Breast Cancer
Conditions
Brief 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. Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up. 3. Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction. 4. TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.
Interventions
PROCEDURELatissimus dorsi flap
Breast reconstruction
PROCEDUREThoracodorsal artery perforator flap to breast
Breast reconstruction
Breast reconstruction
Sponsors
Vastra Gotaland Region
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients eligible for breast reconstruction following mastectomy and radiation * Non-smokers or ex-smokers (\>6 weeks) * BMI \< 30
Exclusion criteria
* Inability to leave informed consent * Inability to understand Swedish * Previous surgery with scaring on back
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction and breast-related quality of life after breast reconstruction | 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. |
| Abdominal satisfaction after breast reconstruction | 10 years | Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100 |
| Shoulder function after breast reconstruction | 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. |
| Back appearance after breast reconstruction | 10 years | Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome. |
| Back and shoulder function after breast reconstruction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications after breast reconstruction | 2 years | Measured in patients randomized to TDAP or latissimus dorsi flap. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Validation of Breast Q: The Back Appearance scale for Swedish | 1 year | Translation and validation of the instrument for Swedish |
| Normal material for Breast-Q back and shoulder function scale | 5 years | Measurement of quality of life according to breast-Q back and shoulder function scale in a normative population |
| Normal material for Breast-Q back appearance scale | 5 years | Measurement of quality of life according to breast-Q back appaearance scale in a normative population |
| Normal material for Breast-Q | 5 years | Measurement of quality of life according to breast-Q in a normative population |
| Validation of Breast-Q: The back and shoulder function scale for Swedish | 1 year | Translation and validation of the instrument for Swedish |
Countries
Sweden
Outcome results
None listed