Prevention of Lymphoceles After Robotic PLND

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035475
• Other study ID #: OH1-13-00471
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: October 13, 2015
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphocele
• Lymphoceles
• Prostate Cancer

Intervention

Device:
• Intuitive Vessel Sealer
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Locations

Country	Name	City	State
United States	Dublin Methodist Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months	No
Secondary	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).	4 months	No