Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

NCT03567525 | Completed

• 1 other identifier: HHC-2018-0115
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Lymphocele formation

  Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery

  3 months

Study Arms (2)

Standard surgical approach

ACTIVE COMPARATOR

standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels

Procedure: Standard surgical approach

Experimental approach

EXPERIMENTAL

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

Interventions

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

Experimental approach

Standard surgical approach PROCEDURE

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

Standard surgical approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 25, 2018
• Study Start: September 14, 2018
• Primary Completion: January 11, 2022
• Study Completion: July 8, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)