Efficacy and safety of TachoSil as haemostatic treatment versus standard suturing in kidney tumour resection: a randomised prospective study.
OBJECTIVE
Elective nephron-sparing surgery (NSS) for renal cell carcinoma (RCC) has gained general acceptance as an alternative to radical nephrectomy. To achieve haemostasis without risk of local ischaemia and necrosis of kidney parenchyma after standard haemostatic suturing, we investigated TachoSil's efficacy and safety as atraumatic haemostatic treatment after kidney tumour resection.


METHODS
A total of 185 patients scheduled for NSS for small, superficial kidney tumours were included in an open, randomised, prospective, multicentre, parallel-group trial. Primary objectives were to test haemostatic efficacy and safety of TachoSil versus standard suturing. Efficacy was tested by comparing intraoperative time to haemostasis (primary end point). Secondary objectives included proportion of subjects with haemostasis after 10 min of trial treatment, occurrence of haematoma on day 2 after surgery, volume and haemoglobin concentration of postoperative drainage fluid, and surgeon's rating of usefulness of trial treatments. Safety was evaluated by occurrence of adverse events.


RESULTS
In the intent-to-treat population, time to haemostasis was significantly shorter with TachoSil versus standard suturing (mean: 5.3 vs. 9.5 min [p<0.0001]). Haemostasis was obtained within 10 min in 92% of patients in the TachoSil group and in 67% in the standard treatment group (p<0.0001). Differences in other secondary end points were not statistically significant. Both treatments were well tolerated. Surgeons rated TachoSil higher in terms of convenience to prepare and apply, and impression of efficacy.


CONCLUSIONS
TachoSil was superior to standard suturing in obtaining intraoperative control of haemorrhage and was as well tolerated as standard haemostatic treatment during NSS.
Siemer
Stefan
S
Department of Urology and Paediatric Urology, University of Saarland, Homburg, Germany. stefan.siemer@uniklinikum-saarland.de
Lahme
Sven
S
Altziebler
Stefan
S
Machtens
Stefan
S
Strohmaier
Walter
W
Wechsel
Hans-W
HW
Goebell
Peter
P
Schmeller
Nicolaus
N
Oberneder
Ralph
R
Stolzenburg
Jens-Uwe
JU
Becker
Hermann
H
Lüftenegger
Werner
W
Tetens
Vilhelm
V
Van Poppel
Hein
H
D002292:Carcinoma, Renal Cell / Q000601:surgery*; D004338:Drug Combinations; D005340:Fibrinogen / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins; D006487:Hemostasis; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007680:Kidney Neoplasms / Q000601:surgery*; D007700:Kinetics; D008875:Middle Aged; D010976:Platelet Count; D012449:Safety; D015503:Surgical Sponges; D013537:Sutures; D013917:Thrombin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D004338:Drug Combinations; D006454:Hemoglobins; D006490:Hemostatics; C518955:TachoSil; D005340:Fibrinogen; D013917:Thrombin