Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

NCT ID: NCT04120805

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2026-03-01

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group 1 (Hemostatic Agents Plus +)

Group Type: EXPERIMENTAL

Hemostatic Agent

Intervention Type: DEVICE

Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon

Group 2 (Hemostatic Agents Negative -)

No Hemostatic Agent

Group Type: ACTIVE_COMPARATOR

No Hemostatic Agent

Intervention Type: OTHER

Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon

Interventions

Hemostatic Agent

Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon

Intervention Type: DEVICE

No Hemostatic Agent

Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arieh Shalhav, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB15-0519

Identifier Type: -

Identifier Source: org_study_id