Description of an Effective Surgical Strategy to Treat Cancer-related LymphedemaNCT05025982
Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema
An observational study of Description of an Effective Surgical Strategy to Treat Cancer-related Lymphedema and Combination of LVA and Liposuction Guarantees Long Lasting Results, run by University of Siena at 2 sites in Italy.
Trial summary
cooperation of an International team with many years of experience in surgical management of lymphedema description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology the combination of LVA and liposuction guarantees long lasting results Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Description of an Effective Surgical Strategy to Treat Cancer-related Lymphedema, Combination of LVA and Liposuction Guarantees Long Lasting Results
- What is being tested?
- combination of lymphaticovenular anastomosis and liposuction
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Aug 2018to 1 May 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with a previous history of cancer who developed secondary lymphedema and are currently free from cancer
Who may be able to join
None listed.
Who cannot join
- persistence of the neoplastic pathology
- patients affected by primary lymphedema
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Guido Gabriele
Siena, 54100
Guido Gabriele, MD, guidogabriele1@yahoo.it
- Recruiting
Guido Gabriele
Siena, 54100
Guido Gabriele, MD
guidogabriele1@yahoo.it
About this study
Official title: Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema: Rationale for a Regional Approach
- cooperation of an International team with many years of experience in surgical management of lymphedema
- description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology
- the combination of LVA and liposuction guarantees long lasting results
Read the detailed description
Cancer-related lymphedema represents one of the major complications of cancer treatment, especially for breast and gynecologic cancers. Moreover, it has high impact on cancer survivors and healthcare systems. Lymphedema management still remains challenging. The better understanding of lymphedema physiopathology as well as the development of sophisticated surgical and diagnostic techniques have led to effective strategies to address lymphedema patients but, despite the considerable interest in international literature, no consensus exist. The combination of LVA and liposuction may represent an effective strategy in treating patients with cancer-related lymphedema, in order to reach a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it has the aim of being minimally invasive and well tolerated by patients
- Conditions
- Description of an Effective Surgical Strategy to Treat Cancer-related Lymphedema, Combination of LVA and Liposuction Guarantees Long Lasting Results
- Being tested
- combination of lymphaticovenular anastomosis and liposuction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of lymphaticovenular anastomosis and liposuctionProcedure or surgery
Surgeries were carried out under local anesthesia and light sedation.LVA was performed adopting supramicrosurgical technique.Liposuction was performed following completion of the LVA
| Study group | Role | What they receive |
|---|---|---|
| Group of partecipants | we combined two surgical techniques in the same group of patients Receives: Procedure: combination of lymphaticovenular anastomosis and liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in volume
change in volume of the limb affected by cancer-related lymphedema
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Aug 2018
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Description of an Effective Surgical Strategy to Treat Cancer-related LymphedemaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Gabriele, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025982
- Sponsor's protocol ID
- combination
- Status last verified
- Aug 2021
- First submitted
- 28 Apr 2021
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema: Rationale for a Regional Approach
- ClinicalTrials.gov ID
- NCT05025982
- Acronym / sponsor ID
- combination
- Conditions
- Description of an Effective Surgical Strategy to Treat Cancer-related Lymphedema, Combination of LVA and Liposuction Guarantees Long Lasting Results
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 30 Aug 2021 (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.
- cooperation of an International team with many years of experience in surgical management of lymphedema
- description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology
- the combination of LVA and liposuction guarantees long lasting results
Detailed description
Cancer-related lymphedema represents one of the major complications of cancer treatment, especially for breast and gynecologic cancers. Moreover, it has high impact on cancer survivors and healthcare systems. Lymphedema management still remains challenging. The better understanding of lymphedema physiopathology as well as the development of sophisticated surgical and diagnostic techniques have led to effective strategies to address lymphedema patients but, despite the considerable interest in international literature, no consensus exist. The combination of LVA and liposuction may represent an effective strategy in treating patients with cancer-related lymphedema, in order to reach a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it has the aim of being minimally invasive and well tolerated by patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of partecipants | – | Procedure: combination of lymphaticovenular anastomosis and liposuctionwe combined two surgical techniques in the same group of patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a previous history of cancer who developed secondary lymphedema and are currently free from cancer
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- persistence of the neoplastic pathology
- patients affected by primary lymphedema
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 |
|---|---|---|
| combination of lymphaticovenular anastomosis and liposuctionSurgeries were carried out under local anesthesia and light sedation.LVA was performed adopting supramicrosurgical technique.Liposuction was performed following completion of the LVA | Procedure or surgery | Group of partecipants |
Primary outcome
change in volume
Time frame: one year
change in volume of the limb affected by cancer-related lymphedema
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Description of an Effective Surgical Strategy to Treat Cancer-related Lymphedema and Combination of LVA and Liposuction Guarantees Long Lasting Results, run by University of Siena at 2 sites in Italy.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guido Gabriele, MD (3351355043, guidogabriele1@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in volume (time frame: one year). 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 30 Aug 2021.