Breast Augmentation Rehabilitation Program | NCT01857765

Studies
Breast Augmentation Rehabilitation Program

NCT01857765

Sponsor

University of British Columbia

Status

Withdrawn

Last Update Posted

Oct 13, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Implants
Surgery, Plastic

Interventions

Rehabilitation
Follow-up

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The resident in charge of the project has graduated so we decided to close this study

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Sep 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

May 9, 2013

First Submission Date that Met QC Criteria

May 15, 2013

First Posted Date

May 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2014

Last Update Posted Date

Oct 13, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care	Active Comparator		Behavioral: Follow-up
Rehabilitation	Experimental		Behavioral: Rehabilitation Behavioral: Follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rehabilitation	Behavioral	Range of motion stretching exercises	Rehabilitation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erin Brown, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of British Columbia		Vancouver	British Columbia		Canada

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided