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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04120805
Other study ID # IRB15-0519
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date March 1, 2026

Study information

Verified date November 2023
Source University of Chicago
Contact Arieh Shalhav, MD
Phone 773-834-9889
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 178
Est. completion date March 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 6 months
Secondary Total number of major bleeding complications Major complications are blood loss requiring transfusion of packed red blood cells, reoperation and endovascular ablation up to 6 months
Secondary 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 up to 6 months
Secondary 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 up to 6 months
Secondary Patients with a hospital stay over 30 days Total length of all inpatient hospital stay over 30 days measured in days up to 6 months
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