Spots Global Cancer Trial Database for Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer

Official Title: A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection

Study ID: NCT01644136

Conditions

Lymphocele

Prostate Cancer

Interventions

robot-assisted laparoscopic surgery

regional lymph node dissection

microsphere-mediated lymphocele prevention

Study Description

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.