Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer
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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 |
- 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 |
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| 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, 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 | |
| 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 May 22, 2013