COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Lymphoceles After Robotic PLND (PLND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035475
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
Intuitive Surgical
Information provided by (Responsible Party):
Ronney Abaza, OhioHealth

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Lymphoceles Prostate Cancer Device: Intuitive Vessel Sealer Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Intuitive Vessel Sealer
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
 Device: Intuitive Vessel Sealer
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Other Name: EndoWrist One Vessel Sealer
Active Comparator: Maryland Bipolar Cautery
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
 Device: Intuitive Vessel Sealer
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Other Name: EndoWrist One Vessel Sealer


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Lymphoceles [ Time Frame: 4 months ]
    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.


Secondary Outcome Measures :
  1. Surgical Complications [ Time Frame: 4 months ]
    Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035475


Locations
Layout table for location information
United States, Ohio
Dublin Methodist Hospital
Columbus, Ohio, United States, 43016
Sponsors and Collaborators
OhioHealth
Intuitive Surgical
Investigators
Layout table for investigator information
Principal Investigator: Ronney Abaza, MD, FACS OhioHealth
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ronney Abaza, Medical Director Robotic Surgery, OhioHealth
ClinicalTrials.gov Identifier: NCT02035475    
Other Study ID Numbers: OH1-13-00471
First Posted: January 14, 2014    Key Record Dates
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2016
Last Verified: April 2016
Keywords provided by Ronney Abaza, OhioHealth:
Prevention
Pelvic Lymph Node Dissection
Lymphoceles
Prostate Malignancies
 daVinci
Vessel Sealer
EndoWrist One
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphocele
Neoplasms
Cysts
Lymphatic Diseases