Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03541161|
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||115 participants|
|Official Title:||Early Rehabilitation After Total Mastectomy and Immediate Reconstruction With Tissue Expander Insertion in Breast Cancer Patients|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||October 2017|
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.
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.
- The shoulder range of motion (ROM) [ Time Frame: 2 month ]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.
- Surgical site complication [ Time Frame: 2 month ]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.
- Disabilities of arm, shoulder, and hand outcome measure questionnaire [ Time Frame: 2 month ]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.
- Short-form 36 health survey [ Time Frame: 2 month ]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).
- Pain numeric rating scale [ Time Frame: 2 month ]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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541161
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Gangnam-gu, Korea, Republic of, 06351|
|Principal Investigator:||Ji Hye Hwang, MD, PhD||Samsung Medical Center|