NCT01857765

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

May 9, 2013

Last Update Submit

October 10, 2014

Conditions

Breast ImplantsSurgery, Plastic

Keywords

rehabilitationreconstructive surgery

Outcome Measures

Primary Outcomes (1)

  • Time to return to baseline as measured on Visual Analogue Scale for pain

    Baseline, six months, and one year after surgery

Secondary Outcomes (2)

  • 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR
Behavioral: Follow-up

Rehabilitation

EXPERIMENTAL
Behavioral: RehabilitationBehavioral: Follow-up

Interventions

RehabilitationBEHAVIORAL

Range of motion stretching exercises

Rehabilitation
Follow-upBEHAVIORAL

Follow-up with surgeon's clinic

RehabilitationStandard of Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women who undergo endoscopic transaxillary subpectoral breast augmentation
  • women above the age of 18 years
  • women with a BMI 18-27

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Erin Brown, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 20, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

CA(1)