Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement 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.

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 exclusion criteria

Exclusion Criteria:

- Non-compliance

- Prior radiotherapy to the pelvis or prostate

- Prior extensive pelvic surgery such as low anterior reception, abdomino-perineal
resection, or proctocolectomy continent stool pouch, or any other extensive
abdomino-pelvic surgery that would render the patient high-rick for complications as
deemed by the surgeon

- Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal
saline at the end of surgery

- Intra-operative injuries (for example: rectal injury)

- Inadequate hemostasis