NCT07668817NARecruiting
Tract Closure in PCNL
Icahn School of Medicine at Mount Sinai
Start Date
7/1/2026
Completion Date
6/1/2028
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 Criteria
Age Range: 18 years to No maximum
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
DEVICE
Floseal
DEVICE
Surgicel
DEVICE
Surgiflo
PROCEDURE
Balloon Tamponade
Conditions
Nephrolithiasis
Locations
Mount Sinai West
New York, New York 10019
United States