Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

Overview

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.

Full Title of Study: “Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 1, 2020

Interventions

  • Device: Hemostatic Agent
    • Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
  • Other: No Hemostatic Agent
    • Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon

Arms, Groups and Cohorts

  • Experimental: Group 1 (Hemostatic Agents Plus +)
  • Active Comparator: Group 2 (Hemostatic Agents Negative -)
    • No Hemostatic Agent

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Total number of major bleeding complications
    • Time Frame: 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
    • Time Frame: up to 6 months
    • Safety monitoring parameters including stroke, death, cardiac arrest, myocardial infarction and urine leak
  • Operating room parameters
    • Time Frame: 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
    • Time Frame: up to 6 months
    • Total length of all inpatient hospital stay over 30 days measured in days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arieh Shalhav, MD, Principal Investigator, University of Chicago
  • Overall Contact(s)
    • Arieh Shalhav, MD, 773-834-9889

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