Clinical Trial 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.
