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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


N/A
N/A
N/A
Open (Enrolling)
Male
Lymphocele, Prostate Cancer

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Trial Information

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


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.


Inclusion Criteria:



- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Incidence of postoperative lymphocele formation

Outcome Description:

The rate of lymphoceles on each side of the pelvis will be compared. Summary statistics will be reported (mean, standard deviation, and range for the continuous variables and frequency and percentages for the categorical variables). In addition, we will determine interrelationships among specific variables using regression and correlation analyses.

Outcome Time Frame:

3 months after surgery

Safety Issue:

No

Principal Investigator

Ronney Abaza

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-11017

NCT ID:

NCT01644136

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Lymphocele
  • Prostate Cancer
  • Lymphocele
  • Prostatic Neoplasms

Name

Location
The Ohio State University Medical Center, Stress Columbus, Ohio  43210