Breast CancerTBSNCT02853227
The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery
An observational study of Breast Cancer, run by Sykehuset Telemark.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- digital photography
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 2 cohorts, one subjected to BCS and one to DIEP surgery.
Who may be able to join
- Patients operated for breast cancer at Hospital of Telemark
Who cannot join
- Patients operated for breast cancer and not subjected for irradiation
About this study
Official title: The Telemark Breast Score is a Valid Method for the Evaluation of Outcome After Reconstructive Surgery of the Breast
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).
Read the 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
- Breast Cancer
- Being tested
- digital photography
- Keywords
- Telemark score, reliability
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital photographyOther
Photographies with digital cameras were taken postoperatively for the documentation, anonymised and used for evaluation of cosmetic results after surgery.
| Study group | Role | What they receive |
|---|---|---|
| BCS | Photographs og consecutive group of 346 patients operated with breast conserving surgery were used to investigate cosmetic outcomes. Receives: Other: digital photography | |
| DIEP | Photographs og consecutive group of 30 patients operated with DIEP-flap were used to assess cosmetic results Receives: Other: digital photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telemark Breast Score
validation of Telemark Breast Score
Measured: 2013-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anadi Begic, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853227
- Sponsor's protocol ID
- 1097.13-1
- Other IDs
- 2013/1197
- Acronym
- TBS
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Telemark Breast Score is a Valid Method for the Evaluation of Outcome After Reconstructive Surgery of the Breast
- ClinicalTrials.gov ID
- NCT02853227
- Acronym / sponsor ID
- TBS / 1097.13-1
- Conditions
- Breast Cancer
- Keywords
- Telemark score, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCS | – | Other: digital photographyPhotographs og consecutive group of 346 patients operated with breast conserving surgery were used to investigate cosmetic outcomes. |
| DIEP | – | Other: digital photographyPhotographs og consecutive group of 30 patients operated with DIEP-flap were used to assess cosmetic results |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2 cohorts, one subjected to BCS and one to DIEP surgery.
Key inclusion criteria (1 listed)
- Patients operated for breast cancer at Hospital of Telemark
Key exclusion criteria (1 listed)
- Patients operated for breast cancer and not subjected for irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital photographyPhotographies with digital cameras were taken postoperatively for the documentation, anonymised and used for evaluation of cosmetic results after surgery. | Other | BCS, DIEP |
Primary outcome
Telemark Breast Score
Time frame: 2013-2014
validation of Telemark Breast Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sykehuset Telemark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telemark Breast Score (time frame: 2013-2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.