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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Perioperative/Postoperative Complications, Prostate Cancer

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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 CenterDuarte, California  91010