[Boerhaave's syndrome: a review of our experience over the last 16 years]. / Síndrome de Boerhaave: revisión de nuestra experiencia en los últimos 16 años.

OBJECTIVE: Report our experience in the diagnosis and treatment of Boerhaave syndrome by retrospective study from 1997 to 2013. PATIENTS AND METHODS: A retrospective study was conducted covering the time frame of 1997 to 2013. RESULTS: There were a total of 5 men (71%) and 2 women (29%) and the mean age was 54 years (range: 33-80 years). Diagnosis was made through computed tomography scan in 5 cases (71%) and esophagogram in 2 cases (19%). Six patients (86%) had emergency surgery, whereas one case (14%) was managed conservatively. The surgical technique employed was primary suture and repair in 4 patients (67%) and esophageal resection and subsequent cervical esophagostomy in 2 patients (33%). CONCLUSIONS: Boerhaave's syndrome is a clinically rare entity with an elevated mortality rate. Therefore, a high degree of suspicion is necessary for making the diagnosis and providing early treatment that can result in improved outcome.

[Laparoscopic apendicectomy vs open approach for the treatment of acute appendicitis]. / Apendicectomía laparoscópica frente al abordaje abierto para el tratamiento de la apendicitis aguda.

BACKGROUND: There is no international consensus on the approach of choice for performing appendectomy. AIMS: To analyze and compare open and laparoscopic approaches in the surgical treatment of acute appendicitis. MATERIAL AND METHODS: A retrospective study was carried out on patients over 14-years-old operated on for suspected acute appendicitis between January 2007 and December 2009. Variables were: age, sex, body mass index, specialized surgeon or resident in training, progression duration, conversion rate, use of drains, abdominal cavity irrigation, macroscopic appearance of the appendix, onset time of anesthesia, ASA classification, postoperative hospital stay, resumption of intake of liquids, and complications. The patients were divided into two groups: laparoscopic approach (LA) and open approach (OA). RESULTS: A total of 533 patients were enrolled (290 LA and 243 OA). Onset time of anesthesia was 75 min (30-190 min) in LA vs 55 min (20-160 min) in OA (p<0,0001). COMPLICATIONS: intraabdominal abscesses in 17 LA cases vs 13 OA cases (p=0,79); surgical wound alterations in 16 LA cases vs 47 OA cases (p=0,0001); incisional hernias in 2 LA cases (1%) vs 10 OA cases (p=0,008). There were no statistically significant differences in postoperative hospital stay (3 days), resumption of intake of liquids (1 day) or readmission rate (8%). CONCLUSIONS: There are fewer surgical wound alterations and incisional hernias with the laparoscopic approach, but there is higher cost, lengthier surgery duration, and a longer learning curve. Our results cannot provide a clear indication for one approach or the other, and therefore each case must be evaluated on an individual basis.

Impact of the total number of harvested lymph nodes after colon cancer resections on survival in patients without involved lymph node.

BACKGROUND: The total number of harvested lymph nodes has been demonstrated to be of prognostic significance for colon cancer. Differences can occur in the total number of harvested lymph nodes between different specialists (surgeons and pathologists). OBJECTIVE: The aim of this study was to analyse if, in our centre, the number of analysed lymph nodes in patients with colon cancer that are classified as pN0 is also related to survival. MATERIAL AND METHODS: A retrospective study was designed, where 148 patients with colon adenocarcinoma (pN0 of TNM classification) who underwent elective surgery between 1 January 1995 and 31 December 2001, with curative intent were included. Three groups were created according to the number of analysed lymph nodes ( < 7, 7-14, > 14 lymph nodes). For survival analysis the Kaplan-Meier and CUSUM curves methods were used. RESULTS: The total number of analysed lymph nodes was 1,493 (mean 10.1 lymph nodes per patient). The rate of 5-years survival was 63.0% in the group with < 7 lymph nodes; 7-14 lymph nodes: 80.6% and those with > 14 lymph nodes: 91.8% (p < 0.01). Prognostic significance was also present for multivariate analysis. CONCLUSION: In our centre, harvesting a larger number of lymph nodes is related to improved rates of 5-years survival for patients with colon cancer staged as pN0. It seems reasonable to recommend obtaining as many lymph nodes as possible, and not to establish a minimum number of lymph nodes to be harvested.

Validation of the Italian version of the WHO-Well-Being Questionnaire (WHO-WBQ) and the WHO-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ).

AIM: To validate the Italian version of the World Health Organization (WHO)-Well-Being Questionnaire (WBQ) and the WHO-Diabetes Treatment Satisfaction Questionnaire (DTSQ) in Type 1 and Type 2 diabetic patients. METHODS: The cultural adaptation of the questionnaires was performed by using standard forward/backward techniques. Internal consistency reliability was estimated by Cronbach's alpha coefficient. Construct validity was evaluated using the Short Form-36 (SF-36) Health Status Questionnaire. Finally, the discriminative properties of the questionnaires were evaluated relative to the patients' characteristics. The questionnaires were administered to a random sample of patients identified in twelve outpatient diabetes clinics. RESULTS: Overall, 412 subjects were recruited, of whom 96 (23%) with Type 1 diabetes. Item-scale correlations were >0.40 for all the items. Cronbach's alpha coefficient was 0.86 for the WHO-DTSQ and ranged between 0.79 and 0.91 for the WHO-WBQ. High correlations were found between WHO-WBQ scales and the mental dimensions of the Short Form-36 (SF-36) questionnaire, but not between WHO-DTSQ and SF-36 scores. Women, obese subjects, those with longer diabetes duration and multiple complications showed a worse quality of life in all of the four areas of the WHO-WBQ. In Type 2 diabetic subjects, SF-36 scores, but not WHO-WBQ scores, were able to discriminate the population according to the treatment modalities. Lower levels of treatment satisfaction were related to female gender, longer diabetes duration, insulin treatment, presence of diabetes complications and HbA1c levels >7.0%. The flexibility of the treatement was perceived as a major problem even among patients treated with oral agents. CONCLUSIONS: The WHO-DTSQ can be considered as a valuable instrument to be used internationally for the description of diabetes treatment satisfaction. The WHO-WBQ also shows adequate psychometric properties, but additional data are needed to clarify whether it is more sensitive than SF-36, the most widely used generic instrument.

Assessment of the QoL in Italian menopausal women: comparison between HRT users and non-users.

OBJECTIVES: The aim of this cross-sectional study was to describe QoL in a large sample of women attending menopause centres and compare untreated postmenopausal women and matched HRT users by employing the Women's Health Questionnaire (WHQ) and two generic instruments, the SF-36 and the EQ-5D. METHODS: Overall, 2906 women were recruited by 64 menopause centres throughout Italy, of whom 2160 filled in the questionnaire (1093 on HRT and 1067 not on HRT; response rate: 74%). RESULTS: HRT users tended to be younger, healthier and with shorter menopause duration as opposed to non users, while no major socio-economic differences were present. At multivariate analysis, the presence of chronic diseases, low socio-economic status and living in Southern Italy represented the most important predictors of poor QoL. Furthermore, HRT users showed a lower probability of reporting problems in usual activities and pain/discomfort (EQ-5D), role limitations due to emotional problems (SF-36) and anxiety/fears (WHQ). HRT users also showed highly significant better outcomes in those areas that are more directly attributable to hormonal changes of mid age, namely vasomotor symptoms and sexual problems. CONCLUSIONS: Although QoL is mainly influenced by socio-economic and cultural factors, HRT has the potential for improving not only symptoms, but also more general aspects of physical and psychological well-being of symptomatic postmenopausal women.

Validation of Italian version of the Women's Health Questionnaire: assessment of quality of life of women from the general population and those attending menopause centers.

OBJECTIVES: The Women's Health Questionnaire has been developed and validated in Anglo-Saxon and Swedish populations. The purpose of this study was to evaluate the Italian version of the questionnaire to determine whether cross-cultural differences exist in the perception of quality of life, and to use it to compare the quality of life in women attending menopause centers with that of women in the general population. METHODS: An Italian version of the Women's Health Questionnaire (WHQ) was produced, using the forward-backward translation method to ensure conceptual equivalence, and approved by the originator. Women were recruited by random selection from the general population and from menopause centers, those taking hormone replacement therapy being ineligible. The questionnaire was completed anonymously at home and mailed to the co-ordinating center. Psychometric evaluation included tests of item convergent and discriminant validity, internal-consistency reliability, test-retest reliability, construct validity and the discriminative properties of the questionnaire. RESULTS: The completeness of the data was good, with missing-value rates consistently low for most items. Item-scale correlations, used to evaluate internal consistency, were also good and the scaling success rate, used to measure item discriminant validity, was high for all scales. Scale scores were reliable for seven out of nine scales and test-retest reliability was excellent. There were few significant differences between the two populations of women in most of the WHQ areas. A comparison of Italian data with published data on English women showed great similarity. CONCLUSION: The Italian version of the WHO is valid and reproducible. The subjective perception of the menopause and its related problems is similar in geographically and culturally different populations.

Effect of insulin and sulfonylurea therapy, at the same level of blood glucose control, on low density lipoprotein subfractions in type 2 diabetic patients.

The aim of this study was to evaluate the effect of sc insulin (INS) compared with sulfonylurea (SUL) therapy, at the same level of blood glucose control, on the low density lipoprotein (LDL) subfraction profile in normolipidemic type 2 diabetic patients. Nine normolipidemic type 2 diabetic men (age, 56+/-3 yr; body mass index, 26.5+/-0.9 kg/m2; mean +/- SEM), after a 3-week wash-out period, were assigned to INS or SUL for 2 months in a randomized cross-over design. Doses were adjusted only during the first month and then were kept constant. At the end of the treatments, hemoglobin A1c, plasma lipids, LDL, and very low density lipoprotein (VLDL) subfraction profiles and plasma postheparin lipoprotein lipase and hepatic lipase (HL) activities were evaluated. Despite glucose control was similar at the end of both periods (hemoglobin A1c, 7.4+/-0.3% vs. 7.0+/-0.2%, INS vs. SUL), INS compared with SUL significantly reduced plasma triglyceride (0.9+/-0.1 vs. 1.1+/-0.1 mmol/L; P < 0.05). Although INS did not affect the LDL concentration, it induced a decrease in both the amount (59.0 = 9.8 vs. 76.1+/-16.8 mg/dL; P = NS) and the proportion (31.2+/-3.0% vs. 38.3+/-3.8%; P < 0.03) of small LDL. Moreover, the decrease in small LDL was positively related to the reduction of large VLDL (r = 0.67; P < 0.04) and HL (r = 0.69, P < 0.05) induced by insulin therapy. In conclusion, sc insulin therapy, independently of glucose control and even in the presence of quite low plasma triglyceride levels, is able to reduce small LDL particles in type 2 diabetic patients. This change is related to decreases in both HL activity and large VLDL particles.

Insulin and sulfonylurea therapy in NIDDM patients. Are the effects on lipoprotein metabolism different even with similar blood glucose control?

This study evaluates the effects of insulin versus glibenclamide on lipoprotein metabolism at comparable levels of blood glucose control, in particular on the concentration and distribution of VLDL subfractions and lipolytic enzyme activities in nine NIDDM men (aged 56 +/- 3 years, BMI 26.5 +/- 0.9 kg/m2) (means +/- SE) participating in a crossover study. After a 3-week washout period, patients were randomly assigned to 2-month treatment periods (insulin or glibenclamide); thereafter, each patient crossed to the other treatment. At the end of each period, mean daily blood glucose (MDBG), HbA1e, plasma lipids, lipoproteins (VLDL, LDL, HDL), lipoprotein subfractions (VLDL1, 2, 3; HDL2, HDL3), and post-heparin lipase activities (lipoprotein lipase [LPL], hepatic lipase [HL]) were evaluated. Although glucose control was similar at the end of both periods (MDBG 8.3 +/- 0.3 vs. 7.9 +/- 0.3 mmol/l; HbA1c 7.4 +/- 0.3 vs. 7.0 +/- 0.2%, insulin versus glibenclamide), insulin compared with glibenclamide induced a significant reduction in plasma triglycerides (0.9 +/- 0.1 vs. 1.1 +/- 0.1 mmol/l, P < 0.05), VLDL triglycerides (50.1 +/- 12.2 vs. 63.6 +/- 12.3 mg/dl, P < 0.02), VLDL1 lipid concentration (24.9 +/- 7.5 vs. 39.9 +/- 9.5 mg/dl, P < 0.006), and increased HDL2 cholesterol (25.2 +/- 1.6 vs. 20.3 +/- 1.3 mg/dl, P < 0.03). In terms of VLDL percentage subfraction distribution, with insulin, there was a decrease in the larger subfractions (VLDL1 26.5 +/- 3.0 vs. 37.8 +/- 3.4%, P < 0.02) and an increase in the smallest (VLDL3 47.3 +/- 3.8 vs. 37.3 +/- 3.3%, P < 0.05). Moreover, HL activity was significantly lower after insulin than after glibenclamide (HL 247.2 +/- 22.3 vs. 263.5 +/- 22.6 mU/ml, P < 0.05). In conclusion, compared with glibenclamide, insulin treatment (independent of variations in glucose control) is able to decrease significantly plasma triglycerides, to increase HDL2 cholesterol, and to reduce only the concentration of the larger VLDL subfractions, with a consequent redistribution of their profile.

Safety, efficacy, acceptability of a pre-filled insulin pen in diabetic patients over 60 years old.

The aim of the study was to evaluate safety, efficacy and acceptability of a pre-filled insulin pen device (NovoLet) in diabetic patients over 60 years old already treated with insulin administered with conventional syringes. After a run-in period of 2 weeks, 60 patients participated in a randomized cross-over study with two 6-week treatment periods using the insulin pen or conventional syringes. Insulin regimens did not change during the study. Hypoglycaemic episodes did not differ significantly between both kinds of treatment and no severe hypoglycaemia was registered. HbAlc (%) was (mean +/- S.D.) 7.7 +/- 1.2 and 7.9 +/- 1.1 during pen and syringe treatment, respectively. Blood glucose profiles were similar during both treatment modalities except for pre-lunch blood glucose values (mmol/l) lower during pen treatment (8.7 +/- 2.9 vs. 9.2 +/- 2.7, P < 0.01). The insulin dose (U/day) was 31.9 +/- 8.9 (pen) and 32.3 +/- 9 (syringe). 54 patients found the functioning of the insulin pen easy to understand and preferred it for future treatment because the conditions of insulin administration are faster and easier than with conventional syringes. We concluded that the pre-filled insulin pen is safe, efficacious and is highly accepted in over 60 years old diabetic patients.

Reduction in insulin antibodies 42 months after transfer from porcine to human monocomponent insulins.

The present study was planned to evaluate if a longterm follow-up would show any modification of insulin antibodies in IDDs transferred from porcine to human monocomponent insulins. Nineteen IDDs, treated for more than one year with porcine monocomponent insulins, were transferred to the equivalent formulations of human insulin (Actrapid HM, Monotard HM); insulin antibodies, metabolic control, insulin dose, adverse drug reactions were evaluated during a 42-month follow-up. A reduction of IgG insulin antibodies was observed after 22 months of the follow-up and became significant (2p less than 0.05) at the 42nd month. No significant modification of metabolic control, insulin requirement, or hypoglycaemic episodes were recorded. No adverse events were reported.

Semisynthetic human insulin: biologic and immunologic activity in newly treated diabetic subjects during a six-month follow-up.

Biologic and immunogenic activities of semisynthetic human monocomponent insulins were examined in insulin-dependent diabetic patients (group 1). Patients treated with porcine monocomponent (group 2) and conventional (group 3) insulins were studied for control purposes. The patients were examined before the beginning of insulin treatment and for a 6-mo follow-up period. The data collected during the study show that insulin antibody levels were significantly lower in group 1 than in groups 2 and 3. Furthermore, the prevalence of immune complexes assays with the C1q solid phase technique failed to reveal any differences between the three groups. When the conglutinin binding test was used, the prevalence of immune complexes showed a slight but not significant reduction in group 1 and a significant increase in group 3. The metabolic control was similar in the three groups during follow-up and the insulin requirement was lower, but not significantly, in group 1 than in groups 2 and 3. These data suggest that with human monocomponent insulins equivalent glycemic control may be achieved at similar doses than those required with porcine monocomponent insulins. Furthermore, human insulin is the least immunogenic of the present available insulins.