UROGENITAL TRAUMA

Improvement of hemostasis in open and laparoscopically performed partial nephrectomy using a gelatin matrix-thrombin tissue sealant (FloSeal)
Richter F, Schnorr D, Deger S, Trk I, Roigas J, Wille A, Loening SA.
Klinik und Poliklinik fur Urologie, Humboldt Universitat (Charite’) Berlin,
Berlin, Germany.
Urology 2003; 61: 73-7

• Objectives: Long-term follow-up studies have demonstrated that effective local tumor control and long-term tumor-free progression rates can be achieved by nephron-sparing surgery. However, hemostasis is a major issue, and the lack of effective means of hemostasis has limited the wider use of the laparoscopic approach to nephron-sparing surgery.
• Methods: Between January 2001 and April 2002, 25 patients with renal cell carcinoma were treated with partial nephrectomy using a two-component tissue sealant (FloSeal). The median age was 54 years (range 42 to 71). The follow-up time was 1 to 12 months (median 3.5). The tumor diameter ranged from 2 to 5 cm (median 2.8). Fifteen cases were performed by open retroperitoneal surgery, and 10 cases were performed laparoscopically. The two-component tissue sealant (consisting of a gelatin matrix granula component and a thrombin component) was applied after resection of the tumor and before perfusion of the kidney. The following parameters were recorded: time until complete hemostasis was achieved; decrease in postoperative hemoglobin level; postoperative bleeding; and presence or absence of a perirenal hematoma 24 hours and 10 days postoperatively by ultrasonography.
• Results: After application of the tissue sealant for 1 to 2 minutes to the moist resection site, hemostasis was immediate in all cases. During the laparoscopically performed partial nephrectomies, a laparoscopic applicator was used to avoid wasting the tissue sealant within the dead space of the instrument. When reperfusion of the kidney was established, hemostasis was maintained. The decrease in postoperative hemoglobin level ranged from 0.3 to 1.2 points (median 0.7). None of the patients required blood transfusions. No postoperative bleeding occurred. The ultrasound examination 24 hours and 10 days postoperatively demonstrated the absence of a significant perirenal hematoma.
• Conclusions: The two-component tissue sealant FloSeal provided immediate and durable hemostasis in open and laparoscopically performed partial nephrectomies. The tissue sealant may provide a tool to expand the possibilities of laparoscopic nephron-sparing surgery.
  
• Editorial Comment
  Major bleeding is an issue for both renal trauma surgery and partial nephrectomy. In this study, the authors validate the use of a novel thrombin hemostatic agent that works much better than any similar material from the past, for use against bleeding seen in laparoscopic partial nephrectomy. Although not specifically a trauma study, I believe that the hemostasis seen in this study could also be welcome in renal trauma surgery (renorrhaphy). In the past, few hemostatic agents had been truly helpful in stemming hemorrhage from the bleeding kidney, and intraoperative and postoperative blood loss remained a problem. Worse, during some renal trauma surgery, potentially salvageable kidneys were removed iatrogenically because of brisk bleeding. Now, the invention of highly concentrated thrombin in a gelatin matrix (FloSeal; Baxter) allows the stemming of even spurting blood, and forms a clot, which is both strong and lasting. This will surely decrease the nephrectomy rate during attempted renorrhaphy.
  Company literature shows Floseal stopping bleeding from experimentally lacerated porcine heart and inferior vena cava. The clot that is formed is not pushed out by the pressure of blood, even in the heart. I have personally validated these findings in pigs, where FloSeal stopped bleeding from stab wounds to the liver, spleen and kidney almost instantaneously, and stopped bleeding from lacerated IVC after 3 minutes of light pressure with a moist sponge. In humans, I have used FloSeal in open partial nephrectomy with identically excellent results to this paper. No renal vessels needed ligation, and no persistent or late bleeding was seen. A second application of Floseal is sometimes needed if the first application does not stop all the bleeding. Warm ischemia time is decreased to minutes, even in large partial nephrectomy cases.
  In this study, Floseal was used in 25 partial nephrectomy patients as the sole means of bleeding control. 15 had open operations and 10 had laparoscopic surgery. Average time to complete hemostasis was less than 2 minutes, and no patients had postoperative bleeding. Finally, it appears that a very effective hemostatic agent is available for our everyday use.

Dr. Richard A. Santucci
Assistant Professor of Urology
Wayne State University
Detroit, Michigan, USA