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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Ohio State University Comprehensive Cancer Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ronney Abaza, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01644136
First received: July 16, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted

July 16, 2012
July 16, 2012
July 2011
July 2012   (final data collection date for primary outcome measure)
Incidence of postoperative lymphocele formation [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Not Provided
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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

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Lymphocele
  • Prostate Cancer
  • 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
Experimental: Supportive care (microsphere-mediated lymphocele prevention)
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.
Interventions:
  • Procedure: robot-assisted laparoscopic surgery
  • Procedure: regional lymph node dissection
  • Device: microsphere-mediated lymphocele prevention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
July 2012   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Ronney Abaza, MD 614-293-0981 ronney.abaza@osumc.edu
United States
 
NCT01644136
OSU-11017, NCI-2012-00918
Yes
Ronney Abaza, Ohio State University Comprehensive Cancer Center
Ronney Abaza
Not Provided
Principal Investigator: Ronney Abaza Ohio State University
Ohio State University Comprehensive Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP