Breast Augmentation Rehabilitation Program

Breast Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01857765
• Other study ID #: H11-02077
• Status: Withdrawn
• Phase: N/A
• First received: May 9, 2013
• Last updated: October 10, 2014
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Implants
• Surgery, Plastic

Intervention

Behavioral:
• Rehabilitation
Range of motion stretching exercises
• Follow-up
Follow-up with surgeon's clinic

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to return to baseline as measured on Visual Analogue Scale for pain		Baseline, six months, and one year after surgery	No
Secondary	Time to return to bilateral shoulder baseline range of motion		Baseline, six months, and one year after surgery	No
Secondary	Change in psychosocial outcomes as measured by the BREAST-Q questionnaire		Baseline, six months, and one year after surgery	No