A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Incidence of postoperative lymphocele formation
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.
3 months after surgery
Ohio State University
United States: Institutional Review Board
|The Ohio State University Medical Center, Stress||Columbus, Ohio 43210|