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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Tamponade with no hemostatic agent | Active Comparator | Balloon tamponade alone with no hemostatic agent acts as a control. |
|
| Balloon Tamponade with Floseal | Experimental | Balloon tamponade with Floseal as hemostatic agent. |
|
| Balloon Tamponade with Surgicel | Experimental | Balloon Tamponade with Surgicel as hemostatic agent. |
|
| Balloon Tamponade with Surgiflo | Experimental | Balloon tamponade with Surgilfo as hemostatic agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floseal | Device | Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin from baseline to PACU | 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. | Baseline and Post-operative Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin from baseline to 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mantu Gupta, MD | Contact | 212-241-1272 | mantu.gupta@mountsinai.org | |
| Blair Gallante, MPH | Contact | 212-241-1272 | blair.gallante@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Mantu Gupta, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | Recruiting | New York | New York | 10019 | United States |
To protect participant privacy
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D021721 | Balloon Occlusion |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D058450 | Endotamponade |
| D006489 | Hemostatic Techniques |
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| Surgicel | Device | SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding. |
|
| Surgiflo | Device | 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. |
|
| Balloon Tamponade | Procedure | Balloon tamponade is utilized to manage tract related bleeding. |
|
| Baseline and Post-operative Day 10 |
| Ureteroscopic tract bleeding score | 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. | Post-operative Day 0 |
| Proportion of participants undergoing stent placement | 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) | Post-operative Day 0 |
| Number of bleeding related events | Number of bleeding related events within 30 days ensures adjunctive hemostatic agent use does not introduce excess bleeding-related morbidity. | Post-operative Day 30 |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D004621 |
| Embolization, Therapeutic |
| D060205 | Therapeutic Occlusion |
| D008919 | Investigative Techniques |