Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy
Condition: Lymphocele After Surgical Procedure
MeSH terms: Lymphocele
Study type: Interventional

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.
    


Intervention name(s): lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels; Standard surgical approach
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention