Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Measurement of the muscular moment
研究概览
简要总结
This study will quantify the muscle function after breast reconstruction using a minimally invasive latissimus dorsi flap.
The proposed measures (clinical, isokinetic, electrophysiology, function and quality of life questionnaires) allow a precise, multidisciplinary, objective evaluation of the capacity of the latissimus dorsi muscle before surgery, 3 months, 6 months and 12 months after surgery. A function deficit is expected (decreased moment of adduction and internal rotation) 3 months after surgery and a return to the preoperative state 6 months and 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.
- •Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months
- •Age between 18 and 80 years old
- •Signature of free and informed consent
排除标准
- •Patient with metastasis or disease progression
- •Patient whose general condition does not allow her to answer a questionnaire or perform physical and functional measurements (neurocognitive disorders and/or neuro-orthopedic disorders)
- •Patient with a poor understanding of the French language
- •Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
- •Patient not eligible for MR secondary to cancer (prophylactic mastectomy) or for which the flap was intended to cover loss of substance and not reconstruction
- •Patient with a history of contralateral MR (all techniques combined)
- •Patient with a history of contralateral breast cancer
- •Patient does not have internet access to be able to connect to the "Exolis" software
研究组 & 干预措施
Surgery for unilateral breast reconstruction
Patients treated in oncological surgery at the Center Georges-François Leclerc (CGFL) in Dijon for unilateral breast reconstruction after therapeutic total mastectomy.
Before the surgery, 2 questionnaires will be completed by patients : BREAST-Q and DASH. Also, the isokinetic test and EMG will be performed.
After the surgery, 2 questionnaires will be completed at one month, 3 months, 6 months and 12 months. The Two tests will be performed at 3 months, 6 months and 12 months after the surgery.
干预措施: Surgery for unilateral breast reconstruction (Procedure)
结局指标
主要结局
Measurement of the muscular moment
时间窗: During the 12 months post operation
Measurement of the muscular moment of shoulder adduction preoperatively and at 3 months on an isokinetic dynamometer (Biodex®, New York, USA) at an adduction speed of 60 degrees per second during a maximal voluntary contraction
次要结局
- Functional clinical impact and quality of life(During the 12 months post operation)
- Evaluation of muscle moments(During the 12 months post operation)
- Comparison of muscular moments(During the 12 months post operation)
- Calculation of adduction deficit(During the 12 months post operation)
- Measurement of surface electromyographic activity(During the 12 months post operation)