Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.

OBJECTIVE: To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity. METHODS: This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test. RESULTS: At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001). CONCLUSIONS AND RELEVANCE: This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.

Dissemination of hepatocellular carcinoma in subcutaeous tissue after fine needle aspiration cytology (FNAC).

The hepatocellular carcinoma (HCC) is the fifth most frequent tumor in the world, and the third cause of death related to cancer. Histological samples obtained from diseased liver likely to have HCC are currently prescribed in selected patients in whose imaging studies and tumor markers are not sufficient for the diagnosis. In recent years, a risk of tumoral seeding along needle tract of FNAC to obtain histological samples has been reported. We present a case of tumor implantation of HCC cells in the needle tract, a year and four months after a percutaneous fine needle aspiration cytology (FNAC).

Effect of long-term individual cognitive stimulation intervention for people with mild neurocognitive disorder. / Efecto de la intervención de estimulación cognitiva individual de larga duración para personas con trastorno neurocognitivo leve.

INTRODUCTION: Cognitive stimulation may be beneficial in slowing the progression of mild neurocognitive disorder (NCD), but the results of existing research are inconsistent. Furthermore, there are no long-term interventions nor individual (one-on-one) interventions applied by professionals. Objetive. The aim of this study was to assess the efficacy of a long-term individual cognitive stimulation intervention on people with mild NCD. PATIENTS AND METHODS: A pre-post test design with a non-equivalent control group was conducted. A total of 82 participants with mild NCD were assigned to a cognitive stimulation intervention group or to a control group. The intervention consisted of 88 individual format sessions of approximately 45 minutes, twice per week. Independent evaluators assessed cognition, depressive symptomatology and autonomy level in activities of daily living at pre-intervention, intra-intervention (6 months) and post-intervention (12 months). RESULTS: At intra- and post-intervention, significant improvement on cognition and depressive symptomatology in the intervention group compared to the control group were found. Younger participants and those with better cognitive function and status in pre-intervention achieved better results. Adherence to the intervention was high. CONCLUSIONS: Results suggest the efficacy of long-term individual cognitive intervention in people with mild NCD, which could delay the progression towards a major NCD.

TITLE: Efecto de la intervención de estimulación cognitiva individual de larga duración para personas con trastorno neurocognitivo leve.Introducción. La estimulación cognitiva puede ser beneficiosa para ralentizar la progresión del trastorno neurocognitivo (TNC) leve, pero los resultados de las investigaciones existentes son inconsistentes. Además, no existen intervenciones a largo plazo ni intervenciones individuales (uno a uno) aplicadas por profesionales. Objetivo. El objetivo de este estudio fue evaluar la eficacia de una intervención de estimulación cognitiva individual de larga duración para personas con TNC leve. Pacientes y métodos. Se llevó a cabo un diseño pretest-postest con un grupo control no equivalente. Un total de 82 participantes con TNC leve fueron asignados a un grupo de intervención de estimulación cognitiva o a un grupo control. La intervención consistió en 88 sesiones de formato individual de aproximadamente 45 minutos, dos veces por semana. Evaluadores independientes evaluaron la cognición, la sintomatología depresiva y el nivel de autonomía en las actividades de la vida diaria en la preintervención (línea base), la intraintervención (seis meses) y la postintervención (12 meses). Resultados. En la intra- y la postintervención, se encontró una mejora significativa en la cognición y la sintomatología depresiva en el grupo de intervención en comparación con el grupo control. Los participantes más jóvenes y los que tenían una mejor función y estado cognitivo en la preintervención obtuvieron mejores resultados. La adhesión a la intervención fue alta. Conclusiones. Los resultados sugieren la eficacia de una intervención cognitiva individual de larga duración para personas con TNC leve, que podría retrasar la progresión hacia un TNC mayor.

[Long-term individual cognitive stimulation program in patients with mild neurocognitive disorder: a pilot study]. / Programa de estimulacion cognitiva individual de larga duracion para personas con trastorno neurocognitivo leve: estudio piloto.

INTRODUCTION: There is evidence to suggest that cognitive stimulation produces cognitive benefits in people with mild neurocognitive disorder. However, the effect has been previously demonstrated to be minimal to moderate and the effect of long-term individual interventions, namely on specific cognitive domains, is unknown. AIM: To assess the efficacy, feasibility and acceptability of a long-term individual cognitive stimulation intervention for patients with mild neurocognitive disorder. PATIENTS AND METHODS: Patients (n = 30) with mild neurocognitive disorder were assigned to a cognitive stimulation intervention group (n = 15) or to a control group (n = 15). The intervention consisted of 88 individual sessions, approximately 45 minutes long, with two sessions per week. External evaluators assessed the level of alteration in cognitive performance, depressive symptoms and the level of independence in the performance of basic activities of daily living. RESULTS: After the intervention, a significant improvement was found in the intervention group compared to the control group in overall cognitive performance (d = 0.83), specifically in the language domain (d until 1.50). There were also lower depressive symptoms in the intervention group compared to the control group (d = 0.93). Only 6.7% of the participants dropped out the study, with participants attending a mean of 83 ± 12.1 sessions. CONCLUSIONS: The results support the efficacy, feasibility and acceptability of the intervention for mild neurocognitive disorder and justify a randomized controlled trial of the program with a larger sample.

TITLE: Programa de estimulacion cognitiva individual de larga duracion para personas con trastorno neurocognitivo leve: estudio piloto.Introduccion. Existen evidencias que sugieren que la estimulacion cognitiva produce beneficios cognitivos en personas con trastorno neurocognitivo leve. Sin embargo, el tamaño del efecto encontrado es de pequeño a moderado, y se desconoce el efecto de las intervenciones individuales de larga duracion y, mas concretamente, sobre dominios cognitivos especificos. Objetivo. Evaluar la eficacia, viabilidad y aceptabilidad de una intervencion de estimulacion cognitiva individual de larga duracion para personas con trastorno neurocognitivo leve. Pacientes y metodos. Un total de 30 personas con trastorno neurocognitivo leve fueron asignadas a un grupo de intervencion de estimulacion cognitiva (n = 15) o a un grupo control (n = 15). La intervencion consistio en 88 sesiones individuales de unos 45 minutos, con una periodicidad de dos veces por semana. Evaluadores independientes valoraron el nivel de rendimiento cognitivo, los sintomas depresivos y el nivel de autonomia en la realizacion de actividades basicas de la vida diaria. Resultados. Tras la intervencion, se encontro una mejoria significativa en el grupo de intervencion en comparacion con el grupo control en el rendimiento cognitivo global (d = 0,83), concretamente en el dominio del lenguaje (d hasta 1,50), y una menor sintomatologia depresiva en el grupo de intervencion en comparacion con el control (d = 0,93). Solo un 6,7% de los participantes abandono el estudio, asistiendo a un promedio de 83 ± 12,1 sesiones. Conclusiones. Los resultados apoyan la eficacia, viabilidad y aceptabilidad de la intervencion, y justifican la realizacion de un ensayo controlado aleatorizado aplicado a una muestra mayor.

Umbilical hernia repair with composite prosthesis: a single-centre experience.

PURPOSE: Since 2004, composite prosthesis repair is the preferred procedure for umbilical hernia repair in our centre, although long-term results of this technique are lacking. The aim of this study was to analyze the long-term results of a cohort of patients who underwent umbilical hernia repair with this procedure. METHODS: A retrospective cohort study of patients who underwent umbilical hernia repair with composite prosthesis was conducted. Data were obtained from electronic medical records. Univariate and multivariate analyses were performed to analyze the factors associated with postoperative complications and hernia recurrence. RESULTS: Between March 2004 and December 2015, 2135 patients underwent umbilical hernia repair and composite prosthesis (Ventralex or Ventralex ST®) was used in 1538 patients. 179 patients were lost during the follow-up. Finally, 1359 patients were included in the study. The prosthesis was placed in the preperitoneal space in 93.4% of the patients. 86.3% of the patients underwent same-day surgery. Only 2.1% of the patients developed a complication during the follow-up, and 1.8% of the patients required a new surgery. After a mean follow-up of 4.1 years, hernia recurrence rate was 3.9%. Multivariate analysis showed that hernia recurrence was associated with female gender, recurrent hernia, and postoperative complication. Postoperative complications were related to follow-up time and smoking patients. CONCLUSIONS: Long-term results after umbilical hernia repair with composite prosthesis are satisfactory, with a low percentage of complications and recurrences.

Incidence of new-onset benign anal disorders after bariatric surgery.

New-onset benign anal disorders (NBADs) represent a potential complication following bariatric surgery, although their incidence in this population is not well studied. The preoperative characteristics, weight loss, bowel habits and NBADs data of 196 patients with bariatric surgery were collected by telephone interviews and medical records review and evaluated retrospectively. Ninety-nine patients had undergone gastric bypass (GBP) and 97 had a modified biliopancreatic diversion (MBPD). Fifty-nine patients were excluded. The mean follow-up of the remaining 137 patients was 87.8 months, and 51 of them (37.2%) developed NBADs. Haemorrhoids were the most common diagnosis and 27.5% of the patients that developed NBADs were treated surgically. Patients who developed NBADs had a longer follow-up time (92.5 vs. 85.1 months, P = 0.003), and those with an abnormal bowel habit (diarrhoea or constipation) had a higher percentage of NBADs (54.5 vs. 28.3%, P = 0.003). NBADs were more frequent after MBPD (52.9%) than after GBP (21.7%) (P < 0.001). Multivariate analysis found that only an abnormal bowel habit was associated with NBADs, with an odds ratio of 3.2 (95% CI: 1.5-6.9, P = 0.003). As NBADs are a common complication after bariatric surgery, further studies should be performed to find the reasons for these complications.

Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.

BACKGROUND: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. METHODS: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed. RESULTS: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months. CONCLUSION: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01448785.

Clinical relevance of MMP-9, MMP-2, TIMP-1 and TIMP-2 in colorectal cancer.

The main aim of this study was to evaluate the clinical relevance of Gelatinases in colorectal cancer (CRC). Ninety-five CRCs and their paired normal tissues were investigated to detect total levels of MMP-9, MMP-2, and the tissue inhibitors TIMP-1 and TIMP-2. Also, pro-MMP and MMP activity, and potential associations with clinical parameters were estimated. MMP-9, MMP-2 and TIMP-1 levels were greater in CRCs than in normal tissues, differences being significant for MMP-9 and TIMP-1. However, TIMP-2 showed significantly lower levels in tumour samples. Moreover, significant differences in the state of activation between gelatinases were found. TIMP-1 low levels were significantly associated with poor clinical outcome of patients. According to these data, different roles have to be attributed to MMP-2 and MMP-9 in CRC progression. Moreover, TIMP-1 level evaluation emerges as the main prognostic factor in relation to Gelatinases A and B activity in CRC.

Overexpression of c-myc and loss of heterozygosity on 2p, 3p, 5q, 17p and 18q in sporadic colorectal carcinoma.

AIM: The aim of the present study is to evaluate the prognostic influence of loss of heterozygosity on 2p, 3p, 5q, 17p and 18q, and c-myc overexpression on surgically treated sporadic colorectal carcinoma. METHODS: Tumor and non-tumor tissue samples from 153 patients were analyzed. Fifty-one percent of patients were male, and mean age in the series was 67 years. Tumors were located in the proximal colon in 37 cases, in the distal bowel in 37, and in the rectum in 79 patients. c-myc overexpression was studied by means of Northern blot analysis, and loss of heterozygosity through microsatellite analysis. RESULTS: c-myc overexpression was detected in 25% of cases, and loss of heterozygosity in at least one of the studied regions in 48%. There was no association between clinical and pathologic features, and genetic alterations. The disease-free interval was significantly shorter for patients with both genetic alterations; the presence of both events was an independent prognostic factor for poor outcome in the multivariate analysis (RR: 4.34, p < 0.0001). CONCLUSIONS: The presence of both loss of heterozygosity and overexpression of the c-myc oncogene separates a subset of colorectal carcinoma patients who have a shorter disease-free interval after curative-intent surgery.

Influência da adiposidade durante a gestação de éguas da raça Crioula sobre o acúmulo de gordura em seus potros / Influence of adiposity during pregnancy of Crioulo mares on the fat accumulation in their foals

Este trabalho investigou a influência da adiposidade em éguas Crioulas gestantes sobre o peso e o acúmulo de gordura de seus potros do nascimento aos quatro meses de vida. Foram avaliadas 28 éguas Crioulas no terço final de gestação, divididas em dois grupos (normais e obesas) quanto ao peso, à circunferência de pescoço, à altura da crista do pescoço e à gordura subcutânea na base da cauda, bem como quanto à relação dessas medidas com as de seus potros, do parto aos 120 dias de idade. Os filhos de éguas obesas apresentaram maior deposição de gordura na base da cauda, no segundo mês (P<0,05), e na crista do pescoço (P=0,0022), no quarto mês de idade. Houve correlação positiva da altura da crista do pescoço da égua com o peso dos potros ao nascer (P=0,01; r= 0,54) e do peso corporal das éguas com gordura na base da cauda dos potros ao nascimento (P=0,03; r=0,49), além de forte associação entre gordura na base da cauda das éguas obesas com essa medida nos seus potros aos quatro meses (P=0,01; r=0,71). Essa diferença entre os grupos de potros quanto à adiposidade sugere que filhos de éguas obesas são mais propensos a acumular mais gordura já nos primeiros meses de vida.(AU)

This work investigated the influence of adiposity on pregnant Crioulo mares on the weight and fat deposition of their foals from birth to four months of life. Twenty-eight Crioulo mares were evaluated during the final third of gestation, divided into two groups (normal and obese) regarding weight, neck circumference, neck crest height and fat at the tail base, and the relation of these measurements with those of their foals from birth to 120 days old. The obese mares presented higher fat deposition at the tail base in the 2nd month (P< 0.05) and crest of the neck (P= 0.0022) in the 4th month of age. There was positive correlation between height of mare's neck crest and foal weight at birth (P= 0.01, r= 0.54) and body weight of mares between the fat at tail base of foals at birth (P= 0.03, r= 0.49), as well as strong association between fat at the tail base in obese mares with this measurement in their foals at 4 months (P= 0.01, r= 0.71). This difference of adiposity between groups suggests that obese mare's offspring are more likely to accumulate more fat in the first months of life.(AU)

Differential prognosis of replication error phenotype and loss of heterozygosity in sporadic colorectal cancer.

Several distinct genetic alterations have been associated with colorectal tumorigenesis. This study investigated the frequency of microsatellite instability, also known as replication error (RER), and loss of heterozygosity (LOH) at six chromosome regions in sporadic colorectal cancer (CRC). Eighty-six tumour and paired normal mucosa samples were included in the study. A polymerase chain reaction (PCR)-based technique was performed to analyse six (CA)n dinucleotide repeats located near or within regions containing important genes implicated in the complex process of colorectal tumorigenesis (chromosomes 2p, 3p, 5q, 11p, 17p and 18q). Overall, LOH frequency was higher in RER-tumours (25/46, 54.3%) compared with RER+ tumours (9/40, 22.5) (P = 0.04). To investigate prognostic implications, survival analysis was performed for 66 patients. Compared with RER- tumours, patients with RER+ tumours at 2p, 3p, 5q, 11p or 18q were found to have an improved prognosis (overall survival, P = 0.02 and disease-free survival (DFS) P = 0.005) this variable being an independent prognostic factor by multivariate analysis (P = 0.001). Overall survival of patients whose tumours were LOH+ was significantly shorter compared with those without LOH (overall survival, P = 0.008 and DFS, P = 0.01). Thus, tumours displaying RER+ and LOH+ phenotype, as established by microsatellite analysis, show a differential prognosis. These data indicate that this may be a useful tool for the identification of patients at different risks affected by CRC.

p53 exon 7 mutations as a predictor of poor prognosis in patients with colorectal cancer.

We have studied 61 resected colorectal adenocarcinomas in order to investigate p53 mutations as a prognostic factor for this pathology. Mutations in exons 5-9 of the p53 gene were analyzed by the polymerase chain reaction-single strand conformation polymorphism (PCR-SSCP) technique followed by sequencing. Our data indicate that p53 exon 7 mutations were prevalent in the latest stages of colorectal carcinogenesis and patients bearing this alteration had the worst prognosis. Therefore, according to our results, mutations affecting exon 7 of the p53 gene could be considered as a useful marker of biological aggressiveness for colorectal cancer.

Prognostic value of the quantified expression of p185 in non-small cell lung cancer.

BACKGROUND: We sought to assess the relationship between tissue concentration of erb -b-2 or neu oncogene-encoded protein (p185(neu)) with overall survival in patients with non-small cell lung cancer. METHODS: Levels of protein p185(neu) were determined in 102 patients with the diagnosis of non-small cell lung cancer. Concentration of p185(neu) protein was determined by using enzyme immunoassay and evaluated by using several variables. The relative prognostic importance of this marker and its influence on other prognostic factors was evaluated by using the Cox regression model. RESULTS: The mean p185(neu) value in these samples was 250 +/- 200 U/mg (95% confidence interval, 210-290). This distinguished two groups within the tumoral population: those with less than 350 U/mg and those with 350 U/mg or greater (80th percentile). Multivariable analysis established an independent prognostic value for protein p185(neu). Patients with p185(neu) values of the 80th percentile or greater had a risk of death that was 2.11-fold (95% confidence interval, 1.10-4.05) that of patients with values of less than 350 U/mg (P =.03), and increases in the neu oncogene of 100 U/mg increased the probability of death by 17% (P =.02; 95% confidence interval, 1.04-1.31). CONCLUSION: This study shows that the p185(neu) expression is an objective and comparable variable for the assessment of phenotypic aggressivity in non-small cell lung cancer, and in the future, it could be included in daily clinical practice.

Somatostatin in the management of gastrointestinal fistulas. A multicenter trial.

To evaluate the effectiveness of treatment with total parenteral nutrition (TPN) alone (group A) or combined with continuous intravenous infusion of somatostatin (group B) in postoperative gastrointestinal fistulas, a multicenter, controlled and prospective randomized trial was designed. We present the results obtained after the evaluation of 40 cases (group A, n = 20; group B, n = 20). No significant differences among these treatment schedules were observed in the percentage of closure of fistulas (group A, 81.25%; group B, 85%), but patients treated with total parenteral nutrition plus somatostatin had the fistulas close within a significantly shorter period of time. Moreover, this treatment was associated with a significantly lower morbidity. These preliminary results indicate that somatostatin is a useful therapeutic complement in the conservative treatment of patients with gastrointestinal fistulas.

Palliative treatment of esophageal cancer: self-expanding metal stents versus Postlethwait technique.

BACKGROUND/AIMS: The development of new techniques for palliation of esophageal carcinoma with lower morbidity and mortality than surgical procedures. METHODOLOGY: Between 1981 and 1994, 258 patients with esophageal and cardiac cancer were treated in our Department. We selected two groups: Group A, 25 patients underwent a by-pass with an isoperistaltic gastric tubular (Postlethwait technique) and, group B, in 30 patients we placed 35 autoexpandable esophageal stents. We subsequently performed a retrospective study. RESULTS: In group A, dysphagia was not relieved in 6 patients (24%) and we found no complications in 18 patients (72%). The hospitalization period ranged from 18-50 days. Hospital mortality rate was 24% (6 patients). Mean survival was 5.4 months (range: 3-9 months). All patients in group B, except for 2, were relieved of dysphagia. Two patients (6.6%) died in the immediate post-intubation period though none of the deaths were related to technical complications. Hospitalization period ranged from 5-12 days. Mean survival was 6 months (range: 12 days to 9 months). CONCLUSIONS: Currently, surgical by-pass procedures are restricted to the patient with an incurable disease not identified until operation time.

Hydatid liver cyst perforation into the digestive tract.

Complications of liver hydatid disease include those related to the compression of adjacent viscus, to the infection of the cyst's contents or to the perforation of the cyst. Perforations into hollow abdominal organs are rare, and can occur secondary to the infection of the cyst or to a primary pathology of the perforated organ. We report on 2 cases of perforation of a liver cyst into the duodenum, 1 due to the presence of a duodenal ulcer, and 1 secondary to a hydatid abscess. The surgical treatment of the lesions and their complications was, in both cases, successful.

[Surgical treatment of pulmonary aspergilloma]. / Tratamiento quirúrgico del aspergiloma pulmonar.

Pulmonary aspergilloma can now be classified as an opportunistic disease given that Aspergillus tends to colonize preexisting cavities in the lung. Aspergilloma is the usual pleuropulmonary anatomical sign, hemoptysis is the most frequent symptom and a chest film is the simplest diagnostic tool. The advisability of surgery is disputed, particularly in asymptomatic patients and/or those at high surgical risk. We describe 14 patients who underwent surgery in our department, evaluating aspects of their clinical signs, diagnosis, attitude toward treatment and the course of their disease. We believe that for patients with symptomatic pulmonary aspergilloma, the treatment of choice is surgery, preferably lung resection. All patients who do not present contraindications for general surgery can be considered operable.

[Mucoprotein secretion in calculous gallbladder]. / Secrección de mucoproteínas en la vesícula biliar con cálculos.

Secretion of mucoproteins or mucine (MP) have been studied as possible markers in several pathological conditions of the digestive tract, such us colonic polyposis or gastric dysplasia. In the gallbladder (VB) it has been established that form the core of crystalization for the calculi. A study in 100 gallbladders have been made based on the utility of the analysis of the qualitative and quantitative modifications of MP in lithogenesis. It was been determined by histochemical techniques the three main types of MP (neutral, low and high sulphated acid) to evaluate the alterations in the process of lithiasis. Results show a high production of the MP in VB with lithiasis, presenting in 97% a mixed composition of MP (48.9% of 2 types, and 3 types in 46%), without a predominating type in this pathology.