Photography or Video in Assessing Breast Reconstruction?

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Adam Gilmour, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01547338
First received: February 27, 2012
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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
Breast Neoplasms
Breast Reconstruction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparison of Static Photography and Real Time Digital Video in the Assessment of Aesthetic Outcomes Following Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Inter/Intra observer correlation on cosmetic scale using digital video footage [ Time Frame: Outcome measure will be assessed approximately 1 year post breast reconstruction ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 35
Study Start Date: June 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast reconstruction patient
Unilateral breast reconstruction patients

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast reconstruction patients attending for Nipple Areola Complex Tattoing

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547338

Locations
United Kingdom
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Adam Gilmour, MBChB, MRCS(Ed) NHS Greater Glasgow & Clyde
  More Information

No publications provided

Responsible Party: Adam Gilmour, Clinical Laser Research Fellow, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01547338     History of Changes
Other Study ID Numbers: GN12SU052
Study First Received: February 27, 2012
Last Updated: May 11, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
Breast
Reconstruction

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014