Prevention of Lymphoceles After Robotic PLND (PLND)
Primary Purpose
Lymphoceles, Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intuitive Vessel Sealer
Sponsored by
About this trial
This is an interventional prevention trial for Lymphoceles focused on measuring Prevention, Pelvic Lymph Node Dissection, Lymphoceles, Prostate Malignancies, daVinci, Vessel Sealer, EndoWrist One
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
Sites / Locations
- Dublin Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intuitive Vessel Sealer
Maryland Bipolar Cautery
Arm Description
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Outcomes
Primary Outcome Measures
Incidence of Lymphoceles
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
Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2).
Full Information
NCT ID
NCT02035475
First Posted
January 10, 2014
Last Updated
September 26, 2016
Sponsor
OhioHealth
Collaborators
Intuitive Surgical
1. Study Identification
Unique Protocol Identification Number
NCT02035475
Brief Title
Prevention of Lymphoceles After Robotic PLND
Acronym
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OhioHealth
Collaborators
Intuitive Surgical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoceles, Prostate Cancer
Keywords
Prevention, Pelvic Lymph Node Dissection, Lymphoceles, Prostate Malignancies, daVinci, Vessel Sealer, EndoWrist One
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intuitive Vessel Sealer
Arm Type
Active Comparator
Arm Description
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Arm Title
Maryland Bipolar Cautery
Arm Type
Active Comparator
Arm Description
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Intervention Type
Device
Intervention Name(s)
Intuitive Vessel Sealer
Other Intervention Name(s)
EndoWrist One Vessel Sealer
Intervention Description
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Primary Outcome Measure Information:
Title
Incidence of Lymphoceles
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Surgical Complications
Description
Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2).
Time Frame
4 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronney Abaza, MD, FACS
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dublin Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34677080
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.
Results Reference
derived
Learn more about this trial
Prevention of Lymphoceles After Robotic PLND
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