Use of TachoSil® in the entero-colic anastomoses: results of an observational study [TachoSil® nelle anastomosi entero-coliche: Risultato di uno studio osservazionale]

Aim. In the last decade while many comparative studies examined hemostatic topics, adhesives and sealants, few clinical trials were made. We are focusing our attention particularly on TachoSil (R), and studying its efficacy on reducing the frequency of anastomotic leakage, thought to be one of the causes of prolonged periods of patients' hospitalization. Methods We examined 188 patients who underwent colorectal and enteric surgery at our department between January 2010 and March 2013. The efficacy of fibrin glue was evaluated on a cohort of patients at risk of anastomosis leakage. To test the relationship between the application of TachoSil (R) and the type of complications, a multiple logistic regression model was implemented. Fisher exact Test was used to compare the relations between two groups. The Mann-Whitney test was used to account for the days necessary for the follow-up of the patients in the various units participating in the study. Results. From the logistic regression model we can infer that TachoSil (R) is a highly protective factor though not statistically significant (OR=0.78; P>0.05). The results obtained analyzing the average days of patients hospitalization show a statistically significant decrease of such parameter in patients under treatment, especially those who underwent transverse colon resection (P<0.001). Conclusion. The results of this study show that TachoSil is a highly protective factor, but its efficacy is not statistically significant due to the small number of patients treated. It is important to call the attention to the reduced number of the hospitalization needed for the patients under treatment.