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The purpose of this study is to evaluate the necessity of using hemostatic agents as a tool when performing robotic partial nephrectomy in the treatment of kidney cancer. This project asks whether patients who undergo robotic partial nephrectomy without the surgeon using hemostatic agents during the procedure will have the same, fewer, or more complications than when patients undergo this same surgery with the surgeon using hemostatic agents during the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Hemostatic Agents Plus +) | Experimental |
| |
| Group 2 (Hemostatic Agents Negative -) | Active Comparator | No Hemostatic Agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemostatic Agent | Device | Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon |
|
| Measure | Description | Time Frame |
|---|---|---|
| An absolute change in hemoglobin | The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of major bleeding complications | Major complications are blood loss requiring transfusion of packed red blood cells, reoperation and endovascular ablation | up to 6 months |
| Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arieh Shalhav, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41360001 | Derived | Lazarovich A, Tremblay S, Nottingham C, Lescay H, Nusbaum DJ, Cooper C, Labbate C, Bristol S, Karrison T, Shalhav AL, Eggener S. Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy. J Urol. 2026 May;215(5):526-534. doi: 10.1097/JU.0000000000004889. Epub 2025 Dec 8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2026 | |
| Reset | Apr 13, 2026 | |
| Release | Apr 16, 2026 | |
| Reset | May 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2026 | Apr 13, 2026 | |||
| Apr 16, 2026 |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| No Hemostatic Agent | Other | Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon |
|
Safety monitoring parameters including stroke, death, cardiac arrest, myocardial infarction and urine leak |
| up to 6 months |
| Operating room parameters | Operating room parameters including number of sutures used during renorrhaphy and capsular closure, duration of renorrhaphy and patients in group 2 with no hemostatic agents who required HA at the surgeons discretion | up to 6 months |
| Patients with a hospital stay over 30 days | Total length of all inpatient hospital stay over 30 days measured in days | up to 6 months |
| May 7, 2026 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |