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

NCT01644136 | Terminated DMC

• 2 other identifiers: OSU-11017NCI-2012-00918
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphocele; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative lymphocele formation

  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.

  3 months after surgery

Study Arms (1)

Supportive care (microsphere-mediated lymphocele prevention)

EXPERIMENTAL

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; Procedure: regional lymph node dissection; Device: microsphere-mediated lymphocele prevention

Interventions

robot-assisted laparoscopic surgery PROCEDURE

Undergo standard robotic assisted laparoscopic prostatectomy

Supportive care (microsphere-mediated lymphocele prevention)

regional lymph node dissection PROCEDURE

Undergo pelvic lymph node dissection

Supportive care (microsphere-mediated lymphocele prevention)

microsphere-mediated lymphocele prevention DEVICE

Undergo microsphere-mediated lymphocele prevention

Supportive care (microsphere-mediated lymphocele prevention)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Lymphocele; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ronney Abaza, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: July 14, 2011
• Primary Completion: May 6, 2014
• Study Completion: May 6, 2014
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

US (1)