Breast ImplantsNCT01857765
Breast Augmentation Rehabilitation Program
A study testing Rehabilitation and Follow-up in people with Breast Implants and Surgery, Plastic, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implants, Surgery, Plastic
- What is being tested?
- Rehabilitation and Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women who undergo endoscopic transaxillary subpectoral breast augmentation
- women above the age of 18 years
- women with a BMI 18-27
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Implants, Surgery, Plastic
- Being tested
- Rehabilitation, Follow-up
- Keywords
- rehabilitation, reconstructive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
Range of motion stretching exercises
Follow-upBehavioural
Follow-up with surgeon's clinic
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Behavioral: Follow-up |
| Rehabilitation | Experimental | Not described Receives: Behavioral: Rehabilitation; Behavioral: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to baseline as measured on Visual Analogue Scale for pain
Measured: Baseline, six months, and one year after surgery
Secondary outcomes (2)
Time to return to bilateral shoulder baseline range of motion
Measured: Baseline, six months, and one year after surgery
Change in psychosocial outcomes as measured by the BREAST-Q questionnaire
Measured: Baseline, six months, and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Why it stopped: The resident in charge of the project has graduated so we decided to close this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ImplantsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Brown, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857765
- Sponsor's protocol ID
- H11-02077
- Status last verified
- Oct 2014
- First submitted
- 9 May 2013
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation
- ClinicalTrials.gov ID
- NCT01857765
- Acronym / sponsor ID
- H11-02077
- Conditions
- Breast Implants, Surgery, Plastic
- Keywords
- rehabilitation, reconstructive surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The resident in charge of the project has graduated so we decided to close this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Follow-up |
| Rehabilitation | Experimental | Behavioral: Rehabilitation, Behavioral: Follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women who undergo endoscopic transaxillary subpectoral breast augmentation
- women above the age of 18 years
- women with a BMI 18-27
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationRange of motion stretching exercises | Behavioural | Rehabilitation |
| Follow-upFollow-up with surgeon's clinic | Behavioural | Rehabilitation, Standard of Care |
Primary outcome
Time to return to baseline as measured on Visual Analogue Scale for pain
Time frame: Baseline, six months, and one year after surgery
2 secondary outcomes
Time to return to bilateral shoulder baseline range of motion
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Brown, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation and Follow-up in people with Breast Implants and Surgery, Plastic, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to return to baseline as measured on Visual Analogue Scale for pain (time frame: Baseline, six months, and one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.