Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy.

Abstract

Hemostatic agents (HAs) are typically used during robotic-assisted laparoscopic partial nephrectomy (RALPN) to minimize perioperative bleeding. However, high-quality evidence supporting their effectiveness is limited. We aimed to determine whether HAs reduce perioperative blood loss in patients undergoing RALPN. We conducted a prospective, randomized controlled trial of patients undergoing RALPN. Patients were randomized to HA+, in which HAs were assigned, and HA-, no HA. The primary end point was mean change in hemoglobin from preoperative baseline to postoperative day 1. Secondary outcomes included major bleeding complications (blood transfusion, reoperation, and endovascular intervention), length of stay, and 30-day readmission. A total of 208 patients were randomized, and 178 patients were included in the final modified intention-to-treat analysis (88 HA-, 90 HA+). The mean hemoglobin decrease was 1.7 g/dL (95% CI: 1.4-2.0) in the HA- group and 1.8 g/dL (95% CI: 1.4-2.1) in the HA+ group (<i>P</i> = .5, 95% CI for group difference: [0.26]-0.48). The mean estimated blood loss in the HA- group was 116 cc (95% CI: 96-136) and in the HA+ group was 114 cc (95% CI: 88-140; <i>P</i> = .3). We found no significant difference in major bleeding complications (<i>P</i> = .7, 95% CI for group difference: [-5.4%] to 9.8%), as 4 patients (4.5%) in the HA- group and 6 patients (6.7%) in the HA+ experienced major bleeding complications. Routine use of HAs during RALPN does not seem to lower the risk for bleeding after surgery, as measured by the change in hemoglobin levels or major bleeding complications.