A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer
18 Years
N/A
Male
Perioperative/Postoperative Complications, Prostate Cancer
Trial Information
A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0)
Outcome Description:
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.
Outcome Time Frame:
Within 90 days from prostatectomy
Safety Issue:
Yes
Principal Investigator
Jonathan Yamzon
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Federal Government
Study ID:
11113
NCT ID:
NCT01613651
Start Date:
August 2012
Completion Date:
Related Keywords:
- Perioperative/Postoperative Complications
- Prostate Cancer
- Postoperative Complications
- Prostatic Neoplasms
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
