Breast Neoplasm, Lymphedema
Conditions
Keywords
Breast Neoplasm, Lymphedema, Autologous flap, lattismus dorsi flap
Brief summary
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
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.
Interventions
PROCEDUREImmediate Axillary Plasty
Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.
Sponsors
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of lymphedema and/or severity of lymphedema | Up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Mobility | up to 3 years | Shoulder Mobility： the difference between baseline and postoperation，including flexion extension rotation abduction and adduction. |
| Postoperation seroma | up to one month | The incidence of axilla and donor site |
| Acute Upper limb thrombosis | Up to one month | The incidence of thrombosis linked to postoperation immobility |
Contacts
Primary ContactHoupu Yang, MD
Outcome results
None listed