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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
Sponsor:
Information provided by (Responsible Party):
JiHye Hwang, Samsung Medical Center

Study Description
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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.

Condition or disease
Breast Cancer

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.

Study Design
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Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541161


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Gangnam-gu, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Ji Hye Hwang, MD, PhD Samsung Medical Center
  Study Documents (Full-Text)

Documents provided by JiHye Hwang, Samsung Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] May 6, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: JiHye Hwang, Chairman, Physical & Rehabilitation Medicine Samsung Medical Center, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03541161    
Other Study ID Numbers: SMC 2018-01-008-001
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JiHye Hwang, Samsung Medical Center:
Early rehabilitation
Conventional protocol
Tissue expander insertion
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases