Spots Global Cancer Trial Database for Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

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Trial Identification

Brief Title: Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Official Title: Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.

Study ID: NCT03578380

Conditions

Secondary Lymphedema

Breast Cancer

Interventions

Surgery

Compression and drainage therapy

Study Description

Brief Summary: A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.

Detailed Description: This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).