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Clinical Trials/NCT01547338
NCT01547338CompletedNot Applicable

Comparison of Static Photography and Real Time Digital Video in the Assessment of Aesthetic Outcomes Following Breast Reconstruction

NHS Greater Glasgow and Clyde1 site in 1 country35 target enrollmentStarted: June 2012Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adam Gilmour

Clinical Laser Research Fellow

NHS Greater Glasgow and Clyde

Study Sites (1)

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