Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
Early Rehabilitation After Total Mastectomy and Immediate Reconstruction With Tissue Expander Insertion in Breast Cancer Patients
研究概览
地位
条件
详细说明
To prevent surgical site complications, surgeons use so-called "conventional protocol", which immobilizes shoulder and upper arm motion for a month after total mastectmoy and immediate reconstruction with tissue expander insertion. To improve shoulder mobility and QOL of patients, the investigators introduced a new and early rehabilitation protocol with short-term immobilization in Jan 2017.
The investigators retrospectively reviewed total 115 breast cancer patients who underwent reconstructive surgery from May 2016 to Aug 2017. Patients who did their reconstruction before Jan 2017 followed conventional protocol and immobilized their shoulder for more than 4 weeks. Patients who did their reconstruction after Jan 2017 were educated to undergo a self-exercise program after short-term immobilization of 2 weeks. The investigators reviewed shoulder mobility, pain, QOL and complications at postoperative 1 month and 2 month in both group of patients.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Gangnam-gu
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Seoul、Gangnam-gu、大韩民国、06351
- Samsung Medical Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Subject has breast cancer
- Subject underwent total mastectomy and immediate reconstruction with tissue expander insertion
Exclusion Criteria:
- Patients who had pre-existing conditions before breast cancer surgery that limit shoulder movement.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Early rehabilitation group
Breast cancer patients who underwent reconstructive surgery in samsung medical center from Jan 2017 to August 2017.
Following early rehabilitation protocol, patients were educated to undergo a self-exercise program after short-term immobilization of 2 weeks.
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Conventional protocol group
Breast cancer patients who underwent reconstructive surgery in samsung medical center from May 2016 to Dec 2016.
Following conventional protocol, patients were asked to immobilize their shoulder for more than 4 weeks and then undergo self-exercise program.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The shoulder range of motion (ROM)
大体时间：2 month
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Shoulder ROM was measured in flexion, abduction, external rotation and internal rotation in the affected upper limb at post-operative 1 month and 2month.
Measurements were conducted by a physiatrist using a goniometer with patients in seated position.
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2 month
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Surgical site complication
大体时间：2 month
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A plastic surgeon reviewed the surgical site for hematoma, seroma, surgical site infection, implant rupture, extrusion of the implant, asymmetry/displacement of the implant and any other complications at post-operative 1 month and 2month.
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2 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Disabilities of arm, shoulder, and hand outcome measure questionnaire
大体时间：2 month
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The DASH questionnaire was used to assess shoulder function at postoperative 1 month and 2 month.
Scores were transformed to a 0 to 100 scale.
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2 month
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Short-form 36 health survey
大体时间：2 month
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The SF36 was used to assess QOL at postoperative 1 month and 2 month.
The SF36 contains 8 sections measuring 8 domains of QOL: physical functioning (PF), role limitations because of physical health problems (RP), bodily pain (BP), general health perception (GH), vitality (VT), social functioning (SF), role limitations because of emotional problems (RE), and mental health (MH).
The 8 sections are summarized into a two-component summary: the physical component summary (PCS; PF, RP, BP, GH and VT) and mental component summary (MCS; MH, RE, SF, VT and GH).
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2 month
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Pain numeric rating scale
大体时间：2 month
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Self reported pain intensitiy at postoperative 1 month and 2 month.
It scored 0-10 (0 = no pain; 10= pain as bad as can be)
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2 month
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合作者和调查者
调查人员
- 首席研究员：Ji Hye Hwang, MD, PhD、Samsung Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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