Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy

University of Chicago1 site in 1 country178 target enrollmentJanuary 1, 2016

ConditionsKidney Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Cancer
Sponsor: University of Chicago
Enrollment: 178
Locations: 1
Primary Endpoint: An absolute change in hemoglobin
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2016

End Date

March 1, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

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 INR greater than 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.

Outcomes

Primary Outcomes

An absolute change in hemoglobin

Time Frame: 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 Outcomes

Patients with a hospital stay over 30 days(up to 6 months)
Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 6 months)
Total number of major bleeding complications(up to 6 months)
Operating room parameters(up to 6 months)