Abstract
Objectives: Results of prospective randomized study to assess the influence of Tachosil® applied on mediastinum after systematic lymphadenectomy are presented.
Material and methods: In 28 patients from the Tachosil® group 1 to 3 large pieces of Tachosil® (mean 1.8, SD±0.7) were applied, while in 22 patient from the control group only coagulation was allowed. Clinical data were collected, and pleural concentrations of IL-6, IL-1ra and IL-8 on postoperative days 1, 2 and 3 were measured, with ELISA method.
Results: Both groups were well balanced according to sex, age, number of packyears of cigarettes, time from smoking cessation, pulmonary function test results, concomitant diseases, BMI index, number of N1 and N2 nodes resected, and perioperative serum concentrations of IL-6, IL-1ra and L-8. Postoperative complications occurred in 8/29 and 12/24 patients from each group (p=0.046), respectively, with no mortality. No differences in time of surgery, intraoperative blood loss, amount of drainage and drainage hemoglobin concentration on postoperative days 1, 2 and 3, time to drainage removal and number of blood units transfused between the groups were observed. The summarized postoperative pleural drainage was lower in the Tachosil® group (p=0.03). Concentration of IL-6 in pleural drainage was higher in the Tachosil® group on the first (p=0.01) and the second (p=0.03) postoperative days. Positive correlation between number of blood units transfused and pleural concentration of hemoglobin on subsequent postoperative days in the whole group but not in Tachosil® group was found.
Conclusions: This study showed a significant impact of application of Tachosil® on mediastinum after systematic lymphadenectomy on clinical outcome due to decreased amount of total postoperative drainage and decreased rate of complications. A higher concentration of IL-6 in pleural fluid on postoperative day 1 and 2 may reflect a minor local immune response to Tachosil®, without elevation of concentration of other cytokines and without negative impact on postoperative complications. Blood transfusions in patients from the Tachosil® group were rather due to preoperative anemia and intraoperative blood loss, unlike in the control group where blood transfusions were rather due to postoperative blood loss with pleural drained fluid.