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

NCT01644136 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2018-06-28

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Ronney Abaza, MD · Ohio State University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-14
Primary Completion
2014-05-06
Completion
2014-05-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644136 on ClinicalTrials.gov