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Lymphocele After Surgical ProcedureNCT03567525

Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

A study testing lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels and Standard surgical approach in people with Lymphocele After Surgical Procedure, run by Hartford Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Lymphocele After Surgical Procedure
What is being tested?
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels and Standard surgical approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
1 siteUnited States
Study dates
14 Sep 2018to 8 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hartford Hospital

    Hartford, Connecticut, 06102

Other trials in United States

About this study

Official title: The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy

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.

Read more

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.
Being tested
lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels, Standard surgical approach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vesselsProcedure or surgery

    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

  • Standard surgical approachProcedure or surgery

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

Study groups in NCT03567525
Study groupRoleWhat they receive
Standard surgical approachActive comparatorstandard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels
Receives: Procedure: Standard surgical approach
Experimental approachExperimentallymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
Receives: Procedure: lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lymphocele formation

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2018
  2. Study start14 Sep 2018
  3. Primary completion11 Jan 2022
  4. Study completion8 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03567525
Sponsor's protocol ID
HHC-2018-0115
Status last verified
Aug 2022
First submitted
13 Jun 2018
Last updated
31 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels and Standard surgical approach in people with Lymphocele After Surgical Procedure, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lymphocele formation (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.

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