Do salivary bypass tubes lower the incidence of pharyngocutaneous fistula following total laryngectomy? A retrospective analysis of predictive factors using multivariate analysis

Salivary bypass tubes (SBT) are increasingly used to prevent pharyngocutaneous fistula (PCF) following laryngectomy and pharyngolaryngectomy. There is minimal evidence as to their efficacy and literature is limited. The aim of the study was to determine if SBT prevent PCF. The study was a multicentre retrospective case control series (level of evidence 3b). Patients who underwent laryngectomy or pharyngolaryngectomy for cancer or following cancer treatment between 2011 and 2014 were included in the study. The primary outcome was development of a PCF. Other variables recorded were age, sex, prior radiotherapy or chemoradiotherapy, prior tracheostomy, type of procedure, concurrent neck dissection, use of flap reconstruction, use of prophylactic antibiotics, the suture material used for the anastomosis, tumour T stage, histological margins, day one post-operative haemoglobin and whether a salivary bypass tube was used. Univariate and multivariate analysis were performed. A total of 199 patients were included and 24 received salivary bypass tubes. Fistula rates were 8.3% in the SBT group (2/24) and 24.6% in the control group (43/175). This was not statistically significant on univariate (p value 0.115) or multivariate analysis (p value 0.076). In addition, no other co-variables were found to be significant. No group has proven a benefit of salivary bypass tubes on multivariate analysis. The study was limited by a small case group, variations in tube duration and subjects given a tube may have been identified as high risk of fistula. Further prospective studies are warranted prior to recommendation of salivary bypass tubes following laryngectomy

Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes

BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P = 0.98). There were no significant between-group differences in rates of acute pancreatitis (P = 0.07) or pancreatic cancer (P = 0.32). CONCLUSIONS: Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

[Maxillary ameloblastoma: a case report].

Ameloblastoma is a neoplasm of odontogenic origin. Although it is considered a benign lesion it presents some peculiarities including a high local recurrence rate, particularly after conservative surgery, and a high loco-regional invasiveness. The present work describes a case of ameloblastoma of the left maxillary sinus bordering on the homolateral nasal fossa. The male patient was admitted to the E.N.T. Dept II of the University of Turin in May 1998 and underwent left radical maxillectomy. The authors also review the literature on the topic

Intensity and fundamental frequency control in tracheoesophageal voice

Tracheo-oesophageal voice prostheses are currently widely used following total laryngectomy. Data on maximum phonation time and spectrum have been studied by various Authors and are well known. On the contrary, intensity and fundamental frequency control have received little attention. Intensity and fundamental frequency play an important role in the prosodic aspects of speech. Fundamental frequency variations have been studied in tone language speakers, but the ability to voluntarily change intensity and fundamental frequency remain to be fully investigated. Aim of the present study was to analyse the ability of tracheo-oesophageal voice users to change intensity and fundamental frequency. A total of 12 male subjects who underwent total laryngectomy, in whom a tracheo-oesophageal prosthesis had been inserted, were considered. Maximum phonation time was calculated. Each subject was asked to utter an /a/ as loud as possible and an /a/ as soft as possible. Each subject was then asked to utter an /a/ at comfortable pitch and then at an interval of a fifth. Intensity as well as fundamental frequency variations were compared using Wilcoxon signed rank test. Correlation between maximum phonation time and variation in intensity and in fundamental frequency as well as between the two latter variables was calculated using Spearman’s rank correlation coefficient. Mean maximum phonation time was 8 (± 3.8) sec. Mean energy was 50 (± 4.8) dB SPL for soft phonation and 68 (± 4.7) dB SPL for loud phonation. The difference observed was statistically significant (p < 0.02). Mean fundamental frequency values were 106 (± 14) Hz and 135 (± 34) Hz at the interval of a fifth. The difference observed was statistically significant (p < 0.02). Tracheo-oesophageal voice users were able to change intensity and fundamental frequency, but their control was rather poor. Variations in intensity, as well as fundamental frequency, did not show any correlation with maximum phonation time, and were not correlated with each other. In conclusion, the tracheo-oesophageal voice allows small fundamental frequency variations, but their control appears difficult. On the contrary, intensity variations appear larger and control somewhat easier

Differential expression and topography of adhesion molecules in laryngeal and oropharyngeal carcinomas.

This work describes the different patterns of expression of integrins and extracellular matrix proteins in normal and transformed mucosa in laryngeal and oropharyngeal carcinomas. Samples from each tumor group were sectioned and examined by immunohistochemistry using monoclonal antibodies raised against integrin chains (alpha2, alpha3, alpha6, beta1 and beta4) and their ligands (laminins 1 and 5, collagen type IV and two fibronectin isoforms: ED-A and ED-B). Controls were provided by samples of tumor-free laryngeal and oropharyngeal mucosa that had been removed during the surgical procedure. We found that the known distinct topographical pattern of integrins and the continuity of basement membrane components was altered in both groups but that the extent of changes was significantly more marked in oropharyngeal tumors, which are known to be more infiltrating and diffusive and to have a bad prognosis. These molecular patterns of expression can be used as an additional prognostic factor as they suggest a greater biological tumor aggressiveness of oropharyngeal tumors. We suggest that performing immunohistochemical analysis on biopsy samples may help in selecting the correct therapeutic strategy for these tumors and enable more accurate follow-up. The above-mentioned molecules may become part of the diagnostic toolbox of head and neck surgical pathologist

Pharyngocutaneous fistula as a complication of total laryngectomy: review of the literature and analysis of case records.

Pharyngocutaneous fistula is the most common complication of total laryngectomy. The management of this problem increases hospitalization time and delays initiation of postoperative radiotherapy, where indicated. To identify factors predisposing to the development of pharyngocutaneous fistula, we reviewed the postoperative courses of 293 patients who underwent total laryngectomy at our clinic. General factors taken into account were concurrent diseases such as diabetes, liver diseases, or chronic anemia; local factors included radiotherapy before and after surgery, preoperative tracheostomy, type of cervical lymph node removal, and method of pharyngeal closure. We then compared our data with those reported in the literature by other authors. Last, we applied the Fisher exact test to a correlation we found between the higher incidence of fistula in patients with diabetes, liver diseases, or anemia. The local factor that turned out to be statistically most significant for the development of fistula was preoperative radiotherapy

[Post-parotidectomy Frey's syndrome. Treatment with botulinum toxin type A].

The Frey's syndrome, manifest after parotid trauma, is characterized by head and neck hyperemia and abundant sweating of the hyperemic skin in response to gustatory stimuli. The use of the botulin toxin to treat the symptoms in patients with Frey's syndrome has been described in numerous studies. For some time up until now our Center has achieved excellent results using the group A botulin toxin to overcome the hypertonus of the cricopharyngeal muscle in patients who had undergone laryngectomy and were rehabilitated with voice button. We have sought to extend the use of this toxin to Frey's syndrome, a relatively frequent complication of parotidectomy. A total of 86 patients participated in the study: 41 males (47.6%) and 45 females (52.4%) ranging in age from 25 to 77 years (average age 51 years). Of these patients 7 (8.1%) had undergone post-operative radiotherapy. Of the 86 patients studied, 18 referred significant symptoms in terms of abundance and frequency. The syndrome was considered severe if the symptoms were present at each meal and if the patient indicated a significant worsening of his quality of life. Intermittent episodes were indicated by 22 patients. The remaining 46 (43.5%) did not complain of any symptoms. The exact extension of the cervicofacial gustatory sweating was evaluated using the Minor test and the involved region was divided into 1 square centimeters sections. The amount of skin surface involved ranged from 10 to 80 square centimeters. The type A neurotoxin was frozen and was reconstituted with a sterile saline solution at a final concentration of 2.5 UI/0.1 ml. The intracutaneous infiltration was performed without anesthesia, infiltrating 0.1 ml of solution, containing 2.5 UI of toxin into the center of each 1 square centimeters section. Statistical analysis was performed to evaluate the potential relationship between how long the treatment was effective, incidence of recurrence, seriousness of the crises and the following variables: age, sex, histology, cutaneous surface involved, injected dose of botulin toxin and post-operative radiotherapy. In the group of 18 patients with severe symptoms (20.9%) the benefit was immediate in all cases although the recurrence rate was 50%. The Frey's syndrome symptoms disappeared within 7 days of infiltration. In the group of 22 patients with less severe involvement (25.5%), the treatment gave positive, definitive results in 16 patients (72.7%). Those patients whose symptoms persisted were treated a second time with an infiltration of 2.5 UI per square centimeters. We feel that the use of the type A botulin toxin is the most appropriate treatment for the Frey's syndrome. In fact, such treatment offers the following advantages: it is effective within 7 days, has limited side effects, can be applied on an outpatient basis, is inexpensive and is positively considered by the patients