TRI MATCH COMPARISON OF THE EFFICACY OF FLOSEAL® VS TACHOSIL® VS NO HEMOSTATIC AGENTS FOR PARTIAL NEPHRECTOMY: RESULTS FROM A LARGE MULTICENTER DATASET (RECORD PROJECT)
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Data di Pubblicazione:
2014
Citazione:
TRI MATCH COMPARISON OF THE EFFICACY OF FLOSEAL® VS TACHOSIL® VS NO HEMOSTATIC AGENTS FOR PARTIAL NEPHRECTOMY: RESULTS FROM A LARGE MULTICENTER DATASET (RECORD PROJECT) / A. Antonelli, A. Minervini, A. Mari, G. Bianchi, C. Fiori, A. Lapini, N. Longo, G. Martorana, V. Mirone, G. Morgia, F. Porpiglia, B. Rocco, R. Schiavina, S. Serni, M. Sodano, C. Terrone, A. Volpe, F. Zattoni, V. Ficarra, C. Simeone, M. Carini. ((Intervento presentato al convegno 87° Congresso Nazionale SIU Società Italiana di Urologia tenutosi a Firenze nel 2014.
Abstract:
Aim of the study
The aim of this study is to investigate the efficacy of hemostatic agents (HA) in Nephron Sparing Surgery
(NSS). A three-matched comparison between patients treated with no HA, with Tachosil® and with
Floseal® was performed.
Materials and methods
Observational multicentre study (RECORd Project) collects the data of 1055 patients who underwent PN
between January 2009 and December 2012 at 19 Italian centres. Cases treated with more than one HAor
with HA other than Floseal® or Tachosil® were excluded. A tri-match propensity score analysis was applied
to create 3 groups - no HA group, Floseal® group, Tachosil® group - balanced for gender, age, surgical
indication (elective/relative vs imperative), clinical stage (cT1a vs cT1b), tumour growth pattern, surgical
approach (open vs minimally invasive), surgical technique (standard PN vs simple enucleation), preoperative
haemoglobin and preoperative creatinine. The three groups were compared regarding the main intra and
post-operative outcomes.
Results
The study excluded 255 patients treated with more than one HA and were submitted 131 cases to no
HA group, 200 to Tachosil® group, 489 to Floseal® group. In the original cohort significant differences
among groups in terms of patient, tumor and surgical features were detected, so that a tri-match analysis
for 66 triplets well balanced triplets were performed. The three matched cohorts presented a significant
difference in EBL, lower in the Floseal® group, but this result lost significance if clinical important EBL
was considered (>400 cc). No significant difference was found between three groups regarding medical
and surgical post-operative overall complications, surgical haemorrhagic Clavien 2 and 3 complications,
variation of haemoglobin and creatinine values between preoperative and 3rd post-operative day.
Discussion
In order to reduce hemorrhage during NSS the use of biological HA is increasing, but literature on this
subject is limited to some cases series, few retrospective studies and one randomized trial. Among the three
groups, no differences were detected in the rates of medical and surgical complications, transfusion and
re-intervention due to bleeding, as in variations between pre and postoperative levels of hemoglobin and
glomerular filtration rate, overall and pairwise. Therefore, from these results, it seems that HA cannot exert
any significantly protective effect against bleeding with respect to standard suturing. A possible explication
is that HA is often used improperly or indiscriminately. This statement is indirectly confirmed by the fact
that, in spite of their frequent use, a reduction in the rate of bleeding was not observed in recent with respect
to past series of PN.
Conclusions
No differences in terms of overall and bleeding complications were detected among patients submitted to
NSS without using HA, using Floseal® or Tachosil®. There is no clear evidence that the use of HA, in
addition to sutures, can improve haemostasis after PN
Tipologia IRIS:
14 - Intervento a convegno non pubblicato
Elenco autori:
A. Antonelli, A. Minervini, A. Mari, G. Bianchi, C. Fiori, A. Lapini, N. Longo, G. Martorana, V. Mirone, G. Morgia, F. Porpiglia, B. Rocco, R. Schiavina, S. Serni, M. Sodano, C. Terrone, A. Volpe, F. Zattoni, V. Ficarra, C. Simeone, M. Carini
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