Prostate Cancer Clinical Trial

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

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

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Male patients
Patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center by Dr. Ronney Abaza

Study is for people with:

Prostate Cancer

Estimated Enrollment:

99

Study ID:

NCT01644136

Recruitment Status:

Terminated

Sponsor:

Ohio State University Comprehensive Cancer Center

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There is 1 Location for this study

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The Ohio State University Medical Center
Columbus Ohio, 43210, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

99

Study ID:

NCT01644136

Recruitment Status:

Terminated

Sponsor:


Ohio State University Comprehensive Cancer Center

How clear is this clinincal trial information?

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