Goal is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy.
The goal of this clinical trial is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy. The main question is if it could improve patients' quality of life and infection risk post-surgery. It would also help to decrease emergency room visits as well as additional procedures. Researchers will compare those who receive the ICG and those who do not. Patients will be randomized into the ICG arm versus no ICG arm after pelvic lymphadenectomy is done.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Patient will have a green dye (ICG) injected into the lymph node to better visualize non-sealed leaks in order to pre-emptively seal any lymphatic leaks.
No ICG injection
Robotic assisted prostatectomy with pelvic lymph node dissection
Drain output <100 mL
A sample of 12 recent patients receiving the current standard procedure had a mean drain volume for the first 24 hours of 218 mL and standard deviation of 102. With a hoped-for reduction to \<100 mL/ 24 hr mean in the treatment arm, there would be 99% power to detect a difference, and 80% power to detect a difference of 57 mL between treatment and control arms. Given the small sample used for this power estimate, we believe that it is appropriate to power for a range of potential standard deviations and potential differences.
Time frame: 2 weeks
Lymphocele formation
Any lymphocele formation will be logged; any lymphocele proven by imaging
Time frame: 4 weeks
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