Comparison of Static Photography and Real Time Digital Video in the Assessment of Aesthetic Outcomes Following Breast Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Inter/Intra observer correlation on cosmetic scale using digital video footage
Study Overview
Brief 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. 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patient
- •Minimum 18 years of age
- •Due to attend for Nipple areola complex tattooing
- •Previous unilateral breast reconstruction following mastectomy
Exclusion Criteria
- •Male patient
- •Bilateral Breast Reconstruction
- •Reconstruction less than 1year ago
- •Breast reconstruction not following breast cancer excision
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Comparison of digital video footage panel scores against patient self-assessment scores(Outcome measure will be assessed approximately 1 year post breast reconstruction)
Investigators
Adam Gilmour
Clinical Laser Research Fellow
NHS Greater Glasgow and Clyde
