Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT03567525|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 21, 2019
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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphocele After Surgical Procedure||Procedure: lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels Procedure: Standard surgical approach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||262 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||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|
|Official Title:||The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy|
|Actual Study Start Date :||September 14, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 30, 2020|
Active Comparator: Standard surgical approach
standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels
Procedure: Standard surgical approach
After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach
Experimental: Experimental approach
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
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
- Lymphocele formation [ Time Frame: 3 months ]Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567525
|Contact: Joseph Wagner, MD||8609478500||Joseph.Wagner@hhchealth.org|
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|Contact: Joseph Wagner, MD|