Trial Outcomes & Findings for Prevention of Lymphoceles After Robotic PLND (NCT NCT02035475)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

4 months

Results posted on

2016-11-15

Participant Flow

Prostatectomy patients were recruited from a single robotic urologists office, between 1/15/13 and 5/12/14. The final followup visit was completed on 12/18/14.

Participants must be eligible for robotic procedures.

Participant milestones

Participant milestones
Measure	Intuitive Vessel Sealer Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Overall Study STARTED	120
Overall Study COMPLETED	114
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Intuitive Vessel Sealer Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Equipment Error	1

Baseline Characteristics

Prevention of Lymphoceles After Robotic PLND

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intuitive Vessel Sealer n=114 Participants Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Age, Continuous	62.2 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Lymphoceles were identified by CT scan at 3 months post surgery.

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.

Outcome measures

Outcome measures
Measure	EndoWrist 1 Vessel Sealer n=114 Participants Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side.	Fenestrated Maryland BiPolar Instrument n=114 Participants The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.
Incidence of Lymphoceles Lymphoceles	10 participants	12 participants
Incidence of Lymphoceles No Lymphoceles	104 participants	102 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	EndoWrist 1 Vessel Sealer n=114 Participants Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side.	Fenestrated Maryland BiPolar Instrument The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.
Surgical Complications	3 participants	—

Adverse Events

Study Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Participants n=114 participants at risk Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
General disorders Rehospitalization	0.88% 1/114 • Number of events 1
Blood and lymphatic system disorders Bilateral Pulmonary Embolisms	0.88% 1/114 • Number of events 1
General disorders Prolonged existing hospitalization	1.8% 2/114 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ronney Abaza

OhioHealth

Phone: 614-544-8104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place