Lymphoceles Following Pelvic Lymph Node Dissection
Conditions
Keywords
lymphocele, pelvic lymph node dissection, robotic assisted radical prostatectomy, PLND, RARP, prostatectomy, Patel
Brief summary
This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.
Detailed description
Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.
Interventions
DEVICEJ-Plasma
Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.
Sponsors
AdventHealth
Apyx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Primary diagnosis of Prostate Cancer (ICD-10:C61) 2. Prostate Specific Antigen (PSA) level =/\> 10ng/mL 3. Gleason score =/\> 7 4. Planned Elective Robotic Assisted Radical Prostatectomy with planned pelvic lymph node dissection. 5. Willing and able to return to clinic for standard of care abdominal ultrasound within 12 weeks post operatively. 6. Able to provide informed consent
Exclusion criteria
Must answer no to all: 1. Patient is unwilling or unable to sign or understand informed consent 2. Patient resides outside of the United States 3. Performance of Lymph node dissection was aborted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of Lymphocele Formation | 12 weeks | The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| J-Plasma Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.
J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | J-Plasma |
|---|---|
| Age, Continuous | 63.28 Years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Pre-Operative Biopsy Gleason | 7.45 units on a scale (Scale 2 - 10) STANDARD_DEVIATION 0.78 |
| Pre-Op Prostate-Specific Antigen (PSA) | 7.97 ng/mL STANDARD_DEVIATION 5.23 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Number of Participants With Incidence of Lymphocele Formation
The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| J-Plasma | Number of Participants With Incidence of Lymphocele Formation | 1 Participants |