Clinical trial · Interventional
Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy
Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemostatic Agent | Device | — | UNRESOLVED |
| No Hemostatic Agent | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (Hemostatic Agents Plus +)
- interventionNames
- Device: Hemostatic Agent
- type
- ACTIVE_COMPARATOR
- label
- Group 2 (Hemostatic Agents Negative -)
- description
- No Hemostatic Agent
- interventionNames
- Other: No Hemostatic Agent
Primary outcomes (1)
- measure
- An absolute change in hemoglobin
- timeFrame
- up to 6 months
- description
- The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLazarovich 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