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.
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.
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:
- 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.
- Conditions
- Lymphocele After Surgical Procedure
- 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 group | Role | What they receive |
|---|---|---|
| Standard surgical approach | Active comparator | standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels Receives: Procedure: Standard surgical approach |
| Experimental approach | Experimental | lymph 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.
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.
- First posted25 Jun 2018
- Study start14 Sep 2018
- Primary completion11 Jan 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocele After Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03567525
- Acronym / sponsor ID
- HHC-2018-0115
- Conditions
- Lymphocele After Surgical Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard surgical approach | Active comparator | Procedure: Standard surgical approachstandard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels |
| Experimental approach | Experimental | Procedure: lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vesselslymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with prior prostate irradiation and peri-aortic lymph node dissections will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vesselsAfter 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 | Procedure or surgery | Experimental approach |
| Standard surgical approachAfter pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach | Procedure or surgery | Standard surgical approach |
Primary outcome
Lymphocele formation
Time frame: 3 months
Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.