Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

The University of Chicago

Status: Active, not recruiting

Conditions: Kidney Cancer

Treatments: Device: Hemostatic Agent; Other: No Hemostatic Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT04120805

IRB15-0519

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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178 participants in 2 patient groups

Group 1 (Hemostatic Agents Plus +)

Experimental group

Treatment:

Device: Hemostatic Agent

Group 2 (Hemostatic Agents Negative -)

Active Comparator group

Description:

No Hemostatic Agent

Treatment:

Other: No Hemostatic Agent