Photography or Video in Assessing Breast Reconstruction?
Comparison of Static Photography and Real Time Digital Video in the Assessment of Aesthetic Outcomes Following Breast Reconstruction
1 other identifier
observational
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
February 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 14, 2015
April 1, 2015
7 months
February 27, 2012
April 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
Outcome measure will be assessed approximately 1 year post breast reconstruction
Study Arms (1)
Breast reconstruction patient
Unilateral breast reconstruction patients
Eligibility Criteria
Breast reconstruction patients attending for Nipple Areola Complex Tattoing
You may qualify if:
- Female patient
- Minimum 18 years of age
- Due to attend for Nipple areola complex tattooing
- Previous unilateral breast reconstruction following mastectomy
You may not qualify if:
- Male patient
- Bilateral Breast Reconstruction
- Reconstruction less than 1year ago
- Breast reconstruction not following breast cancer excision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Related Publications (1)
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.
PMID: 24923524RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Gilmour, MBChB, MRCS(Ed)
NHS Greater Glasgow & Clyde
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Laser Research Fellow
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 7, 2012
Study Start
June 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
April 14, 2015
Record last verified: 2015-04