Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 92
- Locations
- 1
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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
Arms & Interventions
Balloon Tamponade with Surgicel
Balloon Tamponade with Surgicel as hemostatic agent.
Intervention: Surgicel (Device)
Balloon Tamponade with Floseal
Balloon tamponade with Floseal as hemostatic agent.
Intervention: Balloon Tamponade (Procedure)
Balloon Tamponade with no hemostatic agent
Balloon tamponade alone with no hemostatic agent acts as a control.
Intervention: Balloon Tamponade (Procedure)
Balloon Tamponade with Floseal
Balloon tamponade with Floseal as hemostatic agent.
Intervention: Floseal (Device)
Balloon Tamponade with Surgicel
Balloon Tamponade with Surgicel as hemostatic agent.
Intervention: Balloon Tamponade (Procedure)
Balloon Tamponade with Surgiflo
Balloon tamponade with Surgilfo as hemostatic agent.
Intervention: Surgiflo (Device)
Balloon Tamponade with Surgiflo
Balloon tamponade with Surgilfo as hemostatic agent.
Intervention: Balloon Tamponade (Procedure)
Investigators
Mantu Gupta
Professor of Urology
Icahn School of Medicine at Mount Sinai