Clinical Trials Directory

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UnknownNCT04536064

COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA

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

Status
Unknown
Phase
Study type
Observational
Enrollment
24 (actual)
Sponsor
University of Siena · Academic / Other
Sex
All
Age
Healthy volunteers

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELVA and liposuctionTumescent technique in lymph-sparing fashion was adopted. Areas were infiltrated with a mix of a standard tumescent solution consisting for each liter of in 1000 ml of saline solution, 50 ml lidocaine 1%, 1 ml epinephrine 1:1000, 10 ml bicarbonate 8,4%. Infiltration volume was approximately from 0,5 to 1 liter for the upper extremities and 1-2 liters for lowers. Three to 4 mm 3 holes blunt cannulas were employed. Aspiration technique was as parallel as possible along the lymphatic network pattern and from superficial to deep layers. Lymphatic vessels identified at ICG lymphography were spared. Volume of the aspirate was aimed to approximate 80 percent of the volume difference between the affected and non affected side. The number and type of anastomosis were recorded as well as amount of removed lipoaspirate versus the excess limb volume.

Timeline

Start date
2021-02-22
Primary completion
2022-09-01
Completion
2025-05-01
First posted
2020-09-02
Last updated
2021-02-24

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04536064. Inclusion in this directory is not an endorsement.