Breast NeoplasmsNCT01547338
Photography or Video in Assessing Breast Reconstruction?
An observational study of Breast Neoplasms and Breast Reconstruction, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Current qualitative methods of assessing the aesthetic result following breast reconstruction are known to be poor. The investigators believe that real time digital video footage followed by expert panel review would be a superior method of qualitative assessment of breast cancer reconstruction aesthetics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Reconstruction
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Jan 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Breast reconstruction patients attending for Nipple Areola Complex Tattoing
Who may be able to join
- Female patient
- Minimum 18 years of age
- Due to attend for Nipple areola complex tattooing
- Previous unilateral breast reconstruction following mastectomy
Who cannot join
- Male patient
- Bilateral Breast Reconstruction
- Reconstruction less than 1year ago
- Breast reconstruction not following breast cancer excision
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, G4 0SF
About this study
Official title: Comparison of Static Photography and Real Time Digital Video in the Assessment of Aesthetic Outcomes Following Breast Reconstruction
Current qualitative methods of assessing the aesthetic result following breast reconstruction are known to be poor.
The investigators believe that real time digital video footage followed by expert panel review would be a superior method of qualitative assessment of breast cancer reconstruction aesthetics. This has never been studied before.
Read the detailed description
Breast cancer is the commonest cancer to affect women in the UK. Current guidelines state that; disease permitting, all females due to undergo mastectomy for breast cancer should be offered reconstruction. This usually takes place in the form of implant based reconstruction, regional flap based reconstruction +/- implant or free autologous tissue based reconstruction.
Traditional methods of subjectively assessing the aesthetic outcome of any of the forms of breast surgery have been shown to be poor and the assessment of immediate reconstructions a cumbersome task. The qualitative part of the assessment usually relies on standardised clinical photographs and panel ratings. Four to six photographs are usually taken of the patient and their reconstruction from different angles. These photographs are then shown to an expert panel (usually consisting of healthcare professionals familiar with breast reconstruction).
A large degree of both inter and intra-observer bias exists when comparing standardized photographs. The results from expert assessment of cosmesis often do not correlate to the patients opinion with regards to the cosmetic outcome of their reconstruction
Due to the static nature of clinical photography it does not capture the effect which movement and gravity play on a reconstructed breast in comparison to a normal breast.
A large volume of information can be captured from a short digital video clip in comparison to a single photograph. The potential advantages of digital video assessment over photography are only beginning to be explored with regards to aesthetics in other fields associated to medicine.9 However this has never been trialed with regards to breast cancer reconstruction.
We believe that real time digital video footage would be a more valuable tool in the assessment of breast reconstruction. We believe that there may be more accurate correlations between patient's satisfaction and panel opinion and that there will be less inter and intra-observer discordance
- Conditions
- Breast Neoplasms, Breast Reconstruction
- Keywords
- Breast, Reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast reconstruction patient | Unilateral breast reconstruction patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter/Intra observer correlation on cosmetic scale using digital video footage
The primary aim of this study is to assess the level of inter and intra rater agreement for the expert panel on each of the 6 questions on the cosmetic outcome of breast reconstruction patients using digital video footage
Measured: Outcome measure will be assessed approximately 1 year post breast reconstruction
Secondary outcomes (1)
Comparison of digital video footage panel scores against patient self-assessment scores
If the above primary and secondary objectives show that the intra-observer agreement is good, to compare the agreement between patients' self-assessment and expert panel assessment
Measured: Outcome measure will be assessed approximately 1 year post breast reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Gilmour, NHS Greater Glasgow and Clyde
- Investigators
- Adam Gilmour, MBChB, MRCS(Ed), Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547338
- Sponsor's protocol ID
- GN12SU052
- Status last verified
- Apr 2015
- First submitted
- 27 Feb 2012
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gilmour A, Mackay IR, Young D, Hill ME, Brown L, Malyon AD. The use of real-time digital video in the assessment of post-operative outcomes of breast reconstruction. J Plast Reconstr Aesthet Surg. 2014 Oct;67(10):1357-63. doi: 10.1016/j.bjps.2014.05.036. Epub 2014 Jun 2.
PubMed 24923524
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Static Photography and Real Time Digital Video in the Assessment of Aesthetic Outcomes Following Breast Reconstruction
- ClinicalTrials.gov ID
- NCT01547338
- Acronym / sponsor ID
- GN12SU052
- Conditions
- Breast Neoplasms, Breast Reconstruction
- Keywords
- Breast, Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Mar 2012 (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.
Current qualitative methods of assessing the aesthetic result following breast reconstruction are known to be poor.
The investigators believe that real time digital video footage followed by expert panel review would be a superior method of qualitative assessment of breast cancer reconstruction aesthetics. This has never been studied before.
Detailed description
Breast cancer is the commonest cancer to affect women in the UK. Current guidelines state that; disease permitting, all females due to undergo mastectomy for breast cancer should be offered reconstruction. This usually takes place in the form of implant based reconstruction, regional flap based reconstruction +/- implant or free autologous tissue based reconstruction.
Traditional methods of subjectively assessing the aesthetic outcome of any of the forms of breast surgery have been shown to be poor and the assessment of immediate reconstructions a cumbersome task. The qualitative part of the assessment usually relies on standardised clinical photographs and panel ratings. Four to six photographs are usually taken of the patient and their reconstruction from different angles. These photographs are then shown to an expert panel (usually consisting of healthcare professionals familiar with breast reconstruction).
A large degree of both inter and intra-observer bias exists when comparing standardized photographs. The results from expert assessment of cosmesis often do not correlate to the patients opinion with regards to the cosmetic outcome of their reconstruction
Due to the static nature of clinical photography it does not capture the effect which movement and gravity play on a reconstructed breast in comparison to a normal breast.
A large volume of information can be captured from a short digital video clip in comparison to a single photograph. The potential advantages of digital video assessment over photography are only beginning to be explored with regards to aesthetics in other fields associated to medicine.9 However this has never been trialed with regards to breast cancer reconstruction.
We believe that real time digital video footage would be a more valuable tool in the assessment of breast reconstruction. We believe that there may be more accurate correlations between patient's satisfaction and panel opinion and that there will be less inter and intra-observer discordance
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast reconstruction patient | – | –Unilateral breast reconstruction patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast reconstruction patients attending for Nipple Areola Complex Tattoing
Key inclusion criteria (4 listed)
- Female patient
- Minimum 18 years of age
- Due to attend for Nipple areola complex tattooing
- Previous unilateral breast reconstruction following mastectomy
Key exclusion criteria (4 listed)
- Male patient
- Bilateral Breast Reconstruction
- Reconstruction less than 1year ago
- Breast reconstruction not following breast cancer excision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter/Intra observer correlation on cosmetic scale using digital video footage
Time frame: Outcome measure will be assessed approximately 1 year post breast reconstruction
The primary aim of this study is to assess the level of inter and intra rater agreement for the expert panel on each of the 6 questions on the cosmetic outcome of breast reconstruction patients using digital video footage
1 secondary outcome
Comparison of digital video footage panel scores against patient self-assessment scores
Time frame: Outcome measure will be assessed approximately 1 year post breast reconstruction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Results publication: PubMed 24923524Gilmour A, Mackay IR, Young D, Hill ME, Brown L, Malyon AD. The use of real-time digital video in the assessment of post-operative outcomes of breast reconstruction. J Plast Reconstr Aesthet Surg. 2014 Oct;67(10):1357-63. doi: 10.1016/j.bjps.2014.05.036. Epub 2014 Jun 2.
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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.
Adam Gilmour, MBChB, MRCS(Ed) principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Reconstruction, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 14 Apr 2015. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inter/Intra observer correlation on cosmetic scale using digital video footage (time frame: Outcome measure will be assessed approximately 1 year post breast reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547338, which also lists 1 linked publication.
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 14 Apr 2015.