Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Secondary Lymphedema, Breast Cancer

Intervention / Treatment
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* Procedure: Surgery
* Other: Compression and drainage therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema. Exclusion Criteria: Frequent or severe cellulitis. All other lymphedema.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Lymphovenous anastomosis | Procedure: Surgery<br>* Lymphovenous anastomosis<br>|
| Active Comparator: Compression<br>Conservative treatment with physiotherapy and compression | Other: Compression and drainage therapy<br>* Treatment with compression stockings and manual drainage (massage therapy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume | Volume of arm as described by submersion and circumference measures | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life ULL27 | To be measured by questionnaire Upper Limb Lymphedema score 27 (ULL27) by Professor Robert Launois at REES France. The scale measures health related quality of life in patients with upper limb lymphedema. Construction: 27 questions rated from 1 (lowest quality of life) to 5 highest quality of life. Dimensions: There are 3 dimensions assessing symptoms, self value, everyday social life. Total score 27-135 Symptom score: 18-90 Self value: 5-25 Social life: 4-20 Question 20 and 22 are part of the self value dimension and are control questions with reverse scores, i.e 1 represents highest quality of life and 5 represents lowest quality of life. The scores for question 20 and 22 are later reversed when adding the total score. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphovenous bypass, Lymphovenous anastomosis, Lymphangiography, Supermicrosurgery, MD Anderson Lymphedema Stage