Breast Augmentation Rehabilitation Program

• Sponsor: University of British Columbia (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01857765
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2013
• Anticipated Primary Completion Date: Sep 1, 2014
• Anticipated Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

1. Time to return to bilateral shoulder baseline range of motion [Baseline, six months, and one year after surgery]

2. Change in psychosocial outcomes as measured by the BREAST-Q questionnaire [Baseline, six months, and one year after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of British Columbia
• ClinicalTrials.gov Identifier: NCT01857765
• Other Study ID Numbers: H11-02077
• First Posted: May 20, 2013
• Last Update Posted: Oct 13, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by University of British Columbia: rehabilitation; reconstructive surgery

Study Results

No Results Posted as of Oct 13, 2014