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
  Purpose

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


Condition Intervention
Lymphocele
Prostate Cancer
Procedure: robot-assisted laparoscopic surgery
Procedure: regional lymph node dissection
Device: microsphere-mediated lymphocele prevention

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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644136

Contacts
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

Locations
United States, Ohio
The Ohio State University Medical Center, Stress Recruiting
Columbus, Ohio, United States, 43210
Contact: Ronney Abaza    614-293-0981    Ronney.Abaza@osumc.edu   
Principal Investigator: Ronney Abaza         
Sponsors and Collaborators
Ronney Abaza
Investigators
Principal Investigator: Ronney Abaza Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Ronney Abaza, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01644136     History of Changes
Other Study ID Numbers: OSU-11017, NCI-2012-00918
Study First Received: July 16, 2012
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphocele
Prostatic Neoplasms
Cysts
Neoplasms
Lymphatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014