Clinical trial NCT02035475: Prevention of Lymphoceles After Robotic PLND
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoceles
Prostate Cancer
Keywords: Prevention
Pelvic Lymph Node Dissection
Lymphoceles
Prostate Malignancies
daVinci
Vessel Sealer
EndoWrist One
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2014-01-14
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Incidence of Lymphoceles
timeFrame: 4 months
Secondary outcomes:
measure: Surgical Complications
timeFrame: 4 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Dublin Methodist Hospital
state: Ohio
Study officials:
affiliation: OhioHealth
name: Ronney Abaza, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abaza R, Henderson SJ, Martinez O. Robotic Vessel Sealer Device for Lymphocele Prevention After Pelvic Lymphadenectomy: Results of a Randomized Trial. J Laparoendosc Adv Surg Tech A. 2022 Jul;32(7):721-726. doi: 10.1089/lap.2021.0531. Epub 2021 Oct 22.