Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Lymphocele

Cysts

Lymphatic Diseases

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Intuitive Vessel Sealer

Ronney Abaza, MD, FACS

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.

Investigators propose a prospective, randomized, single-blinded study of patients diagnosed with pelvic cancer who are electing to undergo robotic surgery with PLND. The patients in our trial will be pelvic cancer patients at risk for lymphocele after PLND. Given the safe nature of the product and the patient's risk for lymphocele after PLND and subsequent potential morbidity, there is justification to give patients the option for inclusion in the study. Investigators intend to determine whether the rate of lymphocele formation after PLND at the time of robotic pelvic cancer surgery can be reduced by using the robotic Vessel Sealer unilaterally for the lymph node dissection. The side of the pelvis of each patient will be randomly selected by Excel's® random number function "RAND()" to receive the Vessel Sealer dissection. Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control and eliminate patient specific confounding variables such as BMI, and surgeon specific factors such as degree and method of hemostasis utilized by each surgeon. In addition, Dr. Abaza will be the only surgeon performing these procedures, eliminating variation in technique between surgeons.

Prevention of Lymphoceles After Robotic PLND

A Pilot Clinical Trial for the Prevention of Lymphoceles After Robotic Pelvic Lymph Node Dissections for Prostate Malignancies Using the da Vinci® EndoWrist® One™ Vessel Sealer

Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis.

Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2).

Intuitive Surgical

OhioHealth

Medical Director Robotic Surgery

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Study Participants

Age, Continuous

Sex: Female, Male

Dr. Ronney Abaza

The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.

Lymphoceles

No Lymphoceles

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side.

EndoWrist 1 Vessel Sealer

The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.

Spots Global Cancer Trial Database for endowrist one