Prevention of Lymphoceles After Robotic PLND
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | December 2014 |
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
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.
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.
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.
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
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