Clinical trial NCT03541161: Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
Official title: Early Rehabilitation After Total Mastectomy and Immediate Reconstruction With Tissue Expander Insertion in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Early rehabilitation
Conventional protocol
Tissue expander insertion
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 115
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients who underwent total mastectomy and immediate reconstruction with tissue expander insertion in samsung medical center by a plastic surgeon between May 2016 and August 2017

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The shoulder range of motion (ROM)
timeFrame: 2 month
measure: Surgical site complication
timeFrame: 2 month
Secondary outcomes:
measure: Disabilities of arm, shoulder, and hand outcome measure questionnaire
timeFrame: 2 month
measure: Short-form 36 health survey
timeFrame: 2 month
measure: Pain numeric rating scale
timeFrame: 2 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
affiliation: Samsung Medical Center
name: Ji Hye Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.