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

Not Applicable

Terminated

• Conditions: Lymphocele; Prostate Cancer
• Interventions: Procedure: robot-assisted laparoscopic surgery; Procedure: regional lymph node dissection; Device: microsphere-mediated lymphocele prevention

• Registration Number: NCT01644136
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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

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.

Study Timeline

• Study Start: 2011-07-14
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Primary Completion: 2014-05-06
• Study Completion: 2014-05-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 99

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (microsphere-mediated lymphocele prevention)	robot-assisted laparoscopic surgery	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.
Supportive care (microsphere-mediated lymphocele prevention)	regional lymph node dissection	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.
Supportive care (microsphere-mediated lymphocele prevention)	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States