Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Clinical Trial for the Prevention of Lymphoceles After Robotic Pelvic Lymph Node Dissections for Prostate Malignancies Using the da Vinci® EndoWrist® One
Brief Summary:
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. Their use in this study will be to perform tissue transection during PLND such that the intended use is within the FDA-approved domain for this instrument. Investigators intend to identify whether its use for PLND reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during PLND. Because the instrument is new and has been FDA approved for less than one year, there is no published literature regarding its use to date.
Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. Investigators propose a total sample size of 120 patients.