EFFICACY OF FLOSEAL® VERSUS TACHOSIL® VERSUS NO HEMOSTATIC AGENTS FOR NEPHRON SPARING SURGERY: A PROSPECTIVE MULTICENTER COMPARATIVE STUDY (RECORD PROJECT)

Aim of the study To evaluate the efficacy of FloSeal® versus TachoSil® versus no he- mostatic agents for nephron sparing surgery (NSS) in a prospective multicenter dataset. Materials and methods The RECORd Project is a 4-year prospective observational multi- center study promoted by SIU. The study includes all patients who underwent open or laparoscopic NSS between January 2009 and January 2011 at 19 Italian centers. Approval of the study proto- col by the local ethical committee was obtained. All intraoperative data including whether or not to clamp the renal vessels, type of haemostatic agent and intraoperative blood loss were recorded. Postoperative bleeding requiring blood transfusion/reintervention and cardiovascular complications occurring within 30 days, were recorded. Univariable analysis was used to evaluate the association between type of hemostatic agent used and both the need for blood transfusion/reintervention and the risk of cardiovascular complica- tions. Multivariable logistic regression model was applied to ana- lyze predictors of postoperative blood transfusion/reintervention for bleeding. Results A total of 418 patients were recruited, following exclusion of patients with incomplete data on the type of haemostatic agent adopted and of patients treated with both haemostatic agents (FloSeal® and Ta- choSil®). Overall 231 had FloSeal® NSS; 116 TachoSil® NSS and 71 had pure NSS without the adoption of any haemostatic product. Clinical dimension did not differ among the three groups. Overall, 41 postoperative bleeding requiring blood transfusion/reinterven- tion (9.8%) and 7 cardiovascular events (1.7%) occurred. Overall, 9.3% of FloSeal® NSS, 7.9% of TachoSil® NSS and 15.7% of pure NSS had postoperative bleeding requiring blood transfusion/reinter- vention (FloSeal® and TachoSil® vs. pure, p=0.05). Moreover, 0.9% of FloSeal® NSS, 0.9% of TachoSil® NSS and 5.7% of pure NSS had cardiovascular complications (FloSeal® vs. pure, p=0.035; Ta- choSil® vs. pure, p=0.05). Multivariate analysis showed that factors correlated with postoperative bleeding requiring blood transfusion/ reintervention were preoperative haemoglobin level, ECOG score (≥1), the lack of haemostatic agents and tumor growth pattern (>50% endphytic) while it was not influenced by the tumor location (polar vs. mesorenal), the surgical approach (open vs. laparoscopic), the surgical technique (Standard PN vs. SE) and the decision wheth- er or not to clamp the renal vessels. Discussion This study represents the first prospective comparative multicenter study between FloSeal® NSS, TachoSil® NSS and pure NSS with no hemostatic agents. Conclusions In our series the risk of postoperative bleeding was significantly and independently associated with the lack of any hemostatic agents. Both FloSeal® and TachoSil® seem protective against postoperative bleeding and are used in different settings according to tumor char- acteristics, surgical approach and surgeon’s attitude.