Clinical trial · Observational
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
NCT01547338CI-TRIAL-00017504completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Breast reconstruction patient
- description
- Unilateral breast reconstruction patients
Primary outcomes (1)
- measure
- Inter/Intra observer correlation on cosmetic scale using digital video footage
- timeFrame
- Outcome measure will be assessed approximately 1 year post breast reconstruction
- description
- 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)
- measure
- Comparison of digital video footage panel scores against patient self-assessment scores
- timeFrame
- Outcome measure will be assessed approximately 1 year post breast reconstruction
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGilmour 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 24923524