Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention

Study Overview
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Brief Summary
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The purpose of this comparable cohort study is to evaluate the efficacy and safety of immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema prevention in breast cancer patients who are undergoing axillary dissection.

Detailed Description
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Upper limb lymphedema is the main complication of axillary dissection. It is estimated that as many as 50% of patients undergoing lymph node dissection go on to develop lymphedema, with significantly decreased quality of life with frequent infections, decreased range of motion, and a cosmetic deformity. The treatment of lymphedema was be frustrated by technical difficulties and gave rise to a heavy budget burden. Some retrospective studies revealed that immediate and delayed breast reconstruction with lattismus dorsi flap brought unexpected relief to the upper limb lymphedema. The current study was composed to assess whether transferring a pedicled partial latissimus dorsi muscle flap to the axilla would prevent the occurrence of post-mastectomy lymphedema. This prospectively designed cohort study have two parallel arms. Patients undergoing axillary dissection would be recruited to one of the two groups, according their own preference.

Official Title
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The Efficacy and Safety of Immediate Axillary Plasty With Pedicled Partial Latissimus Dorsi Muscle Flap for Lymphedema Prevention in Breast Cancer Patients Who Undergoing Axillary Dissection: a Prospective, Corhort Study

Conditions
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Lymphedema, Breast Neoplasm

Intervention / Treatment
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* Procedure: Immediate Axillary Plasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing axillary lymph node dissection Exclusion Criteria: Prior iplateral upper limb edema Plan for breast or axillary reconstruction The thoracodorsal vessel damage Muscle flap volume too low

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Axillary Plasty<br>Immediate Axillary Plasty ：After axillary lymph node dissection, a pedicled flap named Partial Latissimus Dorsi Muscle Flap is filled in the cavity of axilla, and fixed around the axillary vessels. | Procedure: Immediate Axillary Plasty<br>* Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.<br>|
| No Intervention: Education<br>Education：After surgery, education on the prevention of lymphedema. In patients suffering with upper limb lymphedema during follow-up, any treatment except axillary or breast reconstruction can be used. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of lymphedema and/or severity of lymphedema |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Mobility | Shoulder Mobility： the difference between baseline and postoperation，including flexion extension rotation abduction and adduction. | up to 3 years | 
| Postoperation seroma | The incidence of axilla and donor site | up to one month | 
| Acute Upper limb thrombosis | The incidence of thrombosis linked to postoperation immobility | Up to one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasm, Lymphedema, Autologous flap, lattismus dorsi flap