NCT01644136

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphocele
• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	robot-assisted laparoscopic surgery	Undergo standard robotic assisted laparoscopic prostatectomy
PROCEDURE	regional lymph node dissection	Undergo pelvic lymph node dissection
DEVICE	microsphere-mediated lymphocele prevention	Undergo microsphere-mediated lymphocele prevention

Timeline

• Start date: 2011-07-14
• Primary completion: 2014-05-06
• Completion: 2014-05-06
• First posted: 2012-07-18
• Last updated: 2018-06-28

Locations

1 site across 1 country: United States