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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01644136
Collaborator
(none)
99
Enrollment
1
Location
1
Arm
33.7
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: robot-assisted laparoscopic surgery
  • Procedure: regional lymph node dissection
  • Device: microsphere-mediated lymphocele prevention
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Actual Study Start Date :
Jul 14, 2011
Actual Primary Completion Date :
May 6, 2014
Actual Study Completion Date :
May 6, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Incidence of postoperative lymphocele formation [3 months after surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ohio State University Medical Center Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Ronney Abaza, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01644136
Other Study ID Numbers:
  • OSU-11017
  • NCI-2012-00918
First Posted:
Jul 18, 2012
Last Update Posted:
Jun 28, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Prostatic Neoplasms
Lymphocele

Study Results

No Results Posted as of Jun 28, 2018