ACTIVE_NOT_RECRUITING

Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-01-01

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04120805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Arieh Shalhav, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

The University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Arieh Shalhav, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-01-01

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2016-01-01

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

Kidney Cancer