Prevention of Lymphoceles After Robotic PLND

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Intuitive Surgical
Information provided by (Responsible Party):
Ronney Abaza, OhioHealth
ClinicalTrials.gov Identifier:
NCT02035475
First received: January 10, 2014
Last updated: October 24, 2014
Last verified: July 2014
  Purpose

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 Intervention
Lymphoceles
Prostate Cancer
Device: Intuitive Vessel Sealer

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by OhioHealth:

Primary Outcome Measures:
  • Incidence of lymphoceles [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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:
  • Surgical complications [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2).


Estimated Enrollment: 120
Study Start Date: August 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035475

Locations
United States, Ohio
Dublin Methodist Hospital
Columbus, Ohio, United States, 43016
Sponsors and Collaborators
OhioHealth
Intuitive Surgical
Investigators
Principal Investigator: Ronney Abaza, MD, FACS OhioHealth
  More Information

No publications provided

Responsible Party: Ronney Abaza, Medical Director Robotic Surgery, OhioHealth
ClinicalTrials.gov Identifier: NCT02035475     History of Changes
Other Study ID Numbers: OH1-13-00471
Study First Received: January 10, 2014
Last Updated: October 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by OhioHealth:
Prevention
Pelvic Lymph Node Dissection
Lymphoceles
Prostate Malignancies
daVinci
Vessel Sealer
EndoWrist One

Additional relevant MeSH terms:
Lymphocele
Prostatic Neoplasms
Cysts
Genital Diseases, Male
Genital Neoplasms, Male
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014