Prevention of Lymphoceles After Robotic PLND

Completed · Not applicable

Conditions studied: Lymphoceles, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02035475

Run by

OhioHealth

People needed

120

Starts

2014-08-01

Expected to finish

2014-12-01

Last updated by the study team

2016-11-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Candidate scheduled to undergo robotic prostatectomy surgery with PLND

You may not qualify if…

• Age < 18
• Unable to give informed consent
• Non-English speaking
• Not a candidate for robotic surgery for any reason

Where it is running

• Dublin Methodist Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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