Breast Cancer Female, Surgery--Complications
Conditions
Keywords
breast reconstruction, plastic surgery, microsurgery
Brief summary
A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
Interventions
PROCEDUREBreast reconstruction
Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Irradiated patients: Inclusion Criteria: * Age 18-60 * DIEP is technically possible * Unilateral mastectomy * BMI\<30
Exclusion criteria
* Scars on abdomen or back * Bilateral mastectomy * Previous liposuction abdomen * 61 years of age or older Non-irradiated patients Inclusion Criteria: -\>18 years of age * Unilateral mastectomy * BMI\<30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic outcome | 1 year post-operatively | Photo evaluations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General quality of life measurement used for health economics | Pre-operatively and 3 years post-operatively | EuroQol-5 domensions-3 levels is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health. |
| Depression | Pre-operatively and 3 years post-operatively | Beck Depression Inventory (BDI 21) for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome. |
| General quality of life | Pre-operatively and 3 years post-operatively | Short form health survey (SF-36). The scale ranges from 0 to 100 and a higher score indicates a better quality of life. |
| Breast related quality of life and satisfaction | Pre-operatively and 3 years post-operatively | Breast-q. Measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life. |
| Long-term complications | Five years post-operatively | Re-operations and corrections |
| Health economics | Five years post-operatively | Costs of different procedures |
| Implant survival (Ancillary study) | 19 years | Analysis of number of implants removed over time (Ethical permit: 2021-06131-02) |
| Early complication frequency | 2 weeks post-operatively | Complications described according to Clavien-Dindo |
Outcome results
None listed