Prevention of Lymphoceles After Robotic PLND

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lymphoceles, Prostate Cancer

Intervention / Treatment
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* Device: Intuitive Vessel Sealer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Candidate scheduled to undergo robotic prostatectomy surgery with PLND Exclusion Criteria: Age < 18 Unable to give informed consent Non-English speaking Not a candidate for robotic surgery for any reason

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intuitive Vessel Sealer<br>Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. | Device: Intuitive Vessel Sealer<br>* Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.<br>* Other names: EndoWrist One Vessel Sealer;|
| Active Comparator: Maryland Bipolar Cautery<br>Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. | Device: Intuitive Vessel Sealer<br>* Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.<br>* Other names: EndoWrist One Vessel Sealer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Lymphoceles | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Complications | Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include no complications (0), minor complications (1), and major complications (2). | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Pelvic Lymph Node Dissection, Lymphoceles, Prostate Malignancies, daVinci, Vessel Sealer, EndoWrist One