Clinical trial · Interventional
Evaluation of Hemostatic Agents in Robotic-assisted 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
Why stopped (as posted): Difficulty recruiting participants.
Summary
Brief summary (as posted)
The aim of this study is to evaluate whether Hemostatic Agents (HA) make a significant clinical difference in patient outcomes when used for Robotic-Assisted Laparoscopic Partial Nephrectomy (RALPN). The result of this trial will determine whether HAs are necessary for use during RALPN or if they can be omitted from the surgical tools available during this procedure. This study has a direct clinical implication on a patient's outcomes following RALPN, specifically whether patients will have better, worse, or unchanged outcomes with RALPN if HAs are used.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemostatic Agents | — | UNRESOLVED | — |
| Renal Malignant Tumor | Renal Cell Carcinoma | PROBABILISTIC | 0.70 |
| Robotic-Assisted Laparoscopic Partial Nephrectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemostat | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- Patients undergoing RALPN with the use of HAs by a surgeon.
- interventionNames
- Device: Hemostat
- type
- NO_INTERVENTION
- label
- Group 2
- description
- Patients undergoing RALPN without the use of HAs by a surgeon
Primary outcomes (1)
- measure
- Absolute change in hemoglobin
- timeFrame
- Morning after surgery
- description
- This will be measured as the difference between the hemoglobin obtained postoperatively (measured at approximately 4 am in the morning after surgery) and the hemoglobin obtained preoperatively in the holding area on the day of surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients aged 18 years and older. * 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). * 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. * Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney. * 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: * Patients on hemodialysis. * Patients who have had a renal transplantation. * 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. * Patients with bleeding disorders (example: hemophilia) and other documented coagulopathy (example: chronic liver disease) with international normalized ratio (INR) \> 1.0 at baseline. * Patients who have had a prior surgical procedure, aside from percutaneous renal biopsy, on the kidney in the current operation. * 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 (0)
Data not yet available