different stages (sign in, time out, sign out) for its application to the surgical patient. A total number of 27 hospitals participated in the strategy. The global implementation rate was 48% (95%CI, 47.6%-48.4%) during the evaluation period. The overall compliance with all the items of the SSC included in each stage (sign in, time out, sign out) was 75,1% (95%CI, 73.5%-76.7%) for the sign in, 77.1% (95%CI, 75.5%-78.6%) for the time out and 88.3% (95%CI, 87.2%-89.5%) for the sign out respectively. The individual compliance with each item of the SSC has remained above 85%, except for the surgical site marking with an adherence of 67.4% (95%CI, 65.7%-69.1%)] and 71.2% (95%CI, 69.6%-72.9%)] in the sign in and time out respectively. The SSC was successfully implemented to 48% of the surgeries performed to the participating hospitals. The global compliance with the SSC was elevated and the intervention trend was stable during the evaluation period. Strategies were identified to allow of a higher number of surgeries with application of the SSC and more professional involvement in measures compliance such as surgical site marking.

Implementación de un listado de verificación de prácticas seguras en cirugía: experiencia de la fase inicial de la puesta en marcha de un proyecto colaborativo en hospitales de Catalunya / A surgical safety checklist implementation: experience of a start-up phase of a collaborative project in hospitals of Catalonia, Spai

La seguridad en el paciente quirúrgico es un tema de alta prioridad en las estrategias de mejora de la calidad en atención sanitaria en los ámbitos nacional e internacional. El objetivo fue implementar una inte rvención colaborativa de múltiples componentes y evaluar su impacto en la aplicación de un listado de verificación quirúrgico (LVQ) de prácticas seguras en el paciente. Estudio prospectivo, longitudinal, multicéntrico, basado en la aplicación y seguimiento durante 7 meses en el año 2009 de una intervención colaborativa, para facilitar la implementación de un LVQ de 24 ítems distribuidos en 3 momentos de aplicación en el paciente quirúrgico, siendo estos los momentos de verificación preoperatoria (VP), pausa preoperatoria (PP) y verificación a la salida de quirófano (VS). Se adhirieron 27 hospitales a la estrategia. La implementación global fue del 48% (intervalo de confianza [IC] del 95%, 47,6-48,4). El cumplimiento de todos los ítems del LVQ para cada momento de aplicación fue de un 75,1% (IC del 95%, 73,5-76,7), un 77,1% (IC del 95%, 75,5-78,6) y un 88,3% (IC del 95%, 87,2-89,5) para la VP, la PP y la VS, respectivamente. El cumplimiento individual de cada ítem del LVQ se mantuvo por encima del 85%, excepto en la realización del marcaje, con un 67,4% (IC del 95%, 65,7-69,1) y un 71,2% (IC del 95%, 9,6-72,9) en la VP y PP, respectivamente. Se consiguió implementar el LVQ en el 48% de las cirugías en los hospitales participantes. El cumplimiento fue elevado y se mantuvo estable en el tiempo. Se identificaron estrategias para aumentar el alcance en el número de cirugías con aplicación del LVQ y más implicación de los profesionales en el cumplimiento de medidas tales como la realización del marcaje (AU)

Surgical patient safety is a priority in the national and international quality healthcare improvement strategies. The objective of the study was to implement a collaborative intervention with multiple components and to evaluate the impact of the patient surgical safety checklist (SSC) application. This is a prospective, longitudinal multicenter study with a 7-month follow-up period in 2009 based on a collaborative intervention for the implementation of a 24 item-SSC distributed in 3 different stages (sign in, time out, sign out) for its application to the surgical patient. A total number of 27 hospitals participated in the strategy. The global implementation rate was 48% (95%CI, 47.6%-48.4%) during the evaluation period. The overall compliance with all the items of the SSC included in each stage (sign in, time out, sign out) was 75,1% (95%CI, 73.5%-76.7%) for the sign in, 77.1% (95%CI, 75.5%-78.6%) for the time out and 88.3% (95%CI, 87.2%-89.5%) for the sign out respectively. The individual compliance with each item of the SSC has remained above 85%, except for the surgical site marking with an adherence of 67.4% (95%CI, 65.7%-69.1%)] and 71.2% (95%CI, 69.6%-72.9%)] in the sign in and time out respectively. The SSC was successfully implemented to 48% of the surgeries performed to the participating hospitals. The global compliance with the SSC was elevated and the intervention trend was stable during the evaluation period. Strategies were identified to allow of a higher number of surgeries with application of the SSC and more professional involvement in measures compliance such as surgical site marking (AU)

Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study.

BACKGROUND: Trocar site incisional hernia (TSIH) is a common complication after laparoscopic cholecystectomy. The aim of this study was to evaluate the prevalence of TSIH and analyze the influence of several risk factors for this complication in a prospective series. METHODS: From 2007 to 2008, a prospective observational study with 3 years of follow-up was performed including all consecutive patients with cholelithiasis who underwent elective laparoscopic cholecystectomy. A multivariate analysis was performed to identify risk factors for TSIH. RESULTS: Overall, 241 patients were included. During a median follow-up period of 46.8 months, 57 patients (25.9%) were diagnosed with umbilical TSIH by physical exam or ultrasound. The multivariate analysis revealed that incision enlargement (odds ratio [OR], 14.17; 95% confidence interval [CI], 3.61 to 55.51; P < .001), wound infection (OR, 5.62; 95% CI, 2.35 to 13.42; P < .001), diabetes mellitus (OR, 2.79; 95% CI, 1.05 to 7.37; P = .0038), and obesity (OR, 2.71; 95% CI, 1.28 to 5.75; P = .009) contributed to the risk for developing a TSIH. CONCLUSIONS: Umbilical TSIH is highly prevalent. This study identified several factors that could be useful to introduce preventive measures in high-risk patients.

Variación en las reclamaciones dirigidas a un Servicio de Cirugía General y del Aparato Digestivo tras un cambio estructural y funcional hospitalario / Changes in the complaints made to a General and Gastrointestinal Surgery Department after a change in hospital structure and function

Objetivo Las reclamaciones de un servicio médico son una medida de la calidad asistencial percibida por los pacientes. El objetivo del estudio fue analizar la variación producida en el porcentaje de reclamaciones dirigidas al Servicio de Cirugía General y del Aparato Digestivo (CGD) en relación a los cambios producidos por el traslado a un nuevo hospital. Material y métodos Estudio longitudinal del porcentaje de reclamaciones dirigidas al Servicio de CGD en dos periodos de 6 meses de un mismo año (periodos A y B). Entre uno y otro periodo se realizó el traslado a un nuevo hospital. Se compara el porcentaje de reclamaciones asociadas a la actividad hospitalaria y en consultas externas. Resultados El porcentaje de reclamaciones dirigidas al Servicio de CGD fue del 3,02% dirigidas a las altas de hospitalización y 0,44% dirigidas a la atención en consultas externas. Cuando se compararon ambos periodos, se observó una disminución estadísticamente significativa de las reclamaciones en hospitalización (A: 3,74% vs B: 2,20%, p=0,006) y en consultas externas (A: 0,53% vs. B: 0,34%, p=0,005). Se pudo constatar también que la disminución paralela de las reclamaciones de hospitalización y de consultas externas siguió una correlación lineal significativa (R:0,988 p<0,001).Conclusiones El cambio estructural y funcional por el traslado a un nuevo hospital comportó que el porcentaje de reclamaciones dirigidas al Servicio de CGD disminuyera de manera significativa en el periodo estudiado. Son necesarios estudios prospectivos y multicéntricos que permitan evaluar si estos resultados son superponibles a otros medios (AU)

Objective The complaints to a medical service are a measure of the quality of health care perceived by the patients. The aim of this study was to analyse the differences found in the percentage of complaints made to the General and Gastrointestinal Surgery Department (GGSD) with the changes made due to moving to a new hospital. Material and methods A longitudinal study of the percentage of complaints made to the GGSD in two 6 month periods in the same year (periods A and B). The Department was moved to a new hospital between the two periods. The percentage complaints associated with the hospital and outpatient activity is compared. Results The percentage complaints made to the GGSD was 3.02% directed at the hospital service and 0.44% to outpatient care. When both periods were compared, a statistically significant difference was observed in the hospital complaints (A: 3.74% vs B: 2.20%, P=.006) and in the outpatient complaints (A: 0.53% vs. B: 0.34%, P=.005). It could also be shown that there was a continuous significant correlation in the parallel decrease in the hospital and outpatient complaints (R:0.988P<.001).Conclusions The structural and functional change due to moving to a new hospital showed that the percentage of complaints made to the GGSD changed significantly in the period studied. Prospective multicentre studies are required to evaluate whether these results can be extrapolated to other services (AU)

[Changes in the complaints made to a General and Gastrointestinal Surgery Department after a change in hospital structure and function]. / Variación en las reclamaciones dirigidas a un Servicio de Cirugía General y del Aparato Digestivo tras un cambio estructural y funcional hospitalario.

OBJECTIVE: The complaints to a medical service are a measure of the quality of health care perceived by the patients. The aim of this study was to analyse the differences found in the percentage of complaints made to the General and Gastrointestinal Surgery Department (GGSD) with the changes made due to moving to a new hospital. MATERIAL AND METHODS: A longitudinal study of the percentage of complaints made to the GGSD in two 6 month periods in the same year (periods A and B). The Department was moved to a new hospital between the two periods. The percentage complaints associated with the hospital and outpatient activity is compared. RESULTS: The percentage complaints made to the GGSD was 3.02% directed at the hospital service and 0.44% to outpatient care. When both periods were compared, a statistically significant difference was observed in the hospital complaints (A: 3.74% vs B: 2.20%, P=.006) and in the outpatient complaints (A: 0.53% vs. B: 0.34%, P=.005). It could also be shown that there was a continuous significant correlation in the parallel decrease in the hospital and outpatient complaints (R:0.988 P<.001). CONCLUSIONS: The structural and functional change due to moving to a new hospital showed that the percentage of complaints made to the GGSD changed significantly in the period studied. Prospective multicentre studies are required to evaluate whether these results can be extrapolated to other services.

Bowel habits and fecal incontinence in patients with obesity undergoing evaluation for weight loss: the importance of stool consistency.

BACKGROUND: Fecal incontinence is highly prevalent in the general population and especially in risk groups. Obesity is also common and is associated with comorbidities that impair general health and interfere with daily activities. Identifying mutable factors for fecal incontinence, such as stool consistency, is of paramount importance to improve quality of life. OBJECTIVE: The aim of this study was to estimate the prevalence of fecal incontinence in patients with obesity undergoing evaluation for weight loss, its relationship with bowel habits, and its impact on quality of life. DESIGN: This investigation is a cross-sectional observational study. SETTINGS: This study was conducted in patients with obesity who were undergoing evaluation for weight loss. MAIN OUTCOME MEASURES: Fecal incontinence was defined as loss of flatus or liquid/solid stool occurring at least monthly. Data on comorbidities, BMI, quality of life, bowel habits including stool consistency measured with the Bristol Stool Form Scale, and symptoms of fecal incontinence were collected. RESULTS: Fifty-two patients were included, with a mean BMI of 39.6 kg/m2. Symptoms of fecal incontinence were found in 17 patients (32.7%): flatus in 9 of 17 (52.9%), liquid stool in 6 of 17 (35.2%), and solid stool in 2 of 17 (11.7%). No differences were found between patients with and without fecal incontinence in age, sex, comorbidities, or BMI. Health-related quality of life was lower in patients with fecal incontinence than in those without, but this difference was not significant, with the exception of the dimensions of role-physical (p = 0.03) and social functioning (p = 0.04). Patients with incontinence reported significantly higher percentages of altered bowel habits with nonformed stools (p = 0.004). LIMITATIONS: The cross-sectional design hampered identification of the time at which the impact of obesity occurred. CONCLUSIONS: Fecal incontinence is common in patients with obesity. Stool consistency was significantly different in these patients. This study supports the possibility of improving incontinence during weight loss by modifying stool consistency.

Prospective analysis of clinician accuracy in the diagnosis of benign anorrectal pathology: the value of clinical information.

AIM: the prevalence of anorectal disorders in general population is high. The aim of this study was to analyze the influence of clinical symptoms on diagnostic accuracy for benign anorectal pathology among different specialists and evaluate the relationship between diagnostic accuracy and years of professional experience. METHODS: seven typical cases were selected. In a first interview, participants were shown images and asked to make a diagnosis. Afterwards, images with additional information (clinical symptoms) were used. Two groups (group 1 = general surgeons and group 2 = medical specialists who attended emergency department) completed both phases of the study to analyze the influence of clinical symptoms on the final diagnosis. RESULTS: forty four specialists were interviewed. The percentage of participants making a correct diagnosis in groups 1 and 2, respectively, was as follows: case 1 (perianal abscess): 100 vs. 80.6%, (p = 0.157); case 2 (fissure): 92.3 vs. 51.6% (p = 0.015); case 3 (thrombosed hemorrhoid): 92.3 vs. 74.2% (p = 0.321); case 4 (anal condyloma): 100 vs. 87.1% (p = 0.302); case 5 (rectal prolapse): 100 vs. 83.9% (p = 0.301); case 6 (prolapsed hemorrhoid): 92.3 vs. 29% (p = 0.001), and case 7 (fistula): 100 vs. 67.7% (p = 0.021). There were significant differences in the number of correctly diagnosed cases between groups (p < 0.001). Information about clinical symptoms significantly increased overall and specific accuracy. There was no correlation between experience and accuracy. CONCLUSIONS: clinical symptoms are important for diagnostic accuracy in anorectal pathology. Training in anorectal pathology in medical specialists is warranted.

Análisis prospectivo de la precisión diagnóstica en la patología anorrectal benigna: importancia de la información clínica / Prospective analysis of clinician accuracy in the diagnosis of benign anorectal pathology: the value of clinical information

Objetivo: la prevalencia de los trastornos anorrectales benignos en la población general es alta. El objetivo de este estudio es analizar la influencia de los síntomas clínicos en la precisión diagnóstica de la patología benigna anorrectal entre los diferentes especialistas y evaluar la relación entre el diagnóstico de la enfermedad y los años de experiencia profesional entre los profesionales participantes. Pacientes y métodos: se seleccionaron 7 casos típicos. En una primera entrevista, se mostró a los participantes las imágenes clínicas de cada caso y se les pidió que formularan un diagnóstico. Posteriormente, se volvió a mostrar las mismas imágenes con información clínica adicional. Dos grupos (grupo 1 = especialistas en cirugía general y digestiva y grupo 2 = especialistas de especialidades médicas con asistencia en el área de urgencias) completaron las dos fases del estudio para analizar la influencia de los síntomas clínicos en el diagnóstico final. También se analizó la relación entre la precisión diagnóstica y los años de experiencia de cada profesional. Resultados: se entrevistaron a 44 especialistas. El porcentaje de participantes que realizó un diagnóstico correcto en el grupo 1 y 2, fue respectivamente: caso 1 (absceso perianal): 100 vs. 80.6%, (p = 0,157); caso 2 (fisura anal): 92,3 vs. 51.6% (p = 0,015); caso 3 (hemorroide trombosada): 92,3 vs. 74,2% (p = 0,321); caso 4 (condiloma anal): 100 vs. 87,1% (p = 0,302); caso 5 (prolapso rectal): 100 vs. 83.9% (p = 0,301); caso 6 (prolapso hemorroidal): 92,3 vs. 29% (p = 0,001), y caso 7 (fístula perianal): 100 vs. 67,7% (p = 0,021). Se observaron diferencias en el número de los diagnósticos correctos entre grupos (p < 0,001). Globalmente, la información sobre síntomas clínicos incrementó significativamente la precisión específicamente, no observándose correlación entre experiencia profesional y precisión. Conclusiones: los síntomas clínicos son importantes para la precisión diagnóstica de la patología anorrectal benigna. La formación específica de especialistas médicos en esta patología anorrectal está claramente justificada(AU)

Aim: the prevalence of anorectal disorders in general population is high. The aim of this study was to analyze the influence of clinical symptoms on diagnostic accuracy for benign anorectal pathology among different specialists and evaluate the relation ship between diagnostic accuracy and years of professional expe rience. Methods: seven typical cases were selected. In a first interview, participants were shown images and asked to make a diagnosis. Afterwards, images with additional information (clinical symptoms) were used. Two groups (group 1 = general surgeons and group 2 = medical specialists who attended emergency department) completed both phases of the study to analyze the influence of clinical symptoms on the final diagnosis. Results: forty four specialists were interviewed. The percentage of participants making a correct diagnosis in groups 1 and 2, respectively, was as follows: case 1 (perianal abscess): 100 vs. 80.6%, (p = 0.157); case 2 (fissure): 92.3 vs. 51.6% (p = 0.015); case 3 (thrombosed hemorrhoid): 92.3 vs. 74.2% (p = 0.321); case 4 (anal condyloma): 100 vs. 87.1% (p = 0.302); case 5 (rectal prolapse): 100 vs. 83.9% (p = 0.301); case 6 (prolapsed hemorrhoid): 92.3 vs. 29% (p = 0.001), and case 7 (fistula): 100 vs. 67.7% (p = 0.021). There were significant differences in the number of correctly diagnosed cases be - tween groups (p < 0.001). Information about clinical symptoms significantly increased overall and specific accuracy. There was no correlation between experience and accuracy. Conclusions: clinical symptoms are important for diagnostic accuracy in anorectal pathology. Training in anorectal pathology in medical specialists is warranted(AU)

Efectos adversos en cirugía general. Análisis prospectivo de 13. 950 pacientes consecutivos / Adverse events in general surgery. a prospective analysis of 13, 950 consecutive patients

Las cifras de efectos adversos (EA) en cirugía general varían según los diferentes autores y metodologías de recogida entre un 2 y un 30%. Diseñamos hace 6 años un sistema prospectivo de recogida de EA para cambiar la cultura de seguridad del paciente en nuestro servicio. Presentamos los resultados de este trabajo tras 6 años de seguimiento. Material y método Recogida prospectiva de los EA, secuelas y errores asistenciales en un servicio de cirugía de un hospital universitario. Análisis mediante revisor de cada incidente recogido. Los datos se recogen en una base de datos de acceso y consulta inmediata. Los resultados se exponen rutinariamente en sesiones de morbimortalidad del servicio. Resultados Un total de 13.950 pacientes han sufrido 11.254 EA que han afectado a 5.142 de ellos (36,9% de los ingresos). Un total de 920 pacientes han presentado al menos un error asistencial (6,6% de los ingresos). Esto significa que el 6,6% de nuestros pacientes sufren EA evitables. La mortalidad global de nuestro servicio en estos 5 años es de 2,72% (380 exitus). En 180 casos un EA ha estado implicado en la mortalidad del paciente (1,29% de los ingresos). En 49 casos, esta mortalidad puede atribuirse a un EA evitable (0,35% de los ingresos). Tras 6 años se tiende a cada vez menor presentación de errores. Conclusiones La recogida exhaustiva y prospectiva de EA cambia la cultura de seguridad del paciente en un servicio de cirugía y permite disminuir la incidencia de errores asistenciales (AU)

Introduction Adverse event (AE) rates in General Surgery vary, according to different authors and recording methods, between 2% and 30%. Six years ago we designed a prospective AE recording system to change patient safety culture in our Department. We present the results of this work after a 6 year follow-up. Material and method The AE, sequelae and health care errors in a University Hospital surgery department were recorded. An analysis of each incident recorded was performed by a reviewer. The data was entered into data base for rapid access and consultation. The results were routinely presented in Departmental morbidity-mortality sessions. Results A total of 13,950 patients had suffered 11,254 AE, which affected 5142 of them (36.9% of admissions). A total of 920 patients were subjected to at least one health care error (6.6% of admissions). This meant that 6.6% of our patients suffered an avoidable AE. The overall mortality at 5 years in our department was 2.72% (380 deaths). An adverse event was implicated in the death of the patient in 180 cases (1.29% of admissions). In 49 cases (0.35% of admissions), mortality could be attributed to an avoidable AE. After 6 years there tends to be an increasingly lower incidence of errors. Conclusions The exhaustive and prospective recording of AE leads to changes in patient safety culture in a Surgery Department and helps decrease the incidence of health care errors (AU)

[Adverse events in general surgery. A prospective analysis of 13,950 consecutive patients]. / Efectos adversos en cirugía general. Análisis prospectivo de 13.950 pacientes consecutivos.

INTRODUCTION: Adverse event (AE) rates in General Surgery vary, according to different authors and recording methods, between 2% and 30%. Six years ago we designed a prospective AE recording system to change patient safety culture in our Department. We present the results of this work after a 6 year follow-up. MATERIAL AND METHOD: The AE, sequelae and health care errors in a University Hospital surgery department were recorded. An analysis of each incident recorded was performed by a reviewer. The data was entered into data base for rapid access and consultation. The results were routinely presented in Departmental morbidity-mortality sessions. RESULTS: A total of 13,950 patients had suffered 11,254 AE, which affected 5142 of them (36.9% of admissions). A total of 920 patients were subjected to at least one health care error (6.6% of admissions). This meant that 6.6% of our patients suffered an avoidable AE. The overall mortality at 5 years in our department was 2.72% (380 deaths). An adverse event was implicated in the death of the patient in 180 cases (1.29% of admissions). In 49 cases (0.35% of admissions), mortality could be attributed to an avoidable AE. After 6 years there tends to be an increasingly lower incidence of errors. CONCLUSIONS: The exhaustive and prospective recording of AE leads to changes in patient safety culture in a Surgery Department and helps decrease the incidence of health care errors.

Eventración de los orificios de los trocares en cirugía laparoscópica / Trocar site incisional hernia in laparoscopic surgery

La eventración de los orificios de los trocares (EOT) es la más frecuente complicación de la cirugía laparoscópica. Hemos realizado una revisión de la literatura con el fin de establecer su incidencia, las causas de aparición de las mismas y su prevención. Tras una búsqueda en las base de datos MEDLINE PubMed y PubMed CENTRAL desde 1991 hasta 2009, combinando las palabras: «hernia», «laparoscopy» y «trocar», obtuvimos 545 artículos de los cuales analizamos 60. La incidencia de las EOT oscila entre el 0,18 y 2,8%. El diámetro del trocar, la obesidad y la edad juegan un papel primordial a la hora de proceder al cierre de la fascia, cierre que es el factor más importante para prevenir la aparición de dichas eventraciones. La aparición de nuevo material de laparoscopia y el cierre cada vez más frecuente de los defectos de la fascia hace necesarios nuevos y más extensos estudios prospectivos (AU)

Trocar site incisional hernias (TSIH) are the most common complications in laparoscopic surgery. We have carried out a review of the literature with the aim of establishing their incidence, the reasons for them happening, and their prevention. After a search in the MEDLINE PubMed and PubMed CENTRAL data bases from 1991 to 2009, combining the words: «hernia», «laparoscopy» and «trocar», we obtained 545 articles, of which we analysed 60 of them. The incidence of TSIH varies between 0.18% and 2.8%. The diameter of the trocar, obesity and age play a fundamental role when proceeding to close the fascia, a closure which is the most important factor to prevent these incisional hernias appearing. The appearance of new laparoscopic material and the increasing more common closure of defects of the fascia means that new and more extensive prospective studies should be performed (AU)

[Trocar site incisional hernia in laparoscopic surgery]. / Eventración de los orificios de los trocares en cirugía laparoscópica.

Trocar site incisional hernias (TSIH) are the most common complications in laparoscopic surgery. We have carried out a review of the literature with the aim of establishing their incidence, the reasons for them happening, and their prevention. After a search in the MEDLINE PubMed and PubMed CENTRAL data bases from 1991 to 2009, combining the words: "hernia", "laparoscopy" and "trocar", we obtained 545 articles, of which we analysed 60 of them. The incidence of TSIH varies between 0.18% and 2.8%. The diameter of the trocar, obesity and age play a fundamental role when proceeding to close the fascia, a closure which is the most important factor to prevent these incisional hernias appearing. The appearance of new laparoscopic material and the increasing more common closure of defects of the fascia means that new and more extensive prospective studies should be performed.

Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery.

BACKGROUND: This study was designed to determine the incidence of adverse events and errors in the care of surgical patients and to demonstrate that continuous prospective collection of data on adverse events can improve quality of care and reduce the number of errors. Retrospective studies find adverse events in approximately 5% of patients admitted. Prospective studies publish figures of approximately 30%. No studies to date have tried to use continuous collection of data on adverse events to reduce the incidence of errors. METHODS: Longitudinal prospective surveillance of adverse events in patients admitted to the Surgery Service during a 22-month period. Sequelae after discharge and errors during hospital stay were evaluated by peer review. RESULTS: A total of 3,807 patients were controlled: 1,177 patients presented 2,193 adverse events (30.9% of admissions); 330 adverse events due to errors were detected in 258 patients (6.9% of admissions). Thirty-four deaths were considered due to adverse events (0.89% of admissions), and in 11 cases mortality was deemed avoidable (0.29% of admissions). The incidence of adverse events remained constant during the study period, but errors decreased from 11.1% to 4.5% (P = 0.005). CONCLUSIONS: This is the first attempt to determine the prevalence of errors in surgery. Introducing systematic programs for recording adverse events can reduce error rates and promote a culture of patient safety in a General Surgery Department.

Long-term follow-up of local rectal cancer surgery by transanal endoscopic microsurgery.

BACKGROUND: In 1997 we launched a prospective program of transanal endoscopic microsurgery (TEM) for the treatment of rectal cancer. METHODS: Suitability for TEM was based on endorectal ultrasound results, classified as follows: (I) benign tumors; (II) adenocarcinomas uT0 and uT1 with uN0; (III) adenocarcinomas uT2- uN0, low histological grade with intention to cure; and (IV) advanced stage adenocarcinomas with palliative care RESULTS: Transanal endoscopic microsurgery was performed in 218 patients: 122 adenomas, and 96 adenocarcinomas: group II-72, group III-19, and group IV-5. Follow-up was >24 months (median 59 months) in 61 patients. Nine were lost to follow-up, and so 52 patients were studied: group II-38, group III-11, and group IV-3. The Kaplan-Meier probability of nonrecurrence of adenocarcinoma by group was 93% in tumors in situ (Tis) and T1; and 77.8% in T2. The Kaplan-Meier probability of survival by group was 100% in Tis and T1 and 82% in T2. CONCLUSIONS: Rates of recurrence and long-term survival in Tis and T1 adenocarcinomas treated with TEM are similar to those in previously published reports using conventional surgery. Further studies are required in T2 adenocarcinomas to determine a definitive strategy.