Lymphocele, Prostate Cancer
Conditions
Brief summary
This study is being performed to investigate if the application of Arista absorbable hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. These fluid collections can become symptomatic in some patients. Arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after surgery
Detailed description
PRIMARY OBJECTIVES: I. To determine whether, if applied to the lymph node basins after pelvic lymph node dissection, Arista could potentially reduce the formation of lymphoceles and consequently the need for secondary interventions. OUTLINE: Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis. After completion of study treatment, patients are followed up at 3 months.
Interventions
PROCEDURErobot-assisted laparoscopic surgery
Undergo standard robotic assisted laparoscopic prostatectomy
PROCEDUREregional lymph node dissection
Undergo pelvic lymph node dissection
DEVICEmicrosphere-mediated lymphocele prevention
Undergo microsphere-mediated lymphocele prevention
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Male patients * Patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center by Dr. Ronney Abaza
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative lymphocele formation | 3 months after surgery | The rate of lymphoceles on each side of the pelvis will be compared. Summary statistics will be reported (mean, standard deviation, and range for the continuous variables and frequency and percentages for the categorical variables). In addition, we will determine interrelationships among specific variables using regression and correlation analyses. |
Countries
United States
Outcome results
None listed