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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

Tracking Information
First Submitted Date July 29, 2016
First Posted Date August 2, 2016
Last Update Posted Date August 4, 2016
Study Start Date April 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2016)
Telemark Breast Score [ Time Frame: 2013-2014 ]
validation of Telemark Breast Score
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02853227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery
Official Title The Telemark Breast Score is a Valid Method for the Evaluation of Outcome After Reconstructive Surgery of the Breast
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).
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 2 cohorts, one subjected to BCS and one to DIEP surgery.
Condition 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.
Study Groups/Cohorts
  • BCS
    Photographs og consecutive group of 346 patients operated with breast conserving surgery were used to investigate cosmetic outcomes.
    Intervention: Other: digital photography
  • DIEP
    Photographs og consecutive group of 30 patients operated with DIEP-flap were used to assess cosmetic results
    Intervention: Other: digital photography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 29, 2016)
376
Original Actual Enrollment Same as current
Actual Study Completion Date November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients operated for breast cancer at Hospital of Telemark

Exclusion Criteria:

  • Patients operated for breast cancer and not subjected for irradiation
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02853227
Other Study ID Numbers 1097.13-1
2013/1197 ( Other Identifier: REC - Regional Commitee for Research Ethics )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Anadi Begic, Sykehuset Telemark
Study Sponsor Sykehuset Telemark
Collaborators Not Provided
Investigators Not Provided
PRS Account Sykehuset Telemark
Verification Date August 2016