Prevention of Lymphoceles After Robotic PLND (PLND)

September 26, 2016 updated by: Ronney Abaza, OhioHealth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43016
        • Dublin Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • EndoWrist One Vessel Sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OhioHealth

Collaborators

Intuitive Surgical

Investigators

  • Principal Investigator: Ronney Abaza, MD, FACS, OhioHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (ESTIMATE)

January 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OH1-13-00471

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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