Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
NCT ID: NCT03541161
Last Updated: 2018-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
115 participants
OBSERVATIONAL
2016-05-31
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject underwent total mastectomy and immediate reconstruction with tissue expander insertion
Exclusion Criteria
FEMALE
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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JiHye Hwang
Chairman, Physical & Rehabilitation Medicine Samsung Medical Center
Principal Investigators
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Ji Hye Hwang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Countries
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References
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Kim KH, Yeo SM, Cheong IY, Kim Y, Jeon BJ, Hwang JH. Early Rehabilitation after Total Mastectomy and Immediate Reconstruction with Tissue Expander Insertion in Breast Cancer Patients: A Retrospective Case-control Study. J Breast Cancer. 2019 Sep;22(3):472-483. doi: 10.4048/jbc.2019.22.e40.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SMC 2018-01-008-001
Identifier Type: -
Identifier Source: org_study_id
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