An interventional study of Axilla dissection + Lymphovenous anastomosis in Lymphedema, Breast Cancer, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Prevention
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.
151 studies on the registry are indexed under Breast Cancer Lymphedema; 45 are open to participants now.
This study's planned enrollment of 80 is above the median of 51 across 120 interventional studies indexed under Breast Cancer Lymphedema.
Browse Breast Cancer Lymphedema studies →University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Surgical bypass between lymphatic vessel and vein
Procedure: Axilla dissection + Lymphovenous anastomosis
Standard surgery
surgical bypass between lymphatic vessel and vein
The volume via circumferential measurements: swelling < 5%
Comparing the volume of the arm at each study visit via circumferential measurements: swelling \< 5%
Time frame: 2 years
Plan to share: No
Started Jun 2021 (actual). Primary completion is estimated for Dec 2025, 53 months after the start.
Of 78 non-industry interventional studies with no phase under Breast Cancer Lymphedema, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 71. This study's planned 53 months is above that.
Counting every sponsor, half of 81 studies reached it within 18 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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