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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004751-16 | EudraCT Number |
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Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.
The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axilla dissection + Lymphevenous Anastomosis | Experimental | Surgical bypass between lymphatic vessel and vein |
|
| Standard surgery | No Intervention | Standard surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axilla dissection + Lymphovenous anastomosis | Procedure | surgical bypass between lymphatic vessel and vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| The volume via circumferential measurements: swelling < 5% | Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5% | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernard Depypere, MD | Contact | 093325730 | bernard.depypere@ugent.be | |
| Jessie De Kinder | Contact | 093321373 | jessie.dekinder@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Bernard Depypere, MD | UZ GENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ GENT | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33968557 | Background | Depypere B, Vyncke T, Dhooghe N, Claes K, Blondeel P, Van Landuyt K. A Novel Technique for Preventive Lymphovenous Anastomosis: Anastomosing a Ligated Lymphatic Vessel. Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3509. doi: 10.1097/GOX.0000000000003509. eCollection 2021 Mar. |
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
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blinded randomized prospective
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |