Evaluation of a hemostatic sponge (TachoSil) for sealing of the renal collecting system in a porcine laparoscopic partial nephrectomy survival model.

ABSTRACT

OBJECTIVE: The objective of this study was to evaluate the efficacy of TachoSil (Nycomed UK, Oxford, Buckinghamshire, UK), a hemostatic sponge, to seal major collecting system injuries (in addition to providing an adjunct to hemostasis) after partial nephrectomy in a porcine chronic survival model. MATERIALS AND METHODS: Laparoscopic upper-pole partial nephrectomies were performed in 10 farm pigs (>40 kg). After hilar clamping, an energyless incision was made at a point halfway between the hilum and the upper pole of the kidney and the collecting system was opened widely. TachoSil was applied to cover the defect; 15 to 20 minutes after the application of TachoSil, the hilar clamp was removed, hemostasis confirmed, and the pig survived. Assessment was made for hematoma and urinoma. Four weeks postoperatively, the pigs were euthanized. Ex-vivo retrograde studies were performed to assess collecting system leak. Weight, blood pressure, estimated blood loss, the weight of the partial and completion nephrectomy specimen, presence/absence of urinary leak on retrograde study, histopathologic findings, and complications were recorded. RESULTS: All pigs survived. Mean warm ischemia time was 18 minutes, mean blood loss was 90 mL, and mean resected weight was 13.7 g. There was no evidence of leak on retrograde study. Histologically, nonspecific changes were noted in all specimens, which included dystrophic calcification, scarring, and areas of fibrosis at the partial nephrectomy surgical margin. CONCLUSION: TachoSil seals the collecting system after partial nephrectomy on a porcine chronic survival model, in addition to providing an adjunct to hemostasis. More studies, including human trials, are warranted to evaluate this observation further.