A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer
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.
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
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
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
City of Hope Medical Center
United States: Federal Government
|City of Hope Medical Center||Duarte, California 91010|