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

Breast Cancer Clinical Trial

— TBS  

Official title:

The Telemark Breast Score is a Valid Method for the Evaluation of Outcome After Reconstructive Surgery of the Breast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853227
• Other study ID #: 1097.13-1
• Secondary ID: 2013/1197
• Status: Completed
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 3, 2016
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: August 2016
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients operated for breast cancer at Hospital of Telemark

Exclusion Criteria:

• Patients operated for breast cancer and not subjected for irradiation

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Telemark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telemark Breast Score	validation of Telemark Breast Score	2013-2014	No