Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods

Conditions
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Breast Cancer Female, Surgery--Complications

Intervention / Treatment
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* Procedure: Breast reconstruction


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Bilateral mastectomy extensive scars on thorax

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Irradiated women<br>Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. | Procedure: Breast reconstruction<br>* 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.<br>|
| Other: Non-irradiated women<br>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. | Procedure: Breast reconstruction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic outcome | Photo evaluations | 1 year post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast related quality of life and satisfaction | Breast-q. Measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life. | Pre-operatively and 3 years post-operatively | 
| General quality of life measurement used for health economics | 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. | Pre-operatively and 3 years post-operatively | 
| Depression | Beck Depression Inventory (BDI 21) for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome. | Pre-operatively and 3 years post-operatively | 
| General quality of life | Short form health survey (SF-36). The scale ranges from 0 to 100 and a higher score indicates a better quality of life. | Pre-operatively and 3 years post-operatively | 
| Early complication frequency | Complications described according to Clavien-Dindo | 2 weeks post-operatively | 
| Long-term complications | Re-operations and corrections | Five years post-operatively | 
| Health economics | Costs of different procedures | Five years post-operatively | 
| Implant survival | Analysis of number of implants removed over time | 19 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, plastic surgery, microsurgery