Clinical Trial: Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatecto

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 Summary:

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.

Current Primary Outcome: Incidence of postoperative lymphocele formation [ Time Frame: 3 months after surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: July 16, 2012
Date Started: July 2011
Date Completion:
Last Updated: July 16, 2012
Last Verified: July 2012