COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA

Sponsor

University of Siena (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04536064

Collaborator

(none)

Enrollment

Location

50.2

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology	Procedure: LVA and liposuction

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 authors present a retrospective analysis of 24 consecutive patients affected by cancer-related lymphedema treated by the combination of LVA and liposuction in the same surgical session. Patients data regarding limb volume, lymphangitis rate and quality of life index were assessed before surgery and 1 year after surgery.

One year after surgery an average volume reduction of 37,9% was registered. Lymphangitis rate significantly decreased after surgery to 0.95 per year. Quality of life score improved.

CONCLUSIONS The combination of LVA and liposuction represents an effective strategy in treating patients with cancer-related lymphedema, ensuring a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it appears to be minimally invasive and well tolerated by patients, since it can be performed under local anesthesia with low risk of complications.

Study Design

Study Type:

Observational

Actual Enrollment :

24 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION TO TREAT CANCER-RELATED LYMPHEDEMA: RATIONALE FOR A REGIONAL APPROACH

Actual Study Start Date :

Feb 22, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

May 1, 2025

Outcome Measures

Primary Outcome Measures

Volume reduction of the limb [one year after surgery]
mesurement of volume reduction

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

previous lymphadenectomy

Exclusion Criteria:

free from cancer related pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guido Gabriele	Siena	SI	Italy	54100

Sponsors and Collaborators

University of Siena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guido Gabriele, MD, University of Siena

ClinicalTrials.gov Identifier:

NCT04536064

Other Study ID Numbers:

LVA+LIPOSUCTION IN LYMPHEDEMA

First Posted:

Sep 2, 2020

Last Update Posted:

Feb 24, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Guido Gabriele, MD, University of Siena

Additional relevant MeSH terms:

Lymphedema

Study Results

No Results Posted as of Feb 24, 2021