Tract Closure in PCNL

Purpose

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.

Condition

  • Nephrolithiasis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Balloon Tamponade with no hemostatic agent 		Balloon tamponade alone with no hemostatic agent acts as a control.
  • Procedure: Balloon Tamponade
    Balloon tamponade is utilized to manage tract related bleeding.
Experimental
Balloon Tamponade with Floseal 		Balloon tamponade with Floseal as hemostatic agent.
  • Device: Floseal
    Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.
  • Procedure: Balloon Tamponade
    Balloon tamponade is utilized to manage tract related bleeding.
Experimental
Balloon Tamponade with Surgicel 		Balloon Tamponade with Surgicel as hemostatic agent.
  • Device: Surgicel
    SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.
  • Procedure: Balloon Tamponade
    Balloon tamponade is utilized to manage tract related bleeding.
Experimental
Balloon Tamponade with Surgiflo 		Balloon tamponade with Surgilfo as hemostatic agent.
  • Device: Surgiflo
    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.
  • Procedure: Balloon Tamponade
    Balloon tamponade is utilized to manage tract related bleeding.

Recruiting Locations

Mount Sinai West
New York, New York 10019
Contact:
Mantu Gupta, MD
212-241-1272
mantu.gupta@mountsinai.org

More Details

Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Mantu Gupta, MD
212-241-1272
mantu.gupta@mountsinai.org