Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

NCT ID: NCT03567525

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2022-07-08

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.

Conditions

Lymphocele After Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Standard surgical approach

standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels

Group Type: ACTIVE_COMPARATOR

Standard surgical approach

Intervention Type: PROCEDURE

After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach

Experimental approach

lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels

Group Type: EXPERIMENTAL

lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Standard surgical approach

After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

HHC-2018-0115

Identifier Type: -

Identifier Source: org_study_id