Lymphoceles, Prostate Cancer
Conditions
Keywords
Prevention, Pelvic Lymph Node Dissection, Lymphoceles, Prostate Malignancies, daVinci, Vessel Sealer, EndoWrist One
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.
Interventions
DEVICEIntuitive Vessel Sealer
Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Sponsors
Intuitive Surgical
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Lymphoceles | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complications | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Participants must be eligible for robotic procedures.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 114 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment Error | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Intuitive Vessel Sealer |
|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 114 |
| serious Total, serious adverse events | 3 / 114 |
Outcome results
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.
Time frame: 4 months
Population: Lymphoceles were identified by CT scan at 3 months post surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EndoWrist 1 Vessel Sealer | Incidence of Lymphoceles | Lymphoceles | 10 participants |
| EndoWrist 1 Vessel Sealer | Incidence of Lymphoceles | No Lymphoceles | 104 participants |
| Fenestrated Maryland BiPolar Instrument | Incidence of Lymphoceles | Lymphoceles | 12 participants |
| Fenestrated Maryland BiPolar Instrument | Incidence of Lymphoceles | No Lymphoceles | 102 participants |
Comparison: The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.p-value: 0.412McNemar
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).
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoWrist 1 Vessel Sealer | Surgical Complications | 3 participants |