Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema

August 26, 2021 updated by: Guido Gabriele, University of Siena

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with a previous history of cancer who developed secondary lymphedema and are currently free from cancer

Description

Inclusion Criteria: patients affected by secondary lymphedema

  • free from cancer disease

Exclusion Criteria:

- persistence of the neoplastic pathology

- patients affected by primary lymphedema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group of partecipants
we combined two surgical techniques in the same group of patients
Procedure: combination of lymphaticovenular anastomosis and liposuction
Surgeries were carried out under local anesthesia and light sedation.LVA was performed adopting supramicrosurgical technique.Liposuction was performed following completion of the LVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in volume
Time Frame: one year
change in volume of the limb affected by cancer-related lymphedema
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • combination

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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