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OpenTrials
Completed

NCT Number: NCT01547338

Photography or Video in Assessing 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2012
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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