Clinical Trials Directory

Trials / Completed

CompletedNCT02853227

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
376 (actual)
Sponsor
Sykehuset Telemark · Other Government
Sex
Female
Age
Healthy volunteers
Not accepted

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).

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.

Conditions

Interventions

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

Timeline

Start date
2014-04-01
Primary completion
2014-11-01
Completion
2014-11-01
First posted
2016-08-02
Last updated
2016-08-04

Source: ClinicalTrials.gov record NCT02853227. Inclusion in this directory is not an endorsement.