Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
Icahn School of Medicine at Mount Sinai
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * At least one stone ≥ 1.2cm * Scheduled to undergo planned PCNL * Age ≥ 18 years Exclusion criteria: * Unable to provide informed consent * Pre-existing nephrostomy tube * Multi access cases * Stone in calyceal diverticulum/hydrocalyx * Preoperatively planned overnight admission for any reason * Infundibular stenosis * Coagulation disorders * Other significant anatomic abnormalities
Interventions
- DeviceFloseal
Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.
- DeviceSurgicel
SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.
- DeviceSurgiflo
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.
- ProcedureBalloon Tamponade
Balloon tamponade is utilized to manage tract related bleeding.
Location
- Mount Sinai WestNew York, New York