Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy

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.

Study Overview

• Status: Completed
• Conditions: Lymphocele After Surgical Procedure
• Intervention / Treatment: Procedure: Standard surgical approach; Procedure: lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphocele formation	Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery	3 months

Collaborators and Investigators

• Sponsor: Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): January 11, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Cysts; Lymphocele
• Other Study ID Numbers: HHC-2018-0115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No