Kidney Cancer
Conditions
Brief summary
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.
Interventions
DEVICEHemostatic Agent
Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
OTHERNo Hemostatic Agent
Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| An absolute change in hemoglobin | up to 6 months | The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of major bleeding complications | up to 6 months | Major complications are blood loss requiring transfusion of packed red blood cells, reoperation and endovascular ablation |
| Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 6 months | Safety monitoring parameters including stroke, death, cardiac arrest, myocardial infarction and urine leak |
| Operating room parameters | up to 6 months | Operating room parameters including number of sutures used during renorrhaphy and capsular closure, duration of renorrhaphy and patients in group 2 with no hemostatic agents who required HA at the surgeons 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 |
Countries
United States
Outcome results
None listed