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RecruitingNot ApplicableNCT04687956

Primary Surgical Prevention of Breast Cancer-related Lymphedema

Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema

Sponsor

Gangnam Severance Hospital

Enrollment

72 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

Breast CancerMastectomyLymphedema

Summary

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests a surgical technique during breast cancer surgery to prevent lymphedema — a painful, long-term arm swelling that can occur after lymph nodes are removed from the armpit. The technique involves reconnecting small lymphatic vessels at the time of the original surgery, before swelling ever develops. **You may be eligible if...** - You are over 19 years old - You have breast cancer and are scheduled for surgery that includes removal of axillary (armpit) lymph nodes **You may NOT be eligible if...** - You have vascular or lymphatic disease in either arm - You have had prior surgery or trauma to both arms or armpits - You have had prior radiation to the arms, chest, or armpits - Your cancer has spread throughout the body (stage 4) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELYMPHA

Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.

PROCEDUREcontrol

In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.

Locations(1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

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NCT04687956

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