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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
178
Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon
The University of Chicago
Chicago, Illinois, United States
An absolute change in hemoglobin
The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively.
Time frame: up to 6 months
Total number of major bleeding complications
Major complications are blood loss requiring transfusion of packed red blood cells, reoperation and endovascular ablation
Time frame: up to 6 months
Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety monitoring parameters including stroke, death, cardiac arrest, myocardial infarction and urine leak
Time frame: up to 6 months
Operating room parameters
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
Time frame: up to 6 months
Patients with a hospital stay over 30 days
Total length of all inpatient hospital stay over 30 days measured in days
Time frame: up to 6 months
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