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A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection
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
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.
Age
All ages
Sex
MALE
Healthy Volunteers
No
The Ohio State University Medical Center
Columbus, Ohio, United States
Start Date
July 14, 2011
Primary Completion Date
May 6, 2014
Completion Date
May 6, 2014
Last Updated
June 28, 2018
99
ACTUAL participants
robot-assisted laparoscopic surgery
PROCEDURE
regional lymph node dissection
PROCEDURE
microsphere-mediated lymphocele prevention
DEVICE
Lead Sponsor
Ohio State University Comprehensive Cancer Center
NCT05691465
NCT04550494
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