Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

Withdrawn before enrolling · Not applicable

Conditions studied: Robotic-Assisted Laparoscopic Partial Nephrectomy, Hemostatic Agents, Renal Malignant Tumor

In brief

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.

Key facts

Study ID

NCT03528057

Run by

Northwestern University

People needed

0

Starts

2018-04-18

Expected to finish

2020-06-01

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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