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Breast Augmentation Rehabilitation Program

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ClinicalTrials.gov Identifier: NCT01857765
Recruitment Status : Withdrawn (The resident in charge of the project has graduated so we decided to close this study)
First Posted : May 20, 2013
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Study Description
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Brief Summary:
The purpose of this study is to determine whether implementing a rehabilitation program can improve the post-operative time to pain free living after breast augmentation.

Condition or disease Intervention/treatment Phase
Breast Implants Surgery, Plastic Behavioral: Rehabilitation Behavioral: Follow-up Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation
Study Start Date : May 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard of Care Behavioral: Follow-up
Follow-up with surgeon's clinic
Experimental: Rehabilitation Behavioral: Rehabilitation
Range of motion stretching exercises
Behavioral: Follow-up
Follow-up with surgeon's clinic


Outcome Measures
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Primary Outcome Measures :
  1. Time to return to baseline as measured on Visual Analogue Scale for pain [ Time Frame: Baseline, six months, and one year after surgery ]

Secondary Outcome Measures :
  1. Time to return to bilateral shoulder baseline range of motion [ Time Frame: Baseline, six months, and one year after surgery ]
  2. Change in psychosocial outcomes as measured by the BREAST-Q questionnaire [ Time Frame: Baseline, six months, and one year after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women who undergo endoscopic transaxillary subpectoral breast augmentation
  • women above the age of 18 years
  • women with a BMI 18-27

Exclusion Criteria:

  • women who underwent previous breast reconstruction (cosmetic or therapeutic)
  • women who underwent previous chest surgery
  • women with previous chest trauma
  • women who underwent previous shoulder/arm surgery
  • women with previous shoulder/arm injury
  • women who smoke
  • women who are Immunocompromised
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01857765


Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Erin Brown, MD University of British Columbia
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01857765     History of Changes
Other Study ID Numbers: H11-02077
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by University of British Columbia:
rehabilitation
reconstructive surgery