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OpenTrials
Active, Not Recruiting

NCT Number: NCT04120805

Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemostatic Agent

Device

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

No Hemostatic Agent

Other

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Oct 9, 2019
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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