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NCT Number: NCT03541161

Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Early Rehabilitation After Total Mastectomy and Immediate Reconstruction With Tissue Expander Insertion in Breast Cancer Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 30, 2018
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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