NCT03541161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

May 7, 2018

Last Update Submit

May 29, 2018

Conditions

Breast Cancer

Keywords

Early rehabilitationConventional protocolTissue expander insertion

Outcome Measures

Primary Outcomes (2)

  • The shoulder range of motion (ROM)

    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 month

  • Surgical site complication

    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.

    2 month

Secondary Outcomes (3)

  • Disabilities of arm, shoulder, and hand outcome measure questionnaire

    2 month

  • Short-form 36 health survey

    2 month

  • Pain numeric rating scale

    2 month

Study Arms (2)

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Subject has breast cancer
  • Subject underwent total mastectomy and immediate reconstruction with tissue expander insertion

You may not qualify if:

  • Patients who had pre-existing conditions before breast cancer surgery that limit shoulder movement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31598346DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ji Hye Hwang, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Physical & Rehabilitation Medicine Samsung Medical Center

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 30, 2018

Study Start

May 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)