COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA
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| ClinicalTrials.gov Identifier: NCT04536064 |
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Recruitment Status :
Enrolling by invitation
First Posted : September 2, 2020
Last Update Posted : February 24, 2021
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- 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 |
|---|---|
| Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology | Procedure: LVA and liposuction |
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 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 : | February 22, 2021 |
| Estimated Primary Completion Date : | September 1, 2022 |
| Estimated Study Completion Date : | May 1, 2025 |
- Procedure: LVA and liposuction
Tumescent 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.
- Volume reduction of the limb [ Time Frame: one year after surgery ]mesurement of volume reduction
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
previous lymphadenectomy
Exclusion Criteria:
free from cancer related pathology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536064
| Italy | |
| Guido Gabriele | |
| Siena, SI, Italy, 54100 | |
| Responsible Party: | Guido Gabriele, MD, University of Siena |
| ClinicalTrials.gov Identifier: | NCT04536064 |
| Other Study ID Numbers: |
LVA+LIPOSUCTION IN LYMPHEDEMA |
| First Posted: | September 2, 2020 Key Record Dates |
| Last Update Posted: | February 24, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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lymphedema lva liposuction treatment |
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Lymphedema Lymphatic Diseases |