Breast Augmentation Rehabilitation Program

October 10, 2014 updated by: University of British Columbia

How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Behavioral: Follow-up
Follow-up with surgeon's clinic
Experimental: Rehabilitation
Behavioral: Follow-up
Follow-up with surgeon's clinic
Behavioral: Rehabilitation
Range of motion stretching exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to return to baseline as measured on Visual Analogue Scale for pain
Time Frame: Baseline, six months, and one year after surgery
Baseline, six months, and one year after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 10, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H11-02077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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