This is a prospective, randomized controlled trial evaluating the effect of a hemostatic agent on tract-related bleeding during percutaneous nephrolithotomy (PCNL). Patients undergoing standardized PCNL will be randomized to receive either application of a hemostatic agent or no agent during tract closure, following uniform balloon occlusion, complete aspiration, and irrigation-free endoscopic assessment. The researchers hypothesize that adjunctive hemostatic agent use reduces perioperative hemoglobin decline compared with balloon tamponade alone and improves tract-related hemostasis outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.
SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.
SURGIFLO® Hemostatic Matrix is an Ethicon porcine gelatin-based, flowable hemostatic agent used to stop bleeding during surgery, typically reaching hemostasis within seconds to minutes.
Mount Sinai West
New York, New York, United States
RECRUITINGChange in hemoglobin from baseline to PACU
Change in Hemoglobin from preoperative baseline CBC to PACU CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells.
Time frame: Baseline and Post-operative Day 0
Change in Hemoglobin from baseline to Post-operative Day 10
Change in Hemoglobin from preoperative baseline CBC to postoperative day 10 CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells.
Time frame: Baseline and Post-operative Day 10
Ureteroscopic tract bleeding score
Ureteroscopic tract bleeding score provides a direct, anatomically specific measure of tract hemostasis that complements laboratory-based bleeding outcomes. Bleeding score is based on a 0-3 ordinal scale. 0 equals no visible tract bleeding whereas 3 equals active tract bleeding that significantly impairs visualization. Higher score indicates more bleeding and poor health outcome.
Time frame: Post-operative Day 0
Proportion of participants undergoing stent placement
Proportion of participants undergoing stent placement at procedure completion. Drainage decisions reflect surgeon assessment of tract bleeding and represent a clinically meaningful downstream consequence of hemostasis. This is measured as a binary patient-level outcome (stent placed: yes/no)
Time frame: Post-operative Day 0
Number of bleeding related events
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Balloon tamponade is utilized to manage tract related bleeding.
Number of bleeding related events within 30 days ensures adjunctive hemostatic agent use does not introduce excess bleeding-related morbidity.
Time frame: Post-operative Day 30