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
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 主要终点
- Incidence of lymphedema and/or severity of lymphedema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing axillary lymph node dissection
排除标准
- •Prior iplateral upper limb edema
- •Plan for breast or axillary reconstruction
- •The thoracodorsal vessel damage
- •Muscle flap volume too low
研究组 & 干预措施
Immediate Axillary Plasty
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.
干预措施: Immediate Axillary Plasty (Procedure)
Education
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.
结局指标
主要结局
Incidence of lymphedema and/or severity of lymphedema
时间窗: Up to 3 years
次要结局
- Acute Upper limb thrombosis(Up to one month)
- Shoulder Mobility(up to 3 years)
- Postoperation seroma(up to one month)
