NCT02853227

Brief Summary

This paper will present a specific tool for evaluation of cosmetic results after breast conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap. Introduction of a breast score system using digital photography seems to be a reliable tool for estimation of cosmetic results after breast surgery. The method has been employed on a specific group of 346 consecutive patients operated for breast cancer with breast conserving surgery. For the purpose of this study breast score system was tested on patients with free flap breast reconstruction (DIEP flap).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

July 29, 2016

Last Update Submit

August 3, 2016

Conditions

Breast Cancer

Keywords

Telemark score, reliability

Outcome Measures

Primary Outcomes (1)

  • Telemark Breast Score

    validation of Telemark Breast Score

    2013-2014

Study Arms (2)

BCS

Photographs og consecutive group of 346 patients operated with breast conserving surgery were used to investigate cosmetic outcomes.

Other: digital photography

DIEP

Photographs og consecutive group of 30 patients operated with DIEP-flap were used to assess cosmetic results

Other: digital photography

Interventions

digital photographyOTHER

Photographies with digital cameras were taken postoperatively for the documentation, anonymised and used for evaluation of cosmetic results after surgery.

BCSDIEP

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2 cohorts, one subjected to BCS and one to DIEP surgery.

You may qualify if:

  • Patients operated for breast cancer at Hospital of Telemark

You may not qualify if:

  • Patients operated for breast cancer and not subjected for irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
overlege

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 2, 2016

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share