Lymphedema, Breast Cancer Clinical Trial
— LYMPHAOfficial title:
A Randomized Controlled Trial to Assess the Efficacy of the Lymphatic Microsurgical Preventive Healing Approach (LYMPHA) to Prevent Lymphedema After Axillary Dissection for Breast Cancer
Lymphedema is the Build-up of Lymph Fluid in the Body's Tissue Causing Chronic, Debilitating Swelling. This Commonly Occurs as a Result of a Disruption of the Lymphatic System During Lymph Node Dissection Surgeries. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an Innovative Microsurgical Technique Where Blocked Lymphatic Vessels Are Drained Into the Blood Circulation by Surgically Creating a Shunt Between a Lymphatic Channel and a Blood Vessel Called a Lymphatic-venous Bypass. Recently, LYMPHA Technique Has Been Shown to Prevent Lymphedema When Performed at the Time of Nodal Dissection. We Propose a Prospective Study Evaluating the Effectiveness of LYMPHA Technique Using Objective Clinical Protocol.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - Node-positive cancer requiring an axillary or lymphadenectomy - Below 30 Body Mass Index Exclusion Criteria: - Patients receiving a sentinel lymph node biopsy - Patients with established preoperative lymphedema - Patients with post-thrombotic syndrome, peripheral vascular disease - Pregnant patients |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pusan National University Hospital | Busan | Seo-Gu |
Lead Sponsor | Collaborator |
---|---|
Pusan National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lymphatic flow | Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group | 6 months | |
Primary | limb volume | Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group | 6 months | |
Primary | lymphatic flow | Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group | 1 year | |
Primary | limb volume | Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group | 1 year |
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