Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer
NCT ID: NCT01644136
Last Updated: 2018-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
99 participants
INTERVENTIONAL
2011-07-14
2014-05-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
robot-assisted laparoscopic surgery
Undergo standard robotic assisted laparoscopic prostatectomy
regional lymph node dissection
Undergo pelvic lymph node dissection
microsphere-mediated lymphocele prevention
Undergo microsphere-mediated lymphocele prevention
Interventions
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robot-assisted laparoscopic surgery
Undergo standard robotic assisted laparoscopic prostatectomy
regional lymph node dissection
Undergo pelvic lymph node dissection
microsphere-mediated lymphocele prevention
Undergo microsphere-mediated lymphocele prevention
Eligibility Criteria
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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
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ronney Abaza, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Related Links
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Jamesline
Other Identifiers
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NCI-2012-00918
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-11017
Identifier Type: -
Identifier Source: org_study_id
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