Breast CancerNCT04526561
Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
A study testing Latissimus dorsi flap, Thoracodorsal artery perforator flap to breast and Deep inferior epigastric perforator flap in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts. 1. Validation of scales/instrument for Swedish. 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Latissimus dorsi flap, Thoracodorsal artery perforator flap to breast and Deep inferior epigastric perforator flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2020to 31 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients eligible for breast reconstruction following mastectomy and radiation
- Non-smokers or ex-smokers (>6 weeks)
- BMI < 30
Who cannot join
- Inability to leave informed consent
- Inability to understand Swedish
- Previous surgery with scaring on back
Trial locations and contacts
1 site in 1 country.
About this study
The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.
- Validation of scales/instrument for Swedish.
- Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.
- Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.
- TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.
- Conditions
- Breast Cancer
- Being tested
- Latissimus dorsi flap, Thoracodorsal artery perforator flap to breast, Deep inferior epigastric perforator flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latissimus dorsi flapProcedure or surgery
Also called LD flap
Breast reconstruction
Thoracodorsal artery perforator flap to breastProcedure or surgery
Also called TDAP
Breast reconstruction
Deep inferior epigastric perforator flapProcedure or surgery
Also called DIEP flap
Breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Breast reconstruction TDAP | Active comparator | Breast reconstruction performed with TDAP Receives: Procedure: Thoracodorsal artery perforator flap to breast |
| Breast reconstruction latissimus dorsi | Active comparator | Breast reconstruction performed with latissimus dorsi Receives: Procedure: Latissimus dorsi flap |
| Breast reconstruction with DIEP | Active comparator | Breast reconstruction performed with a deep inferior epigastric artery perforator flap Receives: Procedure: Deep inferior epigastric perforator flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction and breast-related quality of life after breast reconstruction
Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.
Measured: 10 years
Back and shoulder function after breast reconstruction
Breast Q the back and shoulder function scale. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Measured: 10 years
Back appearance after breast reconstruction
Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Measured: 10 years
Shoulder function after breast reconstruction
Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.
Measured: 10 years
Abdominal satisfaction after breast reconstruction
Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100
Measured: 10 years
Secondary outcomes (1)
Complications after breast reconstruction
Measured in patients randomized to TDAP or latissimus dorsi flap.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526561
- Sponsor's protocol ID
- 254-18
- Status last verified
- Jun 2025
- First submitted
- 12 Aug 2020
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamya L, Hansson E, Weick L, Hansson E. Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population. Health Qual Life Outcomes. 2021 Jul 3;19(1):174. doi: 10.1186/s12955-021-01812-x.
PubMed 34217326
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
- ClinicalTrials.gov ID
- NCT04526561
- Acronym / sponsor ID
- 254-18
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Aug 2020 (actual)
- 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.
The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.
- Validation of scales/instrument for Swedish.
- Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.
- Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.
- TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast reconstruction TDAP | Active comparator | Procedure: Thoracodorsal artery perforator flap to breastBreast reconstruction performed with TDAP |
| Breast reconstruction latissimus dorsi | Active comparator | Procedure: Latissimus dorsi flapBreast reconstruction performed with latissimus dorsi |
| Breast reconstruction with DIEP | Active comparator | Procedure: Deep inferior epigastric perforator flapBreast reconstruction performed with a deep inferior epigastric artery perforator flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients eligible for breast reconstruction following mastectomy and radiation
- Non-smokers or ex-smokers (>6 weeks)
- BMI < 30
Key exclusion criteria (3 listed)
- Inability to leave informed consent
- Inability to understand Swedish
- Previous surgery with scaring on back
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 |
|---|---|---|
| Latissimus dorsi flapAlso: LD flapBreast reconstruction | Procedure or surgery | Breast reconstruction latissimus dorsi |
| Thoracodorsal artery perforator flap to breastAlso: TDAPBreast reconstruction | Procedure or surgery | Breast reconstruction TDAP |
| Deep inferior epigastric perforator flapAlso: DIEP flapBreast reconstruction | Procedure or surgery | Breast reconstruction with DIEP |
Primary outcome
Patient satisfaction and breast-related quality of life after breast reconstruction
Time frame: 10 years
Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.
Back and shoulder function after breast reconstruction
Time frame: 10 years
Breast Q the back and shoulder function scale. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Back appearance after breast reconstruction
Time frame: 10 years
Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Shoulder function after breast reconstruction
Time frame: 10 years
Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.
Abdominal satisfaction after breast reconstruction
Time frame: 10 years
Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100
1 secondary outcome
Complications after breast reconstruction
Time frame: 2 years
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 9 Jul 2025.
- Results publication: PubMed 34217326Kamya L, Hansson E, Weick L, Hansson E. Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population. Health Qual Life Outcomes. 2021 Jul 3;19(1):174. doi: 10.1186/s12955-021-01812-x.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latissimus dorsi flap, Thoracodorsal artery perforator flap to breast and Deep inferior epigastric perforator flap in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 3 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Patient satisfaction and breast-related quality of life after breast reconstruction (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526561, which also lists 1 linked publication.
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 9 Jul 2025.