Photography or Video in Assessing Breast Reconstruction?
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|ClinicalTrials.gov Identifier: NCT01547338|
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : April 14, 2015
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.
|Condition or disease|
|Breast Neoplasms Breast Reconstruction|
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 Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||Comparison of Static Photography and Real Time Digital Video in the Assessment of Aesthetic Outcomes Following Breast Reconstruction|
|Study Start Date :||June 2012|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
Breast reconstruction patient
Unilateral breast reconstruction patients
- 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
- 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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547338
|Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary|
|Glasgow, United Kingdom, G4 0SF|
|Principal Investigator:||Adam Gilmour, MBChB, MRCS(Ed)||NHS Greater Glasgow & Clyde|