Randomized Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

• Hemostatic Agent (Device): Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
• No Hemostatic Agent (Other): Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon

Primary outcomes

• Change in Hemoglobin [1 day]: The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively (day 1) and the hemoglobin obtained preoperatively (on the day of surgery before the operation).

Secondary outcomes

• Total Number of Patients With Major Bleeding Complications [up to 30 days]: Major bleeding complications is a composite outcome including blood products transfusion, reoperation, or the need for endovascular evaluation or embolization.
• Safety Monitoring Parameters: Number of Participants With Surgery-related Adverse Event (Stroke, Death, Cardiac Arrest, Myocardial Infarction, or Urine Leak) [up to 30 days]: Safety monitoring parameters included stroke, death, cardiac arrest, myocardial infarction and urine leak.
• Duration of Renorrhaphy [Up to 24 hours]
• Number of Sutures Used During Renorrhaphy and Capsular Closure. [Up to 24 hours]
• HA Required [Up to 24 hours]: The number of patients in group 2 (HA-) who required hemostatic agents at the surgeon's discretion.
• Patients With a Hospital Stay Over 30 Days [up to 6 months]: Total length of all inpatient hospital stay over 30 days measured in days

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Male and female patients aged 18 years and older.
2. Patients must have a solid or cystic renal mass suspicious for malignancy by imaging with ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
3. Patients must be initially scheduled RALPN as opposed to radical nephrectomy or other techniques for partial nephrectomy such as open surgery or pure laparoscopy without robot assistance.
4. Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney.
5. Patients can have the common single renal artery and single renal vein, or they can have common variants such as two renal arteries and/or two renal veins.

Exclusion Criteria:

1. Patients on hemodialysis.
2. Patients who have had a renal transplantation.
3. Patients on therapeutic anticoagulation prior to surgery (example anticoagulants include: aspirin 325 mg daily, clopidogrel, warfarin, fondaparinux, dabigatran, and rivaroxaban). However, patients who take aspirin 81 mg daily as their daily regimen will be included.
4. Patients with bleeding disorders (example: hemophilia) and other documented coagulopathy (example: chronic liver disease) with INR greater than 1.0 at baseline.
5. Patients who have had a prior surgical procedure, aside from percutaneous renal biopsy, on the kidney in the current operation.
6. Patients with over 100 mL of estimated blood loss (calculated by anesthesia team using the suction canisters) prior to clamping of the renal hilum will be excluded.

Participant flow

Outcome results

• Change in Hemoglobin (Primary), Mean, g/dL: Group 1 (Hemostatic Agents Plus +) -1.8 (-2.1 to -1.4); Group 2 (Hemostatic Agents Negative -) -1.7 (-2.0 to -1.4) (p 0.5)
• Total Number of Patients With Major Bleeding Complications (Secondary), Count of participants, Participants: Group 1 (Hemostatic Agents Plus +) 6; Group 2 (Hemostatic Agents Negative -) 4 (p 0.7)
• Safety Monitoring Parameters: Number of Participants With Surgery-related Adverse Event (Stroke, Death, Cardiac Arrest, Myocardial Infarction, or Urine Leak) (Secondary), Count of participants, Participants: Group 1 (Hemostatic Agents Plus +) 2; Group 2 (Hemostatic Agents Negative -) 1 (p 0.92)
• Duration of Renorrhaphy (Secondary)
• Number of Sutures Used During Renorrhaphy and Capsular Closure. (Secondary)
• HA Required (Secondary), Count of participants, Participants: Group 1 (Hemostatic Agents Plus +) 0; Group 2 (Hemostatic Agents Negative -) 6
• Patients With a Hospital Stay Over 30 Days (Secondary), Count of participants, Participants: Group 1 (Hemostatic Agents Plus +) 0; Group 2 (Hemostatic Agents Negative -) 0

Adverse events

Time frame: 30 days

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 41360001

• Study Protocol and Statistical Analysis Plan (PDF, 2018-10-10)

• Arieh Shalhav, MD, Principal investigator, University of Chicago