N/A
Completed N=120
Prevention of Lymphoceles After Robotic PLND
Lymphoceles · Prostate Cancer
Source: ClinicalTrials.gov NCT02035475 ↗
Enrolled (actual)
120
Serious AEs
2.6%
Results posted
Nov 2016
Primary outcomePrimary: Incidence of Lymphoceles — 10; 12; 104; 102 participants — p=0.412
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Lymphoceles |
10; 12; 104; 102 | 0.412 |
| SECONDARY Surgical Complications |
3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02035475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.