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Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients

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Samsung Medical Center

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT03541161
SMC 2018-01-008-001

Details and patient eligibility

About

The purpose of the study is to find best post-operative rehabilitation protocol after total mastectomy and immediate reconstruction with tissue expander insertion. This study compared outcomes of two post-operative rehabilitation protocols ; "conventional protocol", which immobilized shoulder and upper arm motion for a month and "early rehabilitation protocol" with short-term immobilization period and early mobilization.

Full description

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.

Enrollment

115 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

115 participants in 2 patient groups

Early rehabilitation group
Description:
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.
Conventional protocol group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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