Tract Closure in PCNL

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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

Qualifiers

At least one stone ≥ 1.2cm

Scheduled to undergo planned PCNL

Age ≥ 18 years

Disqualifiers

Unable to provide informed consent

Pre-existing nephrostomy tube

Multi access cases

Stone in calyceal diverticulum/hydrocalyx

Trial design

Treatments tested in this trial

  • Floseal
  • Surgicel
  • Surgiflo
  • Balloon Tamponade

Treatment groups

92 Participants
are divided into 4 treatment groups