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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01613651
First received: June 5, 2012
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Perioperative/Postoperative Complications
Prostate Cancer
Procedure: robot-assisted laparoscopic surgery
Other: questionnaire administration
Other: intraoperative complication management/prevention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0) [ Time Frame: Within 90 days from prostatectomy ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Within 90 days post prostatectomy ] [ Designated as safety issue: Yes ]
    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.

  • Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Within 90 days from prostatectomy ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 312
Study Start Date: August 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (RALP)
Patients undergo RALP.
Procedure: robot-assisted laparoscopic surgery
Undergo RALP
Other: questionnaire administration
Ancillary studies
Experimental: Arm II (RALP and placement of pelvic drain)
Patients undergo RALP and placement of pelvic drain.
Procedure: robot-assisted laparoscopic surgery
Undergo RALP
Other: questionnaire administration
Ancillary studies
Other: intraoperative complication management/prevention
Undergo placement of pelvic drain

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613651

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Jonathan Yamzon    800-826-4673    jyamzon@coh.org   
Principal Investigator: Jonathan Yamzon         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Jonathan Yamzon City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01613651     History of Changes
Other Study ID Numbers: 11113, NCI-2012-00558
Study First Received: June 5, 2012
Last Updated: May 30, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Postoperative Complications
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014