Will Renorrhaphy Become Obsolete? Evaluation of a New Hemostatic Sealant

Abstract

Background: In robot-assisted partial nephrectomy (RAPN) renorrhaphy is used to achieve hemostatic control of the tumoral resection bed, with detrimental impact on renal function. Hemostatic agents are used to achieve rapid and optimal hemostasis. GATT-Patch is a new hemostatic sealant that has already demonstrated promising results. Objective: Compare GATT-Patch and standard renorrhaphy in terms of hemostatic capacity, ischemia time, and prevention of urinary leakage after RAPN in a porcine model. Design, Setting, and Participants: In this preclinical randomized controlled trial, four pigs underwent 32 RAPNs. After resection, GATT-Patch application and performance of classic renorrhaphy were randomized. After the procedure, the resection bed was reinspected. A necropsy study evaluated the adhesiveness of the patch, and retrograde pyelography was performed to determine the leakage burst pressure. Intervention: Application of GATT-Patch and performance of classic renorrhaphy were randomized and surgeons blinded to the hemostatic technique to be performed. Outcome Measurements and Statistical Analysis: Warm ischemia, hemostatic control, active bleeding during hemostatic control, total procedure time, bleeding at reinspection, and presence of urinary leakage on retrograde pyelography were recorded. Continuous variables were compared using the Student t-test. Categorical variables were compared using the Chi-square or Fisher's exact test. Results and Limitations: GATT-Patch reduced warm ischemia time (WIT), time to achieve hemostatic control, active bleeding time, and total procedure time, achieving hemostasis in 100% of the cases. Rebleeding at reinspection occurred in 0% of the GATT-Patch group. Renal parenchyma damage was observed in 100% of renorrhaphy cases and in 0% of GATT-Patch cases. Conclusions: GATT-Patch guaranteed optimal hemostasis and urine sealant effect after RAPN in porcine models. Compared to renorrhaphy, we observed a reduction in WIT, total procedure time, and potential reduction in healthy parenchyma loss. Patient Summary: GATT-Patch stops bleeding and provides hemostasis faster than suturing after resection of portions of the kidney in pigs. It might be tested in patients undergoing partial nephrectomy for kidney cancer.

Keywords: GATT-Patch; hemostatic sealant; partial nephrectomy; renorrhaphy; robotic surgery.