Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy
Primary Purpose
Lymphocele After Surgical Procedure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
Standard surgical approach
Sponsored by
About this trial
This is an interventional prevention trial for Lymphocele After Surgical Procedure
Eligibility 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
Sites / Locations
- Hartford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard surgical approach
Experimental approach
Arm Description
standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
Outcomes
Primary Outcome Measures
Lymphocele formation
Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03567525
Brief Title
Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy
Official Title
The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocele After Surgical Procedure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard surgical approach
Arm Type
Active Comparator
Arm Description
standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels
Arm Title
Experimental approach
Arm Type
Experimental
Arm Description
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
Intervention Type
Procedure
Intervention Name(s)
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard surgical approach
Intervention Description
After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach
Primary Outcome Measure Information:
Title
Lymphocele formation
Description
Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy
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