Prostate Cancer Clinical Trial
Official title:
A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer
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.
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