Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement in Reducing Adverse Events After Surgery in Patients With Prostate Cancer

City of Hope Medical Center191 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

191

Conditions

Perioperative/Postoperative Complications Prostate Cancer

Interventions

robot-assisted laparoscopic surgeryPROCEDURE

Undergo RALP

questionnaire administrationOTHER

Ancillary studies

intraoperative complication management/preventionOTHER

Undergo placement of pelvic drain

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Within 90 days from prostatectomy

Secondary Outcomes

Incidence of early postoperative adverse events in patients with and without pelvic drain with adjustments applied to confounders associated with these events according to CTCAE 4.0

Further analysis will be conducted using multivariate logistic regression, to determine whether the odds of early postoperative adverse events are significantly different for patients in different study arms, once they have controlled for confounding prognostic factors, such as age, BMI, pathologic stage, Gleason sum, and lymph node dissection template. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test.

Time frame: Within 90 days post prostatectomy

Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency

Survival analysis will be used to determine if there is any significant difference between patients on two arms of the study with respect to time to continence or potency. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test.

Time frame: Up to 12 months

Incidence of early postoperative adverse events from prostatectomy in patients with and without a pelvic drain who had an extended pelvic lymph node dissection during RALP according to CTCAE 4.0

Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test.

Data from ClinicalTrials.gov

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