Breast Augmentation Rehabilitation Program

This study has been withdrawn prior to enrollment.
(The resident in charge of the project has graduated so we decided to close this study)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01857765
First received: May 9, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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 Intervention
Breast Implants
Surgery, Plastic
Behavioral: Rehabilitation
Behavioral: Follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Time to return to baseline as measured on Visual Analogue Scale for pain [ Time Frame: Baseline, six months, and one year after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to return to bilateral shoulder baseline range of motion [ Time Frame: Baseline, six months, and one year after surgery ] [ Designated as safety issue: No ]
  • Change in psychosocial outcomes as measured by the BREAST-Q questionnaire [ Time Frame: Baseline, six months, and one year after surgery ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01857765     History of Changes
Other Study ID Numbers: H11-02077
Study First Received: May 9, 2013
Last Updated: October 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
rehabilitation
reconstructive surgery

ClinicalTrials.gov processed this record on October 19, 2014