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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00918 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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PI left institution
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot-assisted laparoscopic surgery | Procedure | Undergo standard robotic assisted laparoscopic prostatectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronney Abaza, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Jamesline | View source |
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| regional lymph node dissection | Procedure | Undergo pelvic lymph node dissection |
|
| microsphere-mediated lymphocele prevention | Device | Undergo microsphere-mediated lymphocele prevention |
|
| ID | Term |
|---|---|
| D008210 | Lymphocele |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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