Monday, October 26, 2026 · Daily editionET --:--:--

Finished

Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

NCT03567525 · Hartford Hospital · Updated 31 Aug 2022

What is being tested
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels; Standard surgical approach
For
Lymphocele After Surgical Procedure
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 225 people. The full rules are on the registry page.
Where
United States
When
Starts or started 14 Sept 2018, ends 8 July 2022. Registered 25 June 2018.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT03567525

Sites

  • Hartford HospitalHartford, Connecticut, United States