Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales

Study Overview
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Brief Summary
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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.

Official Title
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Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Latissimus dorsi flap
* Procedure: Thoracodorsal artery perforator flap to breast
* Procedure: Deep inferior epigastric perforator flap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Breast reconstruction TDAP<br>Breast reconstruction performed with TDAP | Procedure: Thoracodorsal artery perforator flap to breast<br>* Breast reconstruction<br>* Other names: TDAP;|
| Active Comparator: Breast reconstruction latissimus dorsi<br>Breast reconstruction performed with latissimus dorsi | Procedure: Latissimus dorsi flap<br>* Breast reconstruction<br>* Other names: LD flap;|
| Active Comparator: Breast reconstruction with DIEP<br>Breast reconstruction performed with a deep inferior epigastric artery perforator flap | Procedure: Deep inferior epigastric perforator flap<br>* Breast reconstruction<br>* Other names: DIEP flap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 10 years | 
| Abdominal satisfaction after breast reconstruction | Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100 | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications after breast reconstruction | Measured in patients randomized to TDAP or latissimus dorsi flap. | 2 years |