Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03567525
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital

Brief Summary:

Lymphoceles are a potentially serious complication of radical prostatectomy (RP) with pelvic lymph node dissection. They are associated with abdominal pain, urinary tract symptoms, fever, lower extremity swelling and deep vein thrombosis. They can be severe enough to necessitate intervention in 5% of patients after RRP with PLND, with sequela that could include infection and nerve damage. Studies evaluating strategies to preclude lymphocele formation after RP have included comparisons of the use of titanium clips vs bipolar coagulation to seal lymphatic vessels during pelvic lymph node dissection. In a recent prospective randomized trial comparing these approaches, no differences were observed in the rates of lymphocele formation as detected by ultrasound. There is a need to continue to test potential strategies to minimize the formation of lymphoceles after RRP.

Creation of a peritoneal iliac flap is one approach has potential towards this end. At the Lahey Hospital and Medical Center in Burlington, MA surgeons routinely fold the bladder into a peritoneal flap to overlay the area of extended lymphadenectomy. It is thought that this method prevents the formation of lymphoceles because the flap creates a window, which allows drainage of the lymph fluid into the peritoneal cavity to be reabsorbed. While the Lahey study supports the safety and effectiveness of the peritoneal flap approach, the procedure has never been evaluated through a randomized prospective trial and the practice is certainly not standard of care. We therefore propose a randomized, prospective clinical trial to be conducted in the Hartford Hospital Urology Department to examine the effectiveness of a peritoneal iliac flap on the formation of lymphoceles after RRP with pelvic lymph node dissection.

Hypotheses:

  1. We hypothesize that, at 3 months after RP, rates of lymphocele formation (symptomatic and asymptomatic lymphoceles) will be significantly lower in patients who have pelvic lymph node dissection using the peritoneal iliac flap approach than in patients who have pelvic lymph node dissection using the standard approach.
  2. Lymphoceles are often associated with lower urinary tract symptoms. We hypothesize that, after RP, severity of urinary bother symptoms and urinary incontinence will be significantly lower at each measurement period for patients who had pelvic lymph node dissection using the peritoneal iliac flap approach relative to patients who had pelvic lymph node dissection using the standard approach.

Condition or disease Intervention/treatment Phase
Lymphocele After Surgical Procedure Procedure: lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels Procedure: Standard surgical approach Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Neither the patient nor the surgeon (who is also the investigator) will know to which arm patients are randomized (standard surgical approach) or experimental approach
Primary Purpose: Prevention
Official Title: The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 30, 2020

Arm Intervention/treatment
Active Comparator: Standard surgical approach
standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels
Procedure: Standard surgical approach
After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach

Experimental: Experimental approach
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
Procedure: lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
After pelvic lymph node dissection, lymphatic vessels will be sealed by formation of a peritoneal iliac flap in which the bladder in folded over the area of lymph node dissection




Primary Outcome Measures :
  1. Lymphocele formation [ Time Frame: 3 months ]
    Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled to undergo robotic assisted radical prostatectomy with pelvic lymph node dissection for prostate cancer at Hartford Hospital.
  • diagnosed with biopsy-proven prostate cancer, with intermediate or high risk features per D'Amico risk stratification
  • ability to give informed consent to participate in the study

Exclusion Criteria:

  • Patients with prior prostate irradiation and peri-aortic lymph node dissections will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567525


Contacts
Layout table for location contacts
Contact: Joseph Wagner, MD 8609478500 Joseph.Wagner@hhchealth.org

Locations
Layout table for location information
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Joseph Wagner, MD         
Sponsors and Collaborators
Hartford Hospital

Layout table for additonal information
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT03567525     History of Changes
Other Study ID Numbers: HHC-2018-0115
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphocele
Cysts
Neoplasms
Lymphatic Diseases