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Autologous vs. Implant-based Breast Reconstruction

RecruitingNAAges 18 Years - anyFemaleVastra Gotaland Region
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In plain words

What the trial is, and whether it could suit you

Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Biological female * \>18 years of age * American Society of anesthesiologist classification (ASA) 1-2 * Patient must have had or be scheduled for a mastectomy * Ability to give informed consent * Ability to communicate in Swedish Exclusion Criteria: * ASA \> 2 * BMI \> 30 kg/m2 * Smoking1 radiotherapy to the breast in question. * Radiotherapy is expected post-operatively. * Locally advanced breast cancer * Metastasised breast cancer * Comorbidity and/or drugs that affect wound healing. * Unstable psychiatric co-morbidity * Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable
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What it tests

  • DIEP-flap
  • Implant
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Where

2 sites
Sahlgrenska university hospital
Gothenburg, Sweden
Sahlgrenska university hospital
Gothenburg, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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