跳至主要内容
临床试验/NCT02318615
NCT02318615Unknown不适用

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

Peking University People's Hospital0 个研究点目标入组 450 人开始时间: 2015年12月最近更新:
适应症

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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

相似试验