Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00558 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.
PRIMARY OBJECTIVES:
I. To determine if eliminating placement of a pelvic drain in patients during robotic assisted laparoscopic prostatectomy (RALP) increases incidence of early postoperative adverse events occurring within 90 days from prostatectomy, compared to patients who have a pelvic drain placed during RALP.
SECONDARY OBJECTIVES:
I. To determine the incidence of early postoperative adverse events in patients with and without a pelvic drain when adjustments to confounders associated with these events are made (confounders: demographic, surgical and pathologic; age, body mass index [BMI], pathologic stage, Gleason sum, extent of lymph node dissection).
II. To report peri-operative and postoperative outcomes, including but not limited to, length of hospital stay, re-admissions, continence, potency and incidence of medical interventions for patients with and without pelvic drain.
III. To compare early postoperative adverse event rates between patients with and without a pelvic drain in patients who had extended pelvic lymph node dissection during RALP.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo RALP.
ARM II: Patients undergo RALP and placement of pelvic drain.
After completion of treatment, patients are followed up at 1 week and then 1, 3, 6, 9, and 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (RALP) | Experimental | Patients undergo RALP. |
|
| Arm II (RALP and placement of pelvic drain) | Experimental | Patients undergo RALP and placement of pelvic drain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot-assisted laparoscopic surgery | Procedure | Undergo RALP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0) | The observed rate of adverse events among patients on the two arms of the study will be compared using a one-sided non-inferiority test with the intent to rule out a 10% or greater difference in postoperative adverse event rates. | Within 90 days from prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early postoperative adverse events in patients with and without pelvic drain with adjustments applied to confounders associated with these events according to CTCAE 4.0 | Further analysis will be conducted using multivariate logistic regression, to determine whether the odds of early postoperative adverse events are significantly different for patients in different study arms, once they have controlled for confounding prognostic factors, such as age, BMI, pathologic stage, Gleason sum, and lymph node dissection template. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Yamzon | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| questionnaire administration | Other | Ancillary studies |
|
| intraoperative complication management/prevention | Other | Undergo placement of pelvic drain |
|
| Within 90 days post prostatectomy |
| Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency | Survival analysis will be used to determine if there is any significant difference between patients on two arms of the study with respect to time to continence or potency. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test. | Up to 12 months |
| Incidence of early postoperative adverse events from prostatectomy in patients with and without a pelvic drain who had an extended pelvic lymph node dissection during RALP according to CTCAE 4.0 | Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test. | Within 90 days from prostatectomy |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided