Perioperative/Postoperative Complications, Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURErobot-assisted laparoscopic surgery
Undergo RALP
OTHERquestionnaire administration
Ancillary studies
Undergo placement of pelvic drain
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center * Written informed consent obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services * Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0) | Within 90 days from prostatectomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Within 90 days post prostatectomy | 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. |
| Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency | Up to 12 months | 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. |
| 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 | Within 90 days from prostatectomy | 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. |
Countries
United States
Outcome results
None listed