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The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery (TBS)

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ClinicalTrials.gov Identifier: NCT02853227
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Anadi Begic, Sykehuset Telemark

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).

Condition or disease Intervention/treatment
Breast Cancer Other: digital photography

Detailed Description:

Background: Validated instruments for assessing results after breast surgery are sparse. Investigators want to present a method used for the past 10 years at their institution for evaluation of the outcome after breast conserving surgery (BCS) and microsurgical breast reconstruction. Methods: 346 consecutive patients subjected to BCS for cancer and 30 patients operated with a deep inferior epigastric flap (DIEP ) were assessed at least one year after the operation. The Telemark Breast Score is a method based on standard two-dimensional photographs assessing the outcome after breast surgery in terms of volume, shape and symmetry. Three different panels including plastic surgeons, breast surgeons and nurses were invited to test the Telemark Breast Score. Consistency of agreement between and inside the panel groups was studied Results: Inter- and intra observer reliability was acceptable. Good stability of ratings could be shown in test-retests.

Conclusion: The Telemark Breast Scale is inexpensive, statistically reliable and can be applied for quality control after breast surgery.


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Study Type : Observational
Actual Enrollment : 376 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Telemark Breast Score is a Valid Method for the Evaluation of Outcome After Reconstructive Surgery of the Breast
Study Start Date : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Group/Cohort Intervention/treatment
BCS
Photographs og consecutive group of 346 patients operated with breast conserving surgery were used to investigate cosmetic outcomes.
Other: digital photography
Photographies with digital cameras were taken postoperatively for the documentation, anonymised and used for evaluation of cosmetic results after surgery.

DIEP
Photographs og consecutive group of 30 patients operated with DIEP-flap were used to assess cosmetic results
Other: digital photography
Photographies with digital cameras were taken postoperatively for the documentation, anonymised and used for evaluation of cosmetic results after surgery.




Primary Outcome Measures :
  1. Telemark Breast Score [ Time Frame: 2013-2014 ]
    validation of Telemark Breast Score



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
2 cohorts, one subjected to BCS and one to DIEP surgery.
Criteria

Inclusion Criteria:

  • Patients operated for breast cancer at Hospital of Telemark

Exclusion Criteria:

  • Patients operated for breast cancer and not subjected for irradiation

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Responsible Party: Anadi Begic, overlege, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT02853227     History of Changes
Other Study ID Numbers: 1097.13-1
2013/1197 ( Other Identifier: REC - Regional Commitee for Research Ethics )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anadi Begic, Sykehuset Telemark:
Telemark score, reliability