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.

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.

[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.

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.

[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.

[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.