Data quality validation of the Spanish Incisional Hernia Surgery Registry (EVEREG): pilot study.

PURPOSE: The Spanish Incisional Hernia Surgery Registry (EVEREG) was promoted by the Abdominal Wall Section of the Spanish Association of Surgeons, starting data collection in July 2012 and currently has more than 14,000 cases. The objective of this study was to validate the data collected through a pilot audit process. METHODS: A sample of hospitals participating in the EVEREG registry since the beginning was selected. Patients registered in these centers in the 2012-2020 period were included. A stratified random sampling was carried out, with the inclusion of 10% of registered cases per center with a minimum of 20 cases per center. At each participating center, two researchers not belonging to the center undergoing the audit checked (on site or telematically) the concordance between the data in the registry and the data contained in the case history of each patient. RESULTS: 330 patients have been analyzed, out of a total of 2673 registered, in 9 participating centers. The average accuracy has been 95.7%. Incorrect data 1.5% and missing data 2.3% CONCLUSION: The group of pilot hospitals from this EVERG incisional hernia surgery registry shows a very high precision of 95.7%. The confirmation of these findings in all the centers participating in the registry will make it possible to guarantee the quality of the studies made and their comparability with other similar national registries. TRIAL REGISTRATION: nnTrial registration number: ClinicalTrials.gov ID:NCT03899012.

Analysis of outcomes of emergency general and gastrointestinal surgery during the COVID-19 pandemic.

BACKGROUND: Few surgical studies have provided adjusted comparative postoperative outcome data among contemporary patients with and without COVID-19 infection and patients treated before the pandemic. The aim of this study was to determine the impact of performing emergency surgery in patients with concomitant COVID-19 infection. METHODS: Patients who underwent emergency general and gastrointestinal surgery from March to June 2020, and from March to June 2019 in 25 Spanish hospitals were included in a retrospective study (COVID-CIR). The main outcome was 30-day mortality. Secondary outcomes included postoperative complications and failure to rescue (mortality among patients who developed complications). Propensity score-matched comparisons were performed between patients who were positive and those who were negative for COVID-19; and between COVID-19-negative cohorts before and during the pandemic. RESULTS: Some 5307 patients were included in the study (183 COVID-19-positive and 2132 COVID-19-negative during pandemic; 2992 treated before pandemic). During the pandemic, patients with COVID-19 infection had greater 30-day mortality than those without (12.6 versus 4.6 per cent), but this difference was not statistically significant after propensity score matching (odds ratio (OR) 1.58, 95 per cent c.i. 0.88 to 2.74). Those positive for COVID-19 had more complications (41.5 versus 23.9 per cent; OR 1.61, 1.11 to 2.33) and a higher likelihood of failure to rescue (30.3 versus 19.3 per cent; OR 1.10, 0.57 to 2.12). Patients who were negative for COVID-19 during the pandemic had similar rates of 30-day mortality (4.6 versus 3.2 per cent; OR 1.35, 0.98 to 1.86) and complications (23.9 versus 25.2 per cent; OR 0.89, 0.77 to 1.02), but a greater likelihood of failure to rescue (19.3 versus 12.9 per cent; OR 1.56, 95 per cent 1.10 to 2.19) than prepandemic controls. CONCLUSION: Patients with COVID-19 infection undergoing emergency general and gastrointestinal surgery had worse postoperative outcomes than contemporary patients without COVID-19. COVID-19-negative patients operated on during the COVID-19 pandemic had a likelihood of greater failure-to-rescue than prepandemic controls.

Evaluation of data quality in the Spanish EURECCA Esophagogastric Cancer Registry.

BACKGROUND: Although the number of nationwide clinical registries in upper gastrointestinal cancer is increasing, few of them perform regular clinical audits. The Spanish EURECCA Esophagogastric Cancer Registry (SEEGCR) was launched in 2013. The aim of this study was to assess the reliability of the data in terms of completeness and accuracy. METHODS: Patients who were registered (2014-2017) in the online SEEGCR and underwent esophagectomy or gastrectomy with curative intent were selected for auditing. Independent teams of surgeons visited each center between July 2018 and December 2019 and checked the reliability of data entered into the registry. Completeness was established by comparing the cases reported in the registry with those provided by the Medical Documentation Service of each center. Twenty percent of randomly selected cases per hospital were checked during on-site visits for testing the accuracy of data (27 items per patient file). Correlation between the quality of the data and the hospital volume was also assessed. RESULTS: Some 1839 patients from 19 centers were included in the registry. The mean completeness rate in the whole series was 97.8% (range 82.8-100%). For the accuracy, 462 (25.1%) cases were checked. Out of 12,312 items, 10,905 were available for verification, resulting in a perfect agreement of 95% (87.1-98.7%). There were 509 (4.7%) incorrect and 35 (0.3%) missing entries. No correlation between hospital volume and the rate of completeness and accuracy was observed. CONCLUSIONS: Our results indicate that the SEEGCR contains reliable data.

Long-term results of a prospective randomized trial of midline laparotomy closure with onlay mesh.

PURPOSE: Incisional hernia (IH) continues to be one of the most common complications of laparotomy. The short-term protective effect of the use of mesh has been demonstrated in several studies. At present, there is little evidence on the long-term results of the prophylactic use of mesh. The aim of the present study is to analyze the long-term prevention of IH 5 years after a midline laparotomy during elective surgery. METHODS: A prospective study was performed including all of the 160 patients that had been previously included in the prospective, randomized, controlled trial performed between May 2009 and November 2012. The protocol and results at 1 year have been previously published in 2014. The patients in group A (mesh) were fitted with a polypropylene mesh to reinforce the standard abdominal wall closure. The patients in group B (non-mesh) underwent a standard abdominal wall closure and were not fitted with the mesh. All patients were followed for 5 years or until the diagnosis of incisional hernia was made, further surgery was performed, or the patient died. Cases lost to follow-up were also registered. RESULTS: Five years after surgery, in group A (mesh) we have found 4/80 (5.1%) incisional hernias, while in group B (no mesh) 37/80 patients were diagnosed with an incisional hernia (46.8%). The Kaplan-Meier survival curves for these results show statistically significant differences (p > 0.001). CONCLUSION: The protective effect of the use of an onlay mesh in abdominal wall closure is significantly maintained in the long-term, up to 5 years after surgery. International Standard Randomized Controlled Trial number: ISRCTN98336745.

Comparative study of open abdomen treatment: ABThera™ vs. abdominal dressing™.

INTRODUCTION: Negative pressure therapy (NPT) is a widely recognised procedure for the temporary closure of open abdominal wounds. In this study, we compare two NPT products, the V.A.C.® abdominal dressing (AD) system and the new ABThera™ (ABT) system, in terms of the primary closure rates achieved, types of closure, and the associated morbidity. METHODS: We employed a retrospective comparative study of open-abdomen patients treated with NPT using either AD or ABT. The indications for treatment were damage control surgery, abdominal compartment syndrome, or severe abdominal sepsis. RESULTS: The group of patients treated with ABT showed a higher percentage of primary closures (41 vs. 11%) and required fewer days of NPT (17 vs. 26 days) than the AD group. Differences were statistically significant. In addition, only 4% of patients in the ABT group exhibited enteroatmospheric fistulae, compared to 17% in the AD group. CONCLUSIONS: Compared to the AD system, ABT can achieve faster primary closure after open abdomen treatment with only minor complications.

Quality of life in patients operated on for digestive neoplasia: a prospective study.

AIM: The aim of this study was to evaluate the quality of life in patients having surgery for a digestive neoplasm and to monitor how the patient's perception evolves during the first 6 months after surgery. METHOD: A prospective study was carried out on the pre and postoperative quality of life of patients undergoing surgery for a digestive system neoplasm between May 2009 and December 2010. Patients were asked to complete the Short Form (36) Health Survey questionnaire (SF-36; spanish version 1.4). RESULTS: The study included 80 patients. At 1 month after surgery there was a statistically significant improvement in some domains of the SF-36. At 6 months, a statistically significant improvement was seen in physical functioning, social functioning, mental health and in the two physical and mental domains. We also found statistically significant differences, with women having a worse quality of life. CONCLUSION: Comparison of quality of life before and 6 months after surgical intervention showed improvement in both the psychological and the physical elements. This can be attributed to the fact that the patients have had time to recover from the surgery.

Tratamiento del sinus pilonidal en cirugía sin ingreso / Treatment of pilonidal sinus in ambulatory surgery

OBJETIVO: Desde el inicio de nuestra actividad de Cirugía Sin Ingreso hemos tratado lapatología del sinus pilonidal. En el presente trabajo analizamos los resultados obtenidos y las técnicas empleadas para ello. MATERIAL Y MÉTODOS: Desde enero de1998 a enero 2003 hemos realizado Cirugía Sin Ingreso en nuestro Servicio de Cirugía General y del Aparato Digestivo y desde entonces hemos intervenido a 320 pacientes afectos de sinus pilonidal. La técnica empleada hasta junio de 1998fue la exéresis y cierre primario de la herida, aplicada a 31 pacientes. A partir de julio de 1998 hasta la actualidad, a los 289 pacientes restantes hemos realizado la exéresis en bloque y cierre por segunda intención. Se han controlado las complicaciones aparecidas. RESULTADOS: La técnica de cierre primario de la herida ha cursado con un 71% de seromas postoperatorios que requirieron drenaje y también1 herida infectada (3.2%) que precisó ingreso demorado. Con el cierre por segunda intención se han realizado 4 ingresos inmediatos(1,3%) debidos a una herida quirúrgica más amplia de la prevista. En urgencias se ha atendido a 3 pacientes(0.9%) por hemorragia de la herida, resueltas con cura tópica. No se presentaron otras complicaciones CONCLUSIONES: Nosotros iniciamos la actividad con el cierre primario, pero el alto número de seromas aparecidos que precisaron control y desbridamiento nos indujo al cambio a la técnica con cierre por segunda intención que ha permitido obtener hasta la actualidad unas cifras de complicaciones comparables a las aparecidas en la bibliografía consultada, y el tiempo de baja laboral no es mucho mayor al resto de técnicas descritas (AU)

INTRODUCTION: Since we started our activity in ambulatory surgery we have operated the pathology of pilonidal disease. In the present study we analyze the results obtained and the technique used for it. MATERIAL AND METHODS: From January1998 to January 2003 we have operated on 320patients with pilonidal sinus. The technique used until June 1998 was excision and primary closure of the wound, applied to 31 patients. From July 1998 to the present time, the excision and second intention. healing technique was performed on the remaining 289 patients The complications which appeared have been controlled. RESULTS: Primary closure of the injury presented a 71% of postoperative seromas that needed drainage and also 1 infected wound (3.2%)which required delayed hospitalization. With the second intention closure, there were 4 immediate hospitalizations (1.3%) due to a wound that was larger than predicted. In the emergency area we attended 3 patients (0.9%) for hemorrhage, which was resolved with simple wound packing. There were no other complications, CONCLUSIONS: We started our activity using the primary closure but the high number of seromas that needed control and drainage induced us to change to the healing by second intention technique. With this technique we have obtained, so far, a number of complications comparable to those discribed in the bibliography consulted, and the length of time off work is nogreater than that described with the remainder of techniques (AU)

[Clinical usefulness of the determination of the lipase/elastase ratio and of the polymorphonuclear elastase in the hospital admission of the patient with acute pancreatitis]. / Utilidad clínica de la determinación del cociente lipasa/elastasa y de la elastasa polimorfonuclear en la admisión hospitalaria del paciente con pancreatitis aguda.

OBJECTIVE: The clinical usefulness of the determination of polymorphonuclear elastase in serum, in patients with acute pancreatitis as a predictive value of severity. MATERIAL AND METHODS: A prospective study was made of 60 patients who at admission in the hospital showed high rates not only of lipase but also of polymorphonuclear elastase. High rates of this enzyme have been statistically related with the severity of pancreatitis. This severity is expressed by multifactorial Glasgow prognostic factors and by Ranson's CT degree. The predictive value in the evolution of the disease has been related to the need for surgery and related to the number of hospitalization days in non-operated patients. All these factors have been analysed taking into account such variables as age, sex, and biliary origin of the acute pancreatitis. RESULTS: Our study shows no statistically significant correlation between high polymorphonuclear (pmn) elastase serum levels in patients with acute pancreatitis (AP) and their evolution (as evaluated by means of clinical signs and CT images). In other words, determination of high pmn elastase serum levels has no predictive value to indicate the degree of severity in AP. Finally, we have found no clinical use in the lipase/ amylase ratio, neither as a predictive value in the evolution of our AP patients nor as a diagnostic tool to aid in the distinction among AP of biliary origin and AP due to other causes. CONCLUSION: The severity of acute pancreatitis must be evaluated according to clinical parameters and CAT scan imaging.