Nephrolithiasis
Conditions
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.
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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin from baseline to PACU | Baseline and Post-operative Day 0 | Change in Hemoglobin from preoperative baseline CBC to PACU CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin from baseline to Post-operative Day 10 | Baseline and Post-operative Day 10 | Change in Hemoglobin from preoperative baseline CBC to postoperative day 10 CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells. |
| Ureteroscopic tract bleeding score | Post-operative Day 0 | Ureteroscopic tract bleeding score provides a direct, anatomically specific measure of tract hemostasis that complements laboratory-based bleeding outcomes. Bleeding score is based on a 0-3 ordinal scale. 0 equals no visible tract bleeding whereas 3 equals active tract bleeding that significantly impairs visualization. Higher score indicates more bleeding and poor health outcome. |
| Proportion of participants undergoing stent placement | Post-operative Day 0 | Proportion of participants undergoing stent placement at procedure completion. Drainage decisions reflect surgeon assessment of tract bleeding and represent a clinically meaningful downstream consequence of hemostasis. This is measured as a binary patient-level outcome (stent placed: yes/no) |
| Number of bleeding related events | Post-operative Day 30 | Number of bleeding related events within 30 days ensures adjunctive hemostatic agent use does not introduce excess bleeding-related morbidity. |
Countries
United States
Contacts
CONTACTMantu Gupta, MD
CONTACTBlair Gallante, MPH
PRINCIPAL_INVESTIGATORMantu Gupta, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed